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Background: It is not clear whether use of specialty palliative care consults and “comfort measures only” (CMO) order sets differ by type of intensive care unit (ICU). A better understanding of palliative care provided to these patients may help address heterogeneity of care across ICU types. Objectives: Examine utilization of specialty palliative care consultation and CMO order sets across several different ICU types in a multihospital academic health care system. Design: Retrospective cohort study using Washington State death certificates and data from the electronic health record. Setting/Subjects: Adults with a chronic medical illness who died in an ICU at one of two hospitals from July 2013 through December 2018. Five ICU types were identified by patient population and attending physician specialty. Measurements: Documentation of a specialty palliative care consult during a patient's terminal ICU stay and a CMO order set at time of death. Results: For 2706 eligible decedents, ICU type was significantly associated with odds of palliative care consultation (p

BACKGROUND AND AIMS: In a United States randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72%-XR-NTX vs. 94%-BUP-NX). This led to higher relapse rates and average healthcare costs among XR-NTX participants. This study estimated the extent to which a more efficient model of XR-NTX induction would improve the economic value of XR-NTX relative to BUP-NX. DESIGN: This was a retrospective secondary analysis of CTN-0051 trial data, including follow up data over 24–36 weeks. SETTING: Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the USA. PARTICIPANTS: 283 participants randomized to receive XR-NTX. MEASUREMENTS: Efficiency was estimated using a multivariable generalized-structural-equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the healthcare sector perspective and included expected costs and quality-adjusted life-years (QALYs). FINDINGS: Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5,317 more than that of BUP-NX (p=0.01) to a non-statistically-significant difference of $1,016 (p=0.63). QALYs gained remained similar across arms. CONCLUSION: Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the healthcare sector perspective over 24–36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility.

Purpose Young adults are disproportionately affected by the current opioid crisis. Although medications for opioid use disorder are broadly effective, with reductions in morbidity and mortality, the particular effectiveness of medications for opioid use disorder among young adults is less well understood. Methods This secondary analysis compared young adults (aged 18–25 years) with older adults (aged ≥26 years) in a large comparative effectiveness trial (“XBOT”) that randomized subjects to extended-release naltrexone or sublingual buprenorphine–naloxone for 6 months. Opioid relapse was defined by opioid use over four consecutive weeks or seven consecutive days, using urine testing and self-report. Results Among subjects in the intention-to-treat sample (n = 570, all randomized participants), a main effect of age group was found, with higher relapse rates among young adults (70.3%) compared with older adults (58.2%), with an odds ratio of 1.72 (95% confidence interval = 1.08–2.70), p = .02. In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19–3.06). Among the intention-to-treat sample, survival analysis revealed a significant time-by-age group interaction (p = .01) with more relapse over time in young adults. No significant interactions between age and medication group were detected. Conclusions Young adults have increased rates of relapse compared with older adults, perhaps because of vulnerabilities that increase their risk for treatment dropout and medication nonadherence, regardless of medication assignment. These results suggest that specialized, developmentally informed interventions may be needed to improve retention and successful treatment of opioid use disorder among young adults.

Rationale: Patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) typically undergo frequent clinical evaluation. The incidence and outcomes of coronavirus disease (COVID-19) and its impact on routine management for patients with pulmonary vascular disease is currently unknown. Objectives: To assess the cumulative incidence and outcomes of recognized COVID-19 for patients with PAH/CTEPH followed at accredited pulmonary hypertension centers, and to evaluate the pandemic’s impact on clinic operations at these centers. Methods: A survey was e-mailed to program directors of centers accredited by the Pulmonary Hypertension Association. Descriptive analyses and linear regression were used to analyze results. Results: Seventy-seven center directors were successfully e-mailed a survey, and 58 responded (75%). The cumulative incidence of COVID-19 recognized in individuals with PAH/CTEPH was 2.9 cases per 1,000 patients, similar to the general U.S. population. In patients with PAH/CTEPH for whom COVID-19 was recognized, 30% were hospitalized and 12% died. These outcomes appear worse than the general population. A large impact on clinic operations was observed including fewer clinic visits and substantially increased use of telehealth. A majority of centers curtailed diagnostic testing and a minority limited new starts of medical therapy. Most centers did not use experimental therapies in patients with PAH/CTEPH diagnosed with COVID-19. Conclusions: The cumulative incidence of COVID-19 recognized in patients with PAH/CTEPH appears similar to the broader population, although outcomes may be worse. Although the total number of patients with PAH/CTEPH recognized to have COVID-19 was small, the impact of COVID-19 on broader clinic operations, testing, and treatment was substantial.

Key Points Question Is extended-release buprenorphine an acceptable and helpful jail-to-community treatment option among adults already receiving daily sublingual buprenorphine for opioid use disorders? Findings In this pilot proof-of-concept comparative effectiveness study of 52 incarcerated adults with opioid use disorders, extended-release buprenorphine was acceptable to most participants, making it a feasible option in the setting of a large jail opioid treatment program; community buprenorphine treatment retention at 8 weeks postrelease was relatively high compared with sublingual buprenorphine. Meaning These results suggest that monthly injectable extended-release buprenorphine was a useful opioid use disorder treatment option before and after release from jail., This comparative effectiveness study assesses the effectiveness of extended-release buprenorphine injections to treat opioid use disorder among adults transitioning from jail to the community compared with daily sublingual buprenorphine treatment., Importance Extended-release buprenorphine (XRB), a monthly injectable long-acting opioid use disorder (OUD) treatment, has not been studied for use in corrections facilities. Objective To compare treatment retention following release from jail among adults receiving daily sublingual buprenorphine-naloxone (SLB) vs those receiving XRB. Design, Setting, and Participants This open-label, randomized comparative effectiveness study included 52 incarcerated adults in New York City observed for 8 weeks postrelease between June 2019 and May 2020. Participants were soon-to-be-released volunteers from 1 men’s and 1 women’s jail facility who had OUDs already treated with SLB. Follow-up treatment was received at a primary care clinic in Manhattan. Data were analyzed between June 2020 and December 2020. Interventions XRB treatment was offered prior to release and continued monthly through 8 weeks after release. SLB participants continued to receive daily directly observed in-jail SLB administration, were provided a 7-day SLB supply at jail release, and followed up at a designated clinic (or other preferred clinics). Main Outcomes and Measures Buprenorphine treatment retention at 8 weeks postrelease. Results A total of 52 participants were randomized 1:1 to XRB (26 participants) and SLB (26 participants). Participants had a mean (SD) age of 42.6 (10.0) years; 45 participants (87%) were men; and 40 (77%) primarily used heroin prior to incarceration. Most participants (30 [58%]) reported prior buprenorphine use; 18 (35%) reported active community buprenorphine treatment prior to jail admission. Twenty-one of 26 assigned to XRB received 1 or more XRB injection prior to release; 3 initiated XRB postrelease; and 2 did not receive XRB. Patients in the XRB arm had fewer jail medical visits compared with daily SLB medication administration (mean [SD] visits per day: XRB, 0.11 [0.03] vs SLB, 1.06 [0.08]). Community buprenorphine treatment retention at week 8 postrelease was 18 participants in the XRB group (69.2%) vs 9 in the SLB group (34.6%), and rates of opioid-negative urine tests were 72 of 130 tests in the XRB group (55.3%) and 50 of 130 tests in the SLB group (38.4%). There were no differences in rates of serious adverse events, no overdoses, and no deaths. Conclusions and Relevance XRB was acceptable among patients currently receiving SLB, and patients had fewer in-jail clinic visits and increased community buprenorphine treatment retention when compared with standard daily SLB treatment. These results support wider use and further study of XRB as correctional and reentry OUD treatment. Trial Registration ClinicalTrials.gov Identifier: NCT03604159

This report examined naturalistic opioid use outcomes and utilization of medications for opioid use disorder (MOUD) 36 weeks post-randomization in the National Drug Abuse Treatment Clinical Trials Network (CTN) Extended-Release Naltrexone (XR-NTX) versus Buprenorphine-Naloxone (BUP-NX) for Opioid Treatment trial (CTN-0051, X:BOT).X:BOT was a multisite, randomized, 24-week comparative effectiveness trial of BUP-NX (N = 287) and XR-NTX (N = 283). Study medications were discontinued following treatment completion, relapse, or dropout. Participants were encouraged to continue MOUD. This report examined opioid use outcomes in 428 (75%) of the 570 participants who attended the 36-week follow-up visit.Adults with opioid use disorder recruited from 8 community treatment programs across the United States.Outcomes included medication status (on/off MOUD), type of MOUD (BUP-NX, XR-NTX, or methadone), abstinence from non-prescribed opioids, opioid use days, relapse, and other substance use 30 days prior to the 36-week visit. Relapse was defined as opioid use for 4 consecutive weeks or 7 consecutive days in the past month. Baseline and clinical variables included opioid use severity, intravenous drug use, study medication assignment, and induction status.Of the 428 participants who completed the 36-week visit, 225 (53%) of participants were receiving MOUD and 203 (47%) were not. Compared to those off medication, participants on medication had fewer opioid use days (4.4 days (SD 9.0) versus 9.8 days (SD 12.1)), fewer met relapse criteria (37 (16.4%) versus 79 (38.9%)), and reported less stimulant use (34 (15.2%) versus 56 (27.7%)) and sedative use (14 (6.3%) versus 31 (15.3%)). There was no difference in abstinence rates between those on or off MOUD. A greater proportion of participants on XR-NTX (47 (53.4%) of 88 participants) were abstinent from non-prescribed opioids compared to those on buprenorphine (28 (23.3%) of 120 participants).Naturalistic outcomes data showed that despite potential barriers to continuing treatment in the community, about half of individuals were on opioid use disorder pharmacotherapy at follow-up and those on medication generally had better outcomes. Future research should explore barriers and facilitators to treatment retention in community settings; and developing interventions tailored to improve treatment engagement and adherence.

Sublingual buprenorphine-naloxone and extended-release injection naltrexone are effective treatments, with distinct mechanisms, for opioid use disorder. The authors examined whether patients' demographic and clinical characteristics were associated with better response to one medication or the other.In a multisite 24-week randomized comparative-effectiveness trial of assignment to buprenorphine-naloxone (N=287) compared with extended-release naltrexone (N=283) comprising inpatients planning to initiate medication treatment for opioid use disorder, 50 demographic and clinical characteristics were examined as moderators of the effect of medication assignment on relapse to regular opioid use and failure to initiate medication. Moderator-by-medication interactions were estimated using logistic regression with correction for multiple testing.In the intent-to-treat sample, patients who reported being homeless had a lower relapse rate if they were assigned to receive extended-release naltrexone (51.6%) compared with buprenorphine-naloxone (70.4%) (odds ratio=0.45, 95% CI=0.22, 0.90); patients who were not homeless had a higher relapse rate if they were assigned to extended-release naltrexone (70.9%) compared with buprenorphine-naloxone (53.1%) (odds ratio=2.15, 95% CI=1.44, 3.21). In the subsample of patients who initiated medication, the interaction was not significant, with a similar pattern of lower relapse with extended-release naltrexone (41.4%) compared with buprenorphine (68.6%) among homeless patients (odds ratio=0.32, 95% CI=0.15, 0.68) but less difference among those not homeless (extended-release naltrexone, 57.2%; buprenorphine, 52.0%; odds ratio=1.24, 95% CI=0.80, 1.90). For failure to initiate medication, moderators were stated preference for medication (failure was less likely if the patient was assigned to the medication preferred), parole and probation status (fewer failures with extended-release naltrexone for those on parole or probation), and presence of pain and timing of randomization (more failure with extended-release naltrexone for patients endorsing moderate to severe pain and randomized early while still undergoing medically managed withdrawal).Among patients with opioid use disorder admitted to inpatient treatment, homelessness, parole and probation status, medication preference, and factors likely to influence tolerability of medication initiation may be important in matching patients to buprenorphine or extended-release naltrexone.

Highlights • We estimated prevalence of e-cigarette dual use among smokers with substance use disorders. • Dual e-cigarette users were more likely to have tried to quit in the past year. • Overall, participants preferred to use e-cigarettes in comparison to nicotine patches/gum. • E-cigarettes seem appealing to patients with substance use disorders. • E-cigarette use may be effective for harm reduction among patients in addiction treatment., Background We explored characteristics and beliefs associated with e-cigarette use patterns among cigarette smokers requiring inpatient detoxification for opioid and/or alcohol use disorder(s). Methods Adult cigarette smokers (≥18 years), admitted to inpatient detoxification for alcohol and/or opioid use disorder(s) in a safety-net tertiary referral center in New York City were surveyed in 2015 (n = 158). Descriptive statistics (proportions) were used to assess for demographic, clinical diagnosis, cigarette smoking patterns (exclusive and dual use of e-cigarettes). Chi-square, t-test statistics, and logistic regression models were used. Results Among our sample of combustible cigarette users, 13.9% (n = 22) reported dual use with electronic cigarettes. Dual use did not differ by demographic or clinical variables. Compared to exclusive smokers, dual users were more likely to have tried to quit in the past year (Adjusted Odds ratio = 8.59; CI: 2.58, 28.35; p

Background Few studies have documented patient attitudes and experiences with extended-release naltrexone (XR-NTX) opioid relapse prevention in criminal justice settings. This study assessed barriers and facilitators of jail-to-community reentry among adults with opioid use disorder (OUD) treated with XR-NTX, buprenorphine, methadone, and no medications. Methods This qualitative study conducted individual interviews with a purposeful and convenience sample of adults with OUD who were recently released from NYC jails. XR-NTX, no medication, and methadone participants were concurrently enrolled in a large randomized controlled trial evaluating XR-NTX vs. a no medication Enhanced Treatment As Usual (ETAU) condition, or enrolled in a non-randomized quasi-experimental methadone maintenance cohort. Buprenorphine participants were referred from NYC jails to a public hospital office-based buprenorphine program and not enrolled in the parent trial. Interviews were audio recorded, transcribed, independently coded by two researchers, and analyzed per a grounded theory approach adapted to the Social Cognitive Theory framework. The research team reviewed transcripts and coding to reach consensus on emergent themes. Results N = 33 adults with OUD (28 male, 5 female) completed a single individual interview. Purposeful sampling recruited persons leaving jail on XR-NTX (n = 11), no active medication treatment (n = 9), methadone (n = 9), and buprenorphine (n = 4). Emergent themes were: (1) general satisfaction with XR-NTX’s long-acting antagonist effects and control of cravings; (2) “testing” XR-NTX’s blockade with heroin upon reentry was common; (3) early discontinuation of XR-NTX treatment was most common among persons with high self-efficacy and/or heavy exposure to drug use environments and peers; (4) similar satisfaction regarding effects of methadone and buprenorphine maintenance among retained-in-treatment individuals, alongside general dissatisfaction with daily observed dosing requirements and misinformation and stigmas regarding methadone adverse effects; (5) unstable housing, economic insecurity, and exposure to actively using peers were attributed to early termination of treatment and relapse; (6) individual motivation and willpower as central to long-term opioid abstinence and reentry success. Conclusions In the context of more familiar agonist maintenance treatments, XR-NTX relapse prevention during jail-to-community reentry was viewed as a helpful and unique intervention though with important limitations. Commonly described barriers to treatment retention and heroin abstinence included homelessness, economic insecurity, and drug-using peers. Trial registration ClinicalTrials.gov, NCT01999946 (XOR), Registered 03 December 2013, https://clinicaltrials.gov/ct2/show/NCT01999946.

Abdominal aortic disease affects more than 3 million people per year. For vascular sonographers, imaging aortic disease can become routine. Therefore, it is necessary to expand the knowledge that we have of aortic disease, diagnosis, and treatment. We present 4 cases with new or worsening conditions diagnosed by duplex ultrasound (DUS). Our first case is a 79-year-old woman returning for surveillance of an endovascular aneurysm repair (EVAR). The DUS findings reveal an increasing abdominal aortic aneurysm (AAA) sac, with evidence of flow originating from an incomplete seal at the attachment suggesting type I endoleak. Next, is a 56-year-old man returning 1 month after type A dissection repair, now presenting with unilateral claudication. The DUS findings of the left lower extremity demonstrated an early systolic deceleration waveform, suggesting more proximal disease. Upon further imaging, an abdominal aortic dissection was identified terminating into the left internal iliac artery, causing the true lumen to be compressed. The third case was a 75-year-old man returning for follow-up of an EVAR and iliac repair. The DUS findings show an increase in iliac artery sac size and anechoic area that was filled with color Doppler flow. These findings are suggestive of type I endoleak involving the distal attachment. The last case is a 56-year-old man returning for EVAR and iliac artery repair surveillance. The common iliac artery aneurysm sac had increased in diameter and length. The distal attachment of the left iliac extension cuff terminated within the aneurysm sac, causing a type I endoleak. Accurate DUS diagnosis of aortic disease is crucial for patient care. Meticulous analysis of the vessels and surrounding structures can make a difference in diagnostic outcomes. Vascular sonographers should continually review and revise vascular laboratory protocols to increase their diagnostic accuracy and improve patient care. It is important to extend the vascular laboratory protocols when complex cases arise to better demonstrate complicated diagnoses and challenging anatomy.

Due to the limited number of critical care providers in the United States, even well-staffed hospitals are at risk of exhausting both physical and human resources during the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). One potential response to this problem is redeployment of non-critical care providers to increase the supply of available clinicians. To support efforts to increase capacity as part of surge preparation for the coronavirus disease (COVID-19) outbreak, we created an online educational resource for non-intensivist providers to learn basic critical care content. Among those materials, we created a series of one-page learning guides for the management of common problems encountered in the intensive care unit (ICU). These guides were meant to be used as just-in-time tools to guide problem-solving during the provision of ICU care. This article presents five guides related to managing complications that can arise in patients receiving invasive mechanical ventilation.

Due to the limited number of critical care providers in the United States, even well-staffed hospitals are at risk of exhausting both physical and human resources during the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). One potential response to this problem is redeployment of non-critical care providers to increase the supply of available clinicians. To support efforts to increase capacity as part of surge preparation for the coronavirus disease (COVID-19) outbreak, we created an online educational resource for nonintensivist providers to learn basic critical care content. Among those materials, we created a series of one-page learning guides for the management of common problems encountered in the intensive care unit (ICU). These guides were meant to be used as just-in-time tools to guide problem-solving during the provision of ICU care. This article presents five guides related to the evaluation and management of patients with hypoxemic respiratory failure and the basics of invasive mechanical ventilation.

Despite high rates of Hepatitis C virus (HCV) infection among people who use drugs (PWUDs), access to the HCV care continuum combined with the receipt of medications for addiction treatment in primary care settings remains suboptimal. A qualitative study was conducted among adults admitted for inpatient detoxification for opioid use disorder (OUD) in New York City (n=23) to assess barriers and facilitators with HCV prevention, screening, treatment, interactions with primary care providers, and experiences with integrated care approaches. Study findings yielded six major themes related to HCV care. Major gaps persist in knowledge regarding HCV harm reduction strategies, voluntary HCV testing services, and eligibility for HCV treatment. Treatment coordination challenges reinforce the importance of enhancing linkages to HCV care in key access-points utilized by PWUDs (e.g., emergency rooms, specialty addiction treatment settings). Peer networks combined with frequent patient-physician communication were elicited as important factors in facilitating linkage to HCV care. Additional care coordination needs in primary care settings included access to integrated treatment of HCV and OUD, and administrative support for enrollment in Medicaid, subsidized housing, and access to transportation vouchers.

BACKGROUND: Smoking remains a major public health burden among persons with opioid and/or alcohol use disorder. METHODS: A 49-item semi-structured survey was conducted among urban, inpatient detoxification program patients eliciting demographic and clinical characteristics, smoking profile, technology use patterns, and preferences for adopting technology-based smoking cessation interventions. Multivariate logistic regression models further evaluated the association between participant demographic and clinical characteristics and technology preferences. RESULTS: Participants were mostly male (91%), and admitted for detoxification for alcohol (47%), heroin (31%), or both alcohol and heroin (22%). Past 30-day smoking was reported by 78% of the sample. Mobile phone ownership was common (89%); with an average past-year turnover of 3 mobile phones and 3 phone numbers. Computer ownership was low (28%) and one third reported daily internet use (34%). Telephone (41%) and text message-based interventions (40%) were the most popular platforms to facilitate smoking cessation. CONCLUSIONS: Despite concurrent AUD-OUD, most respondents had attempted to quit smoking in the last year and preferred telephone- and text message-based interventions to facilitate smoking cessation. High turnover of mobile phones, phone numbers, and limited access to computers pose barriers to dissemination of technology-based smoking cessation interventions in this vulnerable population.

BACKGROUND: Sublingual buprenorphine-naloxone (BUP-NX), an FDA-approved treatment for opioid use disorder (OUD) combines buprenorphine, a partial mu/kappa agonist with naloxone, a mu/kappa antagonist. Extended-release injection naltrexone (XR-NTX), also an FDA-approved treatment for OUD, is an antagonist at the mu receptor and partial agonist at the kappa receptor. However, only a fraction of patients responds well, while some drop out of treatment and relapse. OBJECTIVES: Determine whether gene variants in the opioid gene system are associated with better or worse treatment response. METHODS: In a 24-week, multisite, randomized, comparative effectiveness trial of daily, sublingual self-administration of BUP-NX versus monthly injection of XR-NTX conducted in the National Drug Abuse Clinical Trials Network, DNA was collected and four opioid gene variants were evaluated: (1) mu opioid receptor 118A>G; (2) 68-bp repeat in prodynorphin; (3) prodynorphin SNP rs910080; and (4) kappa opioid receptor SNP rs6473797. In non-Hispanic Caucasians (N = 334), separate logistic regressions were used to model two outcomes: (1) receiving the first dose of medication, and among those (2) receiving the last dose of medication (or completion of treatment) as a function of treatment (XR-NTX vs BUP-NX), each gene variant, and their interaction. RESULTS: There were no significant gene variant by treatment interactions, nor were there significant main effects on receiving the first dose, nor completion of treatment. CONCLUSIONS: The outcome of treatment of OUD with medications is likely a complex function of multiple factors, environmental, psychosocial, and possibly genetic, such that major effects of genetic variants may be unlikely.

Background Buprenorphine treatment remains unavailable in many jails and prisons, but use of nonprescribed (i.e., diverted) buprenorphine has been reported in these settings. The purpose of this analysis is to explore the experiences and motivations behind the use of diverted buprenorphine among recently incarcerated individuals. Methods Adults with opioid misuse who were recently released from jail or prison (n= 26; 58% male) completed semi-structured qualitative interviews as part of a study focused on buprenorphine diversion in the criminal justice system. Qualitative interviews explored participants' incarceration experiences and opioid use background, knowledge of buprenorphine and other substance use in jails/prisons, personal use of buprenorphine while incarcerated, reasons for using buprenorphine while incarcerated, and knowledge of how buprenorphine is brought into and acquired in jails/prisons. The study recorded and transcribed interviews, and analyzed the narratives for content related to these predetermined thematic areas. Results Key themes emerging from the interviews surrounding buprenorphine diversion during incarceration included: 1) the perceived high prevalence of diverted buprenorphine in jail/prison settings, 2) how the perception of prevalence is related to buprenorphine sublingual film formulation, 3) adaptive routes of administration related to the high cost of diverted buprenorphine, and 4) reasons individuals who are incarcerated use diverted buprenorphine (to achieve euphoric effects and cope with confinement, in contrast to using for self-treatment/withdrawal management as is done in the community). Conclusion Participants reported widespread availability of diverted buprenorphine in criminal justice facilities, and characterized reasons for its use specific to these contexts. More research is needed to determine the impact of expanding buprenorphine treatment in jails and prisons on inmates' use of diverted buprenorphine, and future research should explore these intersections as treatment initiation opportunities.

Case Presentation A 79-year-old man with medical history of atrial fibrillation and esophageal cancer status post trans-hiatal esophageal resection and chemotherapy presented with altered mental status after outpatient esophagogastroduodenoscopy (EGD). One month before presentation, the patient was seen at another hospital with severe anemia and melena requiring transfusion of multiple units of RBCs. No endoscopy was performed during that admission, but his anticoagulation was held. After follow-up with his oncologist, he was referred for outpatient endoscopy. His esophagogastroduodenoscopy demonstrated an intact esophagogastric anastomosis as well as two gastric ulcers with no stigmata of recent bleeding. The patient was discharged to home in good condition with normal mental status. Several hours later, he developed a deteriorating level of consciousness, prompting presentation to the hospital.

BACKGROUND: Extended-release naltrexone (XR-NTX) is an effective maintenance treatment for opioid use disorder, but induction from active opioid use is a challenge as individuals must complete detoxification before induction. We aimed to determine whether use of methadone or buprenorphine, long acting agonist opioids commonly used for detoxification, were associated with decreased likelihood of induction onto XR-NTX. METHODS: We performed a secondary analysis of a large open-label randomized trial of buprenorphine versus XR-NTX for treatment of individuals with opioid use disorder recruited from eight short term residential (detoxification) units. This analysis only included individuals randomized to the XR-NTX arm of the trial (N= 283). The method of detoxification varied according to usual practices at each inpatient program. Logistic regression models estimating the log-odds of induction onto XR-NTX were fit, with detoxification regimen received as the predictor. RESULTS: In the unadjusted logistic regression model, detoxification drug received (either methadone or buprenorphine) was significantly associated with decreased likelihood of induction onto XR-NTX compared to receiving non-opioid detoxification (Overall: P

Our intuitive understanding of adaptation by natural selection is dominated by the power of selection at early ages in large populations. Yet, as the forces of natural selection fall with adult age, we expect adaptation to be attenuated with age. Explicit simulations of age-dependent adaptation suggest that populations adapt to a novel environment quickly at early ages, but only slowly and incompletely at later adult ages. Experimental tests for age-dependent adaptation to a novel diet were performed on populations of Drosophila melanogaster. The results support the prediction that populations should perform better on an ancestral, long-abandoned diet, compared to an evolutionarily recent diet, only at later ages. D. melanogaster populations also perform poorly on a novel diet compared to an evolutionarily recent diet that has been sustained for hundreds of generations, particularly at earlier ages. Additional experiments demonstrate that the timing of the shift to better performance in our populations on the long-abandoned diet is dependent on when the forces of natural selection weaken in the evolutionary history of experimental populations. Taken together, these experimental findings suggest that the forces of natural selection scale the rate of adaptation to novel environments.

Background Extended release naltrexone (XR-NTX) injected intramuscularly monthly has been shown to reduce relapse in persons with opioid use disorder. Baseline factors, including patients' demographics, comorbidities and lifestyle, may help identify patients who will benefit most or least from XR-NTX treatment. Methods Potential moderators of XR-NTX's effect were examined in the largest North American randomized open-label effectiveness trial of XR-NTX. Relapse status (Yes/No) at 6-month follow-up was regressed on treatment group (XR-NTX, N=153; or Treatment-as-Usual [TAU], N=155), baseline covariates, and their two-way interaction to identify moderator effects. Baseline covariates included age, gender, summary scores for depression, suicidal thoughts, drug abuse risk, substance use, medical, psychiatric and employment status, socialization, legal and family/social issues, history of abuse and quality of life measures. Results Alcohol use to intoxication in the 30days before randomization was a significant moderator: during the treatment phase, those who reported being recently intoxicated before randomization to XR-NTX relapsed to opioids at a rate (56%) similar to TAU (58%), while those without alcohol intoxication in the prior 30days had a lower rate of opioid relapse (41% vs. 65%, respectively, P Conclusions XR-NTX appeared to work equally well across subgroups with diverse demographic, addiction, mental health and environmental characteristics, with the possible exception of working better among those without recent alcohol intoxication. These findings should be reassuring to practitioners increasingly using XR-NTX as medical addiction therapy in diverse and often vulnerable populations.

Background Opioid use disorders have reached epidemic proportions, with overdose now the leading cause of accidental death in the United States. Extended release naltrexone (XR-NTX) has emerged as a medication treatment that reduces opioid use and craving. However, the effect of XR-NTX therapy on acute healthcare utilization, including emergency department visits and inpatient hospitalizations, remains uncertain. The objective of the current study is to evaluate hospital-based healthcare resource utilization in adults involved in the criminal justice system with a history of opioid use disorder randomized to XR-NTX therapy compared with treatment as usual (TAU) during a 6-month treatment phase and 12months post-treatment follow up. Methods This retrospective exploratory analysis uses data collected in a published randomized trial. Comparisons of the number of emergency department visits and hospital admissions (for drug detox, psychiatric care and other medical reasons) were performed using chi square tests for any admission and negative binomial models for number of admissions. Results Of the 308 participants randomized, 96% had utilization data (76% complete 6months, 67% complete follow up). No significant differences were seen in overall healthcare utilization (IRR=0.88, 95%CI 0.63–1.23, p =0.45), or substance use-related drug detox hospitalizations (IRR=0.83, 95%CI 0.32–2.16, p =0.71). Despite having more participants report chronic medical problems at baseline (43% vs. 32%, p =0.05), those receiving XR-NTX generally experienced equivalent or lower rates of healthcare utilization compared to TAU. The XR-NTX group had significantly lower medical/surgical related hospital admissions (IRR=0.55, 95%CI 0.30–1.00, p =0.05) during the course of the entire study. Conclusions XR-NTX did not significantly increase rates of healthcare utilization compared to TAU. Provider concerns regarding healthcare utilization should not preclude the consideration of XR-NTX as therapy for opioid use disorders.

Opioid use disorder is often treated with short term hospitalization and medically supervised withdrawal from opioids followed by counseling alone without medication assisted treatment (MAT). More evidence is needed to confirm the expectation that the rate of relapse would be high after short term inpatient treatment and withdrawal from opioids without follow-up MAT.To examine relapse to opioid use disorder in a randomized, multi-site effectiveness trial of extended-release injection naltrexone (XR-NTX) vs community-based treatment as usual (TAU) without medication, as a function of the type of clinical service where treatment was initiated-short-term inpatient (N=59), long-term inpatient (N=48), or outpatient (N=201). Inpatients typically were admitted to treatment actively using opioids and had completed withdrawal from opioids before study entry. Outpatients typically presented already abstinent for varying periods of time.One month after randomization, relapse rates on TAU by setting were: short-term inpatient: 63%; long term inpatient: 14%; outpatient: 28%. On XR-NTX relapse rates after one month were low (12%) across all three settings. At the end of the 6 month trial, relapse rates on TAU were high across all treatment-initiation settings (short term inpatient 77%; long term inpatient 59%; outpatient 61%), while XR-NTX exerted a modest protective effect against relapse across settings (short term inpatient: 59%; long term inpatient 46%; outpatient 38%).Short term inpatient treatment is associated with a high rate of relapse among patients with opioid use disorder. These findings support the recommendation that medically supervised withdrawal from opioids should be followed by medication assisted treatment.

The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.

Buprenorphine, an effective treatment for opioid use disorder (OUD), remains underutilized in many U.S. jails and prisons. However, use of non-prescribed (i.e., diverted) buprenorphine has been reported in these settings. The current study examined non-prescribed buprenorphine use experiences in correctional and community contexts. The study conducted face-to-face interviews with 300 adults with OUD/opioid misuse and recent incarceration, recruited in Baltimore, MD, and New York, NY (n = 150 each). Illicit/non-prescribed opioid use during incarceration was reported by 63% of participants; 39% reported non-prescribed buprenorphine. Non-prescribed buprenorphine was considered the most widely available opioid in jails/prisons in both states (81% reported "very" or "somewhat" easy to get). The average price of non-prescribed buprenorphine in jail/prison was ~10× higher than in the community (p < 0.001). Participants were more likely to endorse getting high/mood alteration as reasons for using non-prescribed buprenorphine during incarceration, but tended to ascribe therapeutic motives to use in the community (e.g., self-treatment; p < 0.001). Multivariable logistic regression analyses showed that different individual-level characteristics were associated with history of non-prescribed buprenorphine use during incarceration and in the community. Use of non-prescribed buprenorphine during incarceration was associated with younger age (p = 0.006) and longer incarceration history (p < 0.001), while use of non-prescribed buprenorphine in the community was associated with MD recruitment site (p = 0.001), not being married (p < 0.001), prior buprenorphine treatment experience (p < 0.001), and housing situation (p = 0.01). These findings suggest that different dynamics and demand characteristics underlie the use of non-prescribed buprenorphine in community and incarceration contexts, with implications for efforts to expand OUD treatment in correctional settings.

Issues. Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence. Approach. Studies were required to evaluate the use of text messaging as an intervention for persons who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criterion for a diagnosis of illicit drug and/or alcohol dependence. Authors searched for articles published to date in MEDLINE (pubmed.gov), the Cochrane Library, EMBASE, CINAHL, Google Scholar and PsychINFO. Key Findings. Eleven articles met the search criteria for this review and support the acceptability and feasibility of text messaging interventions for addressing illicit drug and alcohol dependence. Most studies demonstrated improved clinical outcomes, medication adherence and engagement with peer support groups. Text messaging interventions also intervened on multiple therapeutic targets such as appointment attendance, motivation, self-efficacy, relapse prevention and social support. Implications. Suggestions for future research are described, including intervention design features, clinician contact, privacy measures and integration of behaviour change theories. Conclusion. Text messaging interventions offer a feasible platform to address a range of substances (i.e. alcohol, methamphetamine, heroin and alcohol), and there is increasing evidence supporting further larger-scale studies. [Tofighi B, Nicholson JM, McNeely J, Muench F, Lee JD. Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. Drug Alcohol Rev 2017;00:000-000]

Background/Aims Criminal-justice-involved persons are highly susceptible to opioid relapse and overdose-related deaths. In a recent randomized trial, we demonstrated the effectiveness of extended release naltrexone (XR-NTX; Vivitrol®) in preventing opioid relapse among criminal-justice-involved U.S. adults with a history of opioid use disorder. The cost of XR-NTX may be a significant barrier to adoption. Thus, it is important to account for improved quality of life, and downstream cost-offsets. Our aims were to (1) estimate the incremental cost per quality-adjusted life-year (QALY) gained for XR-NTX versus treatment as usual (TAU), and evaluate it relative to generally-accepted value thresholds; and (2) estimate the incremental cost per additional year of opioid abstinence. Design Economic evaluation of the aforementioned trial from the taxpayer perspective. Participants were randomized to 25 weeks of XR-NTX injections or TAU; follow-up occurred at 52 and 78 weeks. Setting Five study sites in the U.S. Northeast corridor. Participants 308 participants were randomized to XR-NTX (n = 153) or TAU (n = 155). Measurements Incremental costs relative to incremental economic and clinical effectiveness measures, QALYs and abstinent-years, respectively. Findings The 25-week cost-per-QALY and -abstinent-year figures were $162,150 and $46,329, respectively. The 78-week figures were $76,400/QALY and $16,371/abstinent-year. At 25 weeks, we can be 10% certain that XR-NTX is cost-effective at a value threshold of $100,000/QALY, and 62% certain at $200,000/QALY. At 78 weeks, the cost-effectiveness probabilities are 59% at $100,000/QALY and 76% at $200,000/QALY. We can be 95% confident that the intervention would be considered a “good-value” at $90,000/abstinent-year at 25 weeks, and $500/abstinent-year at 78 weeks. Conclusions While extended release naltrexone appears to be effective in increasing both quality-adjusted life-years (QALYs) and abstinence, it does not appear to be cost-effective using generally-accepted value thresholds for QALYs, due to the high price of the injection.

Buprenorphine office-based opioid maintenance is an increasingly common form of treatment for opioid use disorders. However, total prescribing has not kept pace with the current opioid and overdose epidemic and access remains scarce among the underserved. This study sought to assess current provider attitudes and clinical practices among a targeted sample of primarily New York City public sector buprenorphine prescribers. A cross-sectional online survey purposefully sampled buprenorphine prescribers in NYC with a focus on those serving Medicaid and uninsured patient populations. Expert review of local provider networks, snowball referrals, and in-person networking generated an email list, which received a survey link. A brief 25-question instrument queried provider and practice demographics, prescribing practices including induction approaches and attitudes regarding common hot topics (e.g., buprenorphine diversion, prescriber patient limits, insurance issues, ancillary treatments). Of 132 email invitations, N=72 respondents completed (n=64) or partially completed (n=8) the survey between January and April 2016. Most (79%) were Medicaid providers in non-psychiatric specialties (72%), working in a hospital-based or community general practice (51%), and board-certified in addiction medicine or psychiatry (58%). Practice sizes were generally 100 patients or fewer (71%); many providers (64%) individually prescribed buprenorphine

We examined technology use patterns (e.g., mobile phone and computer ownership, text messaging, internet access) and preferences for adopting health information technologies to optimize office-based treatment for substance use disorders, HIV, and Hepatitis C virus (HCV) infection. Surveys were administered to patients enrolled in inpatient detoxification program in a publicly-funded tertiary referral center. Most reported mobile phone ownership (86%) and described high rates of mobile phone (3.3) and phone number (2.6) turnover in the preceding year. Internet access was reported on a daily (52%) or weekly basis (22%). Most participants were amenable to receiving text message-based informational content (i.e., medications, support groups, treatment programs) pertaining to substance use disorders (79%), HIV (50%), and HCV care (58%). Respondents reporting less than high school education and past year incarcerated elicited higher favorability in adopting smartphone apps to facilitate peer sharing of HIV-HCV related content. Results suggest high favorability for adopting health information technologies to enhance office-based treatment for substance use disorders, HIV, and HCV, particularly among vulnerable patient sub-groups.

Project Extension for Community Healthcare Outcomes (Project ECHO) offers an innovative and low-cost approach to enhancing the management of complex conditions among primary care providers. The NYC Health + Hospitals Buprenorphine ECHO (H + H ECHO) program offers primary care providers (PCPs) training and support in managing opioid use disorder (OUD). This exploratory study assessed the feasibility of a 16-session video conferencing platform led by Addiction Medicine experts in improving addiction knowledge, perceived self-efficacy, and buprenorphine prescribing among PCPs located in 17 publicly-funded ambulatory care clinics. A pre- and post-training survey assessed changes in knowledge and self-efficacy. Buprenorphine prescribing patterns were also captured pre-post training. Training sessions consisted of a review of the agenda by the H + H ECHO hub team, 15–30 min didactic lectures led by specialists, followed by a patient case presentation. Participants attended an average of 9 lectures (range, 1–15 sessions) and 53% of trainees attended at least 10 of the 16 sessions. Perceived self-efficacy improved post-H + H ECHO (73.2%) versus pre-training survey results (58.1%). There were minimal increases in knowledge post-training (58.4%) versus pre-training (51.4%). Only three additional providers reported prescribing Buprenorphine post-training (n = 10) versus pre-training (n = 7). Suggestions for improving H + H ECHO included trainings addressing stigma, administrative support, improved referrals to office-based opioid treatment (OBOT), integration of non-physician staff (i.e., case management, social work), and combining multimodal learning strategies (i.e., podcasts, web-based modules) with videoconferencing. This study demonstrates the feasibility of H + H ECHO among PCPs in publicly-funded clinics and improvements in self-efficacy. Studies are needed to identify alternative strategies to improve knowledge and prescribing of buprenorphine post-H + H ECHO.

BACKGROUND: Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders. METHODS: This pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. ONTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (< 2 drinks/day, men; < 1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120). RESULTS: We describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported. CONCLUSIONS: XR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX’s treatment and cost effectiveness relative to oral naltrexone.

Background Technology-based interventions offer a practical, low-cost, and scalable approach to optimize the treatment of substance use disorders (SUDs) and related comorbidities (HIV, hepatitis C infection). This study assessed technology use patterns (mobile phones, desktop computers, internet, social media) among adults enrolled in inpatient detoxification treatment. Methods A 49-item, quantitative and qualitative semi-structured survey assessed for demographic characteristics, technology use patterns (ie, mobile phone, text messaging [TM], smart phone applications, desktop computer, internet, and social media use), privacy concerns, and barriers to technology use. We used multivariate logistic regression models to assess the association between respondent demographic and clinical characteristics and their routine use of technologies. Results Two hundred and six participants completed the survey. Nearly all participants reported mobile phone ownership (86%). Popular mobile phone features included TM (96%), web-browsers (81%), and accessing social media (61%). There was high mobile phone (3.3 ± 2.98) and phone number (2.6 ± 2.36) turnover in the preceding 12 months. Nearly half described daily or weekly access to desktop computers (48%) and most reported internet access (67%). Increased smartphone ownership was associated with higher education status (P = 0.022) and homeless respondents were less likely to report mobile phone ownership (P = 0.010) compared to participants with any housing status (ie, own apartment, residing with friends, family, or in a halfway house). Internet search engines were used by some participants (39.4%, 71/180) to locate 12 step support group meetings (37%), inpatient detoxification programs (35%), short- or long-term rehabilitation programs (32%), and outpatient treatment programs (4%). Conclusions Technology use patterns among this hard-to-reach sample of inpatient detoxification respondents suggest high rates of mobile phone ownership, TM use, and moderate use of technology to facilitate linkage to addiction treatment services.

Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder.To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone.Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs.Study instruments.Adults with opioid use disorder.24-week intervention with an additional 12 weeks of observation.Health care sector and societal.Buprenorphine-naloxone and extended-release naltrexone.Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids.Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective.The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation.Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs.Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone.National Institute on Drug Abuse, National Institutes of Health.

The acceptability and clinical impact of a web-based intervention among patients entering addiction treatment who lack recent internet access are unclear. This secondary analysis of a national multisite treatment study (NIDA Clinical Trials Network-0044) assessed for acceptability and clinical impact of a web-based psychosocial intervention among participants enrolling in community-based, outpatient addiction treatment programs. Participants were randomly assigned to 12 weeks of a web-based therapeutic education system (TES) based on the community reinforcement approach plus contingency management versus treatment as usual (TAU). Demographic and clinical characteristics, and treatment outcomes were compared among participants with recent internet access in the 90 days preceding enrollment (N = 374) and without internet access (N = 133). Primary outcome variables included (1) acceptability of TES (i.e., module completion; acceptability of web-based intervention) and (2) clinical impact (i.e., self-reported abstinence confirmed by urine drug/breath alcohol tests; retention measured as time to dropout). Internet use was common (74 %) and was more likely among younger (18–49 years old) participants and those who completed high school (p

The deployment of health information technologies promises to optimize clinical outcomes for populations with substance use disorders. Electronic health records, web-based counseling interventions, and mobile phone applications enhance the delivery of evidence-based behavioral and pharmacological treatments, with minimal burden to clinical personnel, infrastructure, and work flows. This clinical case shares a recent experience utilizing mobile phone text messaging between an office-based buprenorphine provider in a safety net ambulatory clinic and a patient seeking buprenorphine treatment for opioid use disorder. The case highlights the use of text message-based physician-patient communication to facilitate unobserved "home" induction onto buprenorphine.

Introduction: Online drug markets and social media are facilitating the spread of information and sale of illicit substances. Online sites, such as Craigslist and Bluelight, underscore an emerging shift in contemporary drug consumerism.Case Descriptions: We report on two cases. Case 1 is a 42-year-old male with a history of heroin-use disorder, presented for an initial visit to an office-based buprenorphine program, and reported having acquired heroin from Craigslist. Despite several harrowing experiences, Craigslist remained Patient 1’s primary method of purchasing heroin during a 14-month period. Craigslist ads also redirected the patient to the web site Bluelight, which facilitated access to updated information on open-air drug markets in New York City. Case 2 is a 23-year-old male, who was admitted to inpatient detoxification and utilized the site for the sale of heroin in order to fund his own use of heroin. He sold heroin via Craigslist for 1 year until his arrest, noting undeterred advertis...

Objective To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients. Methods We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes. Results We identified two subpopulations: HRQoL "pharmacotherapy responsive" (82.3 %) and HRQoL "characteristic sensitive" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics. Conclusion Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.

BACKGROUND Smoking remains a major public health burden among persons with opioid and/or alcohol use disorder yet preferences for technology assisted smoking cessation strategies remain largely unknown among this population. OBJECTIVE Assess smoking patterns and preferences for adopting technology-based interventions targeting smoking among individuals with opioid and/or alcohol use disorder. METHODS A 48-item semi-structured survey was conducted among inpatient detoxification program patients eliciting demographic and clinical characteristics, smoking profile, technology use patterns, and preferences for adopting technology-based smoking cessation interventions. Multivariate logistic regression models further evaluated the association between participant demographic and clinical characteristics and technology preferences. RESULTS Participants were mostly male (91%), unemployed or dependent on public assistance (68%), and admitted for detoxification for alcohol (47%), heroin (31%), or both alcohol and heroin (22%). Past 30-day smoking was reported by 78% of the sample, and 60% reported at least one quit attempt in the past year. Mobile phone ownership was common (89%); with an average past-year turnover of 4 mobile phones and 3 phone numbers. Computer ownership was low (28%) and one third reported daily internet use (34%). Telephone (41%) and text message-based interventions (40%) were the most popular technology-based intervention to facilitate smoking cessation. CONCLUSIONS Despite concurrent AUD-OUD, most had attempted to quit smoking in the last year and preferred telephone- and text message-based interventions to facilitate smoking cessation. However, high turnover of mobile phones, phone numbers, and limited access to computers pose barriers to dissemination of technology-based smoking cessation interventions in this vulnerable population. CLINICALTRIAL K23DA042140-01A1

Background Criminal justice involved (CJS) populations with opioid use disorder (OUD) have high rates of relapse, future arrests, and death upon release. While medication for OUD (MOUD) reduces opioid relapse, concerns regarding diversion and stigma limit treatment in CJS populations. Extended release naltrexone (XR-NTX), as an opioid antagonist, may be more acceptable to CJS administrators. However, the impact of XR-NTX on criminal recidivism remains unknown. Methods Arrest data from a published randomized trial comparing XR-NTX to treatment as usual (TAU) was captured by self-report and official state arrest records. Comparisons of future arrests, time to first arrest and total number of arrests were performed using chi square tests and multivariable generalized regression models. Secondary outcomes explored differences in arrests by type and severity of crime, use of opioid and other drugs, and study phase. Results Of 308 participants randomized, 300 had arrest data. The incidence of arrests did not differ between XR-NTX (47.6%) and TAU (42.5%) participants. (ChiSq p = 0.37). Additionally, there was no significant difference in time to first arrest (adjusted HR 1.35, CI 0.96–1.89) and number of arrests per participant (adjusted IR 1.33, CI 0.78–2.27). Controlling for gender, age, previous criminal activity, and use of non-opioid drugs, logistic regression demonstrated no significant difference in incidence of arrests between groups (adjusted OR 1.38, 95% CI 0.85–2.22). Conclusions We detected no significant difference in arrests between CJS participants with OUD randomized to XR-NTX or TAU. Despite its efficacy in reducing opioid use, XR-NTX alone may be insufficient to reduce criminal recidivism.

Background and Aims Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid-dependent male adults leaving a large urban jail. Design Eight-week, proof-of-concept, open-label, non-blinded randomized effectiveness trial. Setting New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA. Participants From January 2010 to July 2013, 34 opioid-dependent adult males with no stated interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR-NTX (n = 17) versus no medication (n = 17) within one week prior to jail release. Intervention XR-NTX (Vivitrol®; Alkermes Inc.), a long-acting injectable mu opioid receptor antagonist. Measures The primary intent-to-treat outcome was post-release opioid relapse at week 4, defined as ≥10 days of opioid misuse by self-report and urine toxicologies. Secondary outcomes were proportion of urine samples negative for opioids and rates of opioid abstinence, intravenous drug use (IVDU), cocaine use, community treatment participation, re-incarceration and overdose. Findings Acceptance of XR-NTX was high; 15 of 17 initiated treatment. Rates of the primary outcome of week 4 opioid relapse were lower among XR-NTX participants: 38 versus 88% [P

Background Extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. Methods This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of ≥ 10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use. Results We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed. Conclusions XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898 Language: en

Extended-release naltrexone (XR-NTX), an opioid antagonist, and sublingual buprenorphine-naloxone (BUP-NX), a partial opioid agonist, are pharmacologically and conceptually distinct interventions to prevent opioid relapse. We aimed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX.We initiated this 24 week, open-label, randomised controlled, comparative effectiveness trial at eight US community-based inpatient services and followed up participants as outpatients. Participants were 18 years or older, had Diagnostic and Statistical Manual of Mental Disorders-5 opioid use disorder, and had used non-prescribed opioids in the past 30 days. We stratified participants by treatment site and opioid use severity and used a web-based permuted block design with random equally weighted block sizes of four and six for randomisation (1:1) to receive XR-NTX or BUP-NX. XR-NTX was monthly intramuscular injections (Vivitrol; Alkermes) and BUP-NX was daily self-administered buprenorphine-naloxone sublingual film (Suboxone; Indivior). The primary outcome was opioid relapse-free survival during 24 weeks of outpatient treatment. Relapse was 4 consecutive weeks of any non-study opioid use by urine toxicology or self-report, or 7 consecutive days of self-reported use. This trial is registered with ClinicalTrials.gov, NCT02032433.Between Jan 30, 2014, and May 25, 2016, we randomly assigned 570 participants to receive XR-NTX (n=283) or BUP-NX (n=287). The last follow-up visit was Jan 31, 2017. As expected, XR-NTX had a substantial induction hurdle: fewer participants successfully initiated XR-NTX (204 [72%] of 283) than BUP-NX (270 [94%] of 287; p0·0001). Among all participants who were randomly assigned (intention-to-treat population, n=570) 24 week relapse events were greater for XR-NTX (185 [65%] of 283) than for BUP-NX (163 [57%] of 287; hazard ratio [HR] 1·36, 95% CI 1·10-1·68), most or all of this difference accounted for by early relapse in nearly all (70 [89%] of 79) XR-NTX induction failures. Among participants successfully inducted (per-protocol population, n=474), 24 week relapse events were similar across study groups (p=0·44). Opioid-negative urine samples (p0·0001) and opioid-abstinent days (p0·0001) favoured BUP-NX compared with XR-NTX among the intention-to-treat population, but were similar across study groups among the per-protocol population. Self-reported opioid craving was initially less with XR-NTX than with BUP-NX (p=0·0012), then converged by week 24 (p=0·20). With the exception of mild-to-moderate XR-NTX injection site reactions, treatment-emergent adverse events including overdose did not differ between treatment groups. Five fatal overdoses occurred (two in the XR-NTX group and three in the BUP-NX group).In this population it is more difficult to initiate patients to XR-NTX than BUP-NX, and this negatively affected overall relapse. However, once initiated, both medications were equally safe and effective. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications.NIDA Clinical Trials Network.