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Introduction: Among women at risk for alcohol-exposed pregnancies (AEP), smoking tobacco may be associated with increased severity of alcohol use, and risk for tobacco-exposed and other substance-exposed pregnancies (TEPs/SEPs). Our secondary data analysis of the 'CHOICES Plus' intervention trial explored AEP and SEP risk by smoking status. Material and Methods: Eligible women (N=261) were recruited from 12 primary care clinics in a public healthcare system, not pregnant, aged 18–44 years, drinking >3 drinks/ day or >7 drinks/week, sexually active, and not using effective contraception. We compared women who did and did not smoke tobacco on alcohol and drug severity, and psychological distress (e.g. anxiety) at baseline. Results: Participants were primarily Hispanic (47.1%) or non-Hispanic Black (41.8%) and reported incomes <000/year (69.3%). Tobacco smoking prevalence was 45.2%. Compared to non-smokers, those who smoked drank more days/week (mean=3.3, SD=2.0 vs mean=2.7, SD=1.8, p<0.01), had higher alcohol use disorders identification test (AUDIT) scores (mean=12.1, SD=7.6 vs mean=9.8, SD=7.1, p<0.05), were more likely to report current drug use (66.1% vs 48.3%, p<0.01), and had a greater number of (lifetime) drugs used (mean=3.0, SD=2.0 vs mean=2.0, SD=1.5 days, p<0.0001). Also, those who smoked reported greater levels of anxiety (mean=5.9, SD=5.6 vs mean=4.5, SD=4.9, p<0.05), lower confidence to not drink (mean=2.8, SD=0.8 vs mean=3.1, SD=1.0, p<0.01), lower confidence to reduce risky drinking (mean=6.3, SD=3.1 vs mean=7.3, SD=2.8, p<0.0001), greater drinking temptations (mean=3.0, SD=0.9 vs mean=2.6, SD=0.9, p<0.01), and, yet greater readiness to reduce alcohol use (mean=6.2, SD=3.0 vs mean=5.2, SD=3.0, p<0.05). Conclusions: Women who drink and smoke may have the highest AEP, TEP, and other SEP risk. Primary care providers should screen for alcohol and tobacco co-use and provide brief intervention and/or treatment referral. CLINICAL TRIAL REGISTRATION: The study was registered on the official website of ClinicalTrials.gov IDENTIFIER: ID NCT01032772 /0.01),> [ABSTRACT FROM AUTHOR]

Prescribed opioids are a mainstay pain treatment after traumatic injury, but a subgroup of patients may be at risk for continued opioid use. We evaluated the predictive utility of a traditional screening tool, the Opioid Risk Tool (ORT), and two other measures: average in-hospital milligram morphine equivalents (MME) per day and an assessment of opioid demand in predicting pain outcomes. Assessments of pain-related outcomes (pain intensity, interference, injury-related stress, and need for additional pain treatment) were administered at 2 weeks and 12 months post-discharge in a sample of 34 patients hospitalized for traumatic injury. Bayesian linear models were used to evaluate changes in responses over time as a function of predictors. High-risk ORT, higher MME per day, and greater opioid demand predicted less change in outcomes over time. This report provides first evidence that malleable factors of opioid and opioid demand have utility in predicting pain outcomes following traumatic injury. [ABSTRACT FROM AUTHOR]

Background: The response time speed-accuracy trade-off (SATO) is an established index of information processing ability, but rarely examined as a variable in association with treatment of substance use disorder (SUD).Aim: The purpose of this study was to test baseline information-processing ability differences between individuals who respond to treatment for cocaine use disorder v. those who do not.Methods: Eighty patients enrolled in a clinical trial for cocaine use disorder completed a baseline drug-specific eye-tracking (anti-saccade) assessment prior to treatment, which included trials with both cocaine-related and neutral stimuli. SATO functions were computed for treatment responders v. non-responders.Results: Unexpectedly, responders demonstrated statistically different SATO functions, showing poorer accuracy when executing faster response times. This difference was present on trials that presented cocaine stimuli only.Conclusions: SATO during performance of an eye-movement task may be useful for predicting differential response to substance use disorder treatment. However, in the present study, results were specific to cocaine cues rather than an overall SATO performance decrement. [ABSTRACT FROM AUTHOR]

Introduction: Thirdhand smoke (THS) residue results from secondhand smoke, and is emerging as a distinct public health hazard, particularly for medically fragile pediatric patients living with smokers. THS is difficult to remove and readily reacts with other pollutants to form carcinogens and ultrafine particles. This study investigated THS found in homes of high-risk infants admitted to a neonatal intensive care unit and their association with characteristics (eg, number of household smokers) hypothesized to influence THS.Methods: Baseline data from 141 hospitalized infants' homes were analyzed, along with follow-up data (n = 22) to explore household smoking characteristics and THS changes in response to indoor smoking ban policies.Results: Households with an indoor ban, in which not more than 10 cigarettes/d were smoked, had the lowest levels of THS contamination compared to homes with no ban (P < .001) and compared to homes with an indoor ban in which greater numbers of cigarettes were smoked (P < .001). Importantly, homes with an indoor ban in which at least 11 cigarettes/d were smoked were not different from homes without a ban. The follow-up sample of 22 homes provided initial evidence indicating that, unless a ban was implemented, THS levels in homes continued to increase over time.Conclusions: Preliminary longitudinal data suggest that THS may continue to accumulate in homes over time and household smoking bans may be protective. However, for homes with high occupant smoking levels, banning indoor smoking may not be fully adequate to protect children from THS. Unless smoking is reduced and bans are implemented, medically fragile children will be exposed to the dangers of THS. [ABSTRACT FROM AUTHOR]

Background: Studies reveal that electronic cigarette (e-cigarette) and hookah use are increasing among adolescents and young adults. However, the long-term health effects are unknown, especially with regards to pregnancy. Because of the increased use in women of reproductive age, and the unknown long-term health risks, our primary objectives were to determine the perceived risks of e-cigarette and hookah use in pregnancy, and learn common colloquial terms associated with e-cigarettes. Furthermore, we sought to determine if there is a stigma associated with e-cigarette use in pregnancy.Methods: Eleven focus groups including 87 participants were conducted immediately following regularly scheduled CenteringPregnancy® prenatal care with women at three different clinics in the greater Houston area. A minimum of two facilitators led the groups, using ten lead-in prompts, with Spanish translation as necessary. Facilitators took notes which were compared immediately following each group discussion and each group was audio recorded and transcribed. Three facilitators utilized NVivo 9.0 software to organize the transcribed data into nodes to identify major themes. To increase rigor, transcripts were further analyzed by two obstetricians who were instructed to find the major themes.Results: Analyses revealed contradicting themes concerning e-cigarette use. In general, e-cigarettes were perceived as safer alternatives to regular tobacco cigarettes, especially if used as smoking cessation devices. A major theme is that use in pregnancy is harmful to the fetus. However, it was perceived that use for smoking cessation in pregnancy may have fewer side effects. We found that a common term for e-cigarettes is "Blu." In our discussion of hookah use, participants perceived use as popular among teenagers and that use in pregnancy is dangerous for the fetus.Conclusions: Although a strong theme emerged against hookah use, we found contradicting themes in our discussions on e-cigarette use in pregnancy. It is possible that e-cigarette use will not carry the same stigma as regular cigarette smoking in pregnancy. In addition, the impression of e-cigarettes as a healthier alternative to smoking may influence use in pregnancy. Clinicians need to be prepared for questions of e-cigarette safety and efficacy as smoking cessation devices from their pregnant patients who smoke, and women who smoke and are planning to become pregnant. [ABSTRACT FROM AUTHOR]

Objective The aim of the study is to conduct an initial pilot trial evaluating the feasibility, safety, and efficacy of bupropion for smoking cessation in pregnancy. Study Design A randomized, double-blind, parallel-group pilot study of bupropion versus placebo with 50 pregnant smokers was planned. Eligibility criteria were restrictive (e.g., 14-26 weeks' gestation; no psychiatric conditions or medications) due to the unknown safety, tolerability, and side effect profile of bupropion in pregnancy. Bayesian analyses were planned to provide probability of benefit. Results Significant challenges were encountered with regard to trial feasibility. Of 820 women screened, 112 were current smokers, but only 11 women were eligible and consented to participate in the study. Excluded women most often had a psychiatric disorder (23%); were outside the gestational range (14%); or declined to participate (11%). Conclusions This initial attempt to evaluate bupropion for smoking cessation during pregnancy will inform future trial methodology. Because of the unknown safety profile, conservative eligibility criteria were used and resulted in a large portion of this high-risk, low-income smoker population being excluded from the trial, raising questions regarding broad applicability, and highlighting the need to balance patient safety and trial feasibility. Large multisite studies will likely be needed to conduct definitive pharmacotherapy studies. [ABSTRACT FROM AUTHOR]

Abstract: Treatment retention is of paramount importance in cocaine treatment research as treatment completion rates are often 50% or less. Failure to retain cocaine patients in treatment has both significant research and clinical implications. In this paper we qualitatively and quantitatively demonstrate the inconsistency found across analyses of retention predictors in order to highlight the problem. First, a qualitative review of the published literature was undertaken to identify the frequency of predictors studied and their relations to treatment retention. Second, an empirical demonstration of predictor stability was conducted by testing a common set of variables across three similar 12-week cocaine clinical trials conducted by the same investigators in the same research clinic within a five-year period. Results of the literature review indicated inconsistently selected variables of convenience, widely varying statistical procedures, and discrepant findings of significance. Further, quantitative analyses resulted in discrepancies in variables identified as significant predictors of retention among the three studies. Potential sources of heterogeneity affecting the consistency of findings across studies and recommendations to improve the validity and generalizability of predictor findings in future studies are proposed. [Copyright &y& Elsevier]

Introduction: The National Drug Abuse Treatment Clinical Trials Network (CTN) was initiated by the National Institute on Drug Abuse (NIDA) in 2000 with the aim of improving substance use treatment and reducing the time between the discovery of effective treatments and their implementation into clinical practice. While initial trials were conducted almost exclusively in specialty addiction treatment settings, the CTN began evolving strategically in 2010 to conduct research in general medical settings, including healthcare systems, primary care settings, emergency departments, and pharmacies, to broaden impact. The advantages of a research network like the CTN is not only the collective content expertise that investigators contribute to the network, but the collective experience gained by conducting studies in the network and then applying those lessons to future studies.Objective: To summarize trial implementation challenges encountered, and the process by which solutions were identified and implemented, within one of the last early-phase CTN Stage II behavioral intervention studies conducted in a specialty addiction treatment setting.Method and Results: We describe the implementation of the CTN-0037 STimulant Reduction Intervention using Dosed Exercise (STRIDE) trial. Issues encountered during study implementation are categorized into four major areas, described in terms useful to future study teams: 1) study team infrastructure challenges, 2) participant- and site- level challenges, 3) intervention-related challenges, and 4) longitudinal study design challenges. Potential consequences of identified problems and the solutions developed to manage these problems are discussed within the context of these four areas. We propose how to extend these implementation lessons and apply them in other healthcare settings to expand the CTN.Conclusions: Effective study management allows for flexible, collaborative solutions to expected and unexpected obstacles to study success. Implementation strategies derived from the first 15 to 20 years of CTN studies are a result of working with providers and participants, and the ongoing collaboration among CTN investigators and network staff. Timely identification and response to problems during study implementation are critical to the success of a trial, regardless of its design. We believe a collaborative approach to identifying and responding to study implementation challenges will increase the likelihood of successful adoption of relevant, efficacious interventions. As the CTN continues to expand, the wealth of successful trial implementation strategies developed during the first 20 years of the CTN need to be applied and adapted to studies in broader network settings, and considered in conjunction with more formalized implementation science processes that are currently available. [ABSTRACT FROM AUTHOR]

Background: Missing data in substance use disorder (SUD) research pose a significant threat to internal validity. Participants terminate involvement or become less likely to attend intervention and research visits for many reasons, which should be addressed prior to becoming problematic. During a 9-month study targeting stimulant abuse, early dropouts and participant reported attendance barriers led to implementing a structured, pre-randomization protocol with participants about retention and solution-focused strategies (the "Fireside Chat"). Our aim is to outline this approach and present data on intervention participation and research visit attendance after implementation.Methods/design: STimulant Reduction using Dosed Exercise (STRIDE) was a two-arm, multisite randomized clinical trial testing treatment-as-usual for stimulant abuse/dependence augmented by Exercise or Health Education. For both groups, study intervention visits at the site were scheduled 3/week for 12weeks followed by 1/week for 24weeks. During The Chat, research staff thoroughly reviewed participants' expectations, and barriers and solutions to retention. Fifteen participants were randomized (to Exercise or Health Education) prior to and fourteen were randomized after Chat implementation. Intervention and monthly follow-up attendance (before and after implementation) were compared at the site (N=29) that developed and rigorously implemented The Chat.Results: Individuals who participated in The Chat (n=14) attended significantly more intervention visits during weeks 1-12 (p<0.001) and weeks 13-36 (p<0.05) and attended more research visits (p<0.001).Discussion: Proactive discussion of expectations and barriers prior to randomization was associated with greater study attendance. SUD researchers should consider tailoring this approach to suit their needs. Further investigation is warranted. [ABSTRACT FROM AUTHOR]