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Screening to identify patients at risk for opioid misuse after trauma is recommended but not commonly used to guide perioperative opioid management interventions. The Multimodal Analgesic Strategies for Trauma trial demonstrated that an opioid-minimizing multimodal pain regimen reduced opioid exposure in a heterogeneous trauma patient population. Here, we assess the efficacy of the Multimodal Analgesic Strategies for Trauma multimodal pain regimen in a critical patient subgroup who screened at high risk for opioid misuse. The Multimodal Analgesic Strategies for Trauma trial compared an opioid-minimizing multimodal pain regimen (oral acetaminophen, naproxen, gabapentin, lidocaine patch, as-needed opioid) against an original multimodal pain regimen (intravenous followed by oral acetaminophen, 48-hour celecoxib and pregabalin, followed by naproxen and gabapentin, scheduled tramadol, as-needed opioid), in a randomized trial conducted from April 2018 to March 2019. A total of 631 enrolled patients were classified either as low- or high-risk via the Opioid Risk Tool. Bayesian analyses evaluated the moderating influence of Opioid Risk Tool risk (high/low) on the effect of Multimodal Analgesic Strategies for Trauma multimodal pain regimen (versus original) on opioid exposure (morphine milligram equivalents/day), opioids prescribed at discharge, and pain scores. Multimodal Analgesic Strategies for Trauma multimodal pain regimen effectively reduced morphine milligram equivalents/day in low- and high-Opioid Risk Tool risk groups. Moderation was observed for opioids at discharge and pain scores; Multimodal Analgesic Strategies for Trauma multimodal pain regimen was effective in the high-risk group only (opioids at discharge: 63% vs 77%, relative risk = 0.86, 95% Bayesian credible interval [0.66–1.08], posterior probability (relative risk <1) = 90%; pain scores: b = 3.8, 95% Bayesian credible interval [3.2–4.4] vs b = 4.0, 95% Bayesian credible interval [3.4–4.6], posterior probability (b <0) = 87%). This study is the first to show the moderating influence of opioid misuse risk on the effectiveness of an opioid-minimizing multimodal pain regimen. The Opioid Risk Tool was useful in identifying high-risk patients for whom the Multimodal Analgesic Strategies for Trauma multimodal pain regimen is recommended for perioperative pain management. [Display omitted] [ABSTRACT FROM AUTHOR]

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.addbeh.2006.06.022 Byline: Marc E. Mooney (b), Shelly L. Sayre (a)(c), Patricia S. Hokanson (a)(c), Angela L. Stotts (a)(c), Joy M. Schmitz (a)(c) Keywords: Bupropion; Medication compliance; MEMS Abstract: This study was conducted to replicate and extend initial positive findings on the usefulness of a Medication Event Monitoring System (MEMS) to assess pill-taking behavior and enhance compliance with bupropion for smoking cessation. Participants (N =55) received MEMS bottles containing bupropion-SR (150 mg) to be taken twice daily for 7 weeks. For participants randomly assigned to the Enhanced Therapy group (n =27), weekly individual smoking cessation therapy sessions included an additional 10 min of MEMS feedback and compliance enhancement counseling using CBT techniques. The Usual Care group (n =28) received weekly individual smoking cessation sessions only. Compliance outcomes included total doses taken and number of doses taken within the prescribed time interval. Results indicated significantly higher compliance over time for the Enhanced Therapy group. Smoking abstinence rates did not differ between the two groups, although results from the pooled sample analysis showed a significant association between level of medication compliance and abstinence status at treatment weeks 3 and 6. Incorporating MEMS-based compliance interventions into smoking pharmacotherapy trials is recommended. Author Affiliation: (a) University of Texas, Houston Substance Abuse Research Center, United States (b) Transdisciplinary Tobacco Use Research Center, University of Minnesota, Department of Psychiatry, Minneapolis, MN, United States (c) Department of Psychiatry and Behavioral Sciences, University of Texas, Houston, United States

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.addbeh.2006.03.044 Byline: Ayesha Chawdhary (a)(b), Shelly L. Sayre (a)(b), Charles Green (a)(b), Joy M. Schmitz (a)(b), John Grabowski (a)(b), Marc E. Mooney (c) Keywords: Attrition; Cocaine; Impulsivity; Prognostic modeling Abstract: A substantial amount of attrition in cocaine dependence treatment studies occurs between the initial telephone contact and the first evaluative clinic visit. While decreasing the wait to first visit can significantly reduce pre-intake attrition (PIA), little is known about other factors that moderate delay tolerance for first clinic visit. The current report uses data from 833 subjects who completed a first-contact telephone interview prior to an intake evaluation visit for cocaine use treatment research. Hierarchical logistic regression was used to assess three successive models to predict PIA, with the most inclusive model testing interactions between delay interval and seven predictors: age, gender, treatment motivation, recency of cocaine, alcohol, and tobacco use, and self-reported depression. Consistent with previous reports, greater delay to first clinic visit predicted PIA. However, no evidence for the moderating role of the selected factors was found. Overall, the utility of the logistic models, built on basic demographic and psychiatric factors, was poor, as evaluated using receiver-operator characteristic curves. Alternative factors must be examined to identify predictors that will increase probability of initial enrolment in cocaine-dependence clinical trials. Author Affiliation: (a) University of Texas Health Science Center-Houston Substance Abuse Research Center, USA (b) Department of Psychiatry and Behavioral Sciences, University of Texas, Houston, USA (c) Department of Psychiatry, University of Minnesota, Minneapolis, USA

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.addbeh.2006.02.004 Byline: Adam M. Leventhal (a)(b), Joy M. Schmitz (b) Keywords: Expectancies; Developmental psychopathology; Risk factor; Substance abuse Abstract: While a variety of risk factors for substance abuse have been identified, the psychological mechanisms underlying the transmission of risk is unclear based on studies using traditional risk-outcome research designs. The present paper identifies drug use outcome expectancies as a common etiological mechanism involved in substance abuse risk. Existing literature findings are reviewed and integrated according to an interactional-transformational (IT) model of developmental psychopathology. This model identifies the preliminary (mediating) and secondary (moderating) role of drug expectancies as important operations involved in the development of substance use patterns. Advantages of the IT model over traditional trait-based or environmental models are discussed, along with implications for intervention and future research. Author Affiliation: (a) Department of Psychology, University of Houston, Houston, TX 77204-5022, USA (b) Department of Psychiatry and Behavioral Sciences, The University of Texas-Houston, Houston, TX, USA

Relapse has gained prominence as theoretically sound approach for substance-abuse treatment. Several cocaine-dependent respondence were assessed to investigate the role of treatment modality in relapse prevention treatment and to compare the effectiveness of group versus individual therapy. The study reveals that although both individual and group treatments possess certain unique features that might enhance client's response to relapse prevention, group therapy proves to be less expensive than individual therapy.

Results of two preliminary studies examining the efficacy of the contingency management procedure (shaping) on decreasing cocaine use and increasing compliance with the prescribed medical regimen in two high-risk cocaine-dependent population, tuberculin-exposed patients and pregnant women, are described. Monetary reinforcers were effective in reducing cocaine consumption.

A within-subjects study of five cigarette smoking methadone maintenance patients revealed that monetary incentives had minimal effects in mitigating their carbon monoxide intake levels. This result has important implications in shaping contingency management procedures in smoking cessation programs.

A study of cocaine-dependent pregnant women reveals that those who received 'baseline' drug treatment were more successful in the cessation of cocaine when compared to those taking 'intensive' drug treatment. Pregnant women taking 'baseline' treatment enjoy a better success rate because of their decision to abstain from cocaine prior to starting treatment and due to their concern for the baby. Pregnant women taking 'intensive' treatment require more time to stop cocaine intake.

The study assessed the impact of motivational interviewing (MI) intervention on transtheoretical (TTM)-based mechanisms of change in low-income pregnant smokers. Repeated measures analyses indicate that relative to usual care (UC), pregnant smokers who received MI reported a greater increase in confidence to abstain from smoking, a decrease in temptation to smoke, and a decrease in level of depression.

A survey was conducted to evaluate the recruitment methods and the initial screening processes used in outpatient treatment clinical trails for cocaine and alcohol nicotine treatment. Some of the implications of these findings, and recommendations for developing program recruitment and screening methods are described.

Abstract Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric conditions that commonly co-occur. No preferred, evidence-based treatments for PTSD/SUD comorbidity are presently available. Promising integrated treatments have combined prolonged exposure therapy with cognitive-behavioral relapse prevention therapy for SUD. We describe a case study that showcases a novel, integrated cognitive-behavioral treatment approach for PTSD/SUD, entitled Treatment of Integrated Posttraumatic Stress and Substance Use (TIPSS). The TIPSS program integrates cognitive processing therapy with cognitive-behavioral therapy for SUD for the treatment of co-occurring PTSD/SUD. The present case report, based upon a woman with PTSD comorbid with both cocaine and alcohol dependence, demonstrates that TIPSS has the potential to effectively reduce PTSD symptoms as well as substance use. Highlights • This case study showcases a novel, integrated cognitive-behavioral treatment approach for posttraumatic stress and substance use disorders. • Novel approach is entitled Treatment of Integrated Posttraumatic Stress and Substance Use (TIPSS). • TIPSS integrates cognitive processing therapy with cognitive-behavioral therapy for substance use disorder. • The treatment is comprised of 12, 60-minute individual psychotherapy sessions. • The profiled case demonstrates significant reduction in PTSD symptoms and substance use. [ABSTRACT FROM AUTHOR]

Drug addiction is a chronic, devastating, but treatable disorder. A core principle of drug addiction treatment states that no single treatment is appropriate for everyone (NIDA, 2012); treatments need to adjust based on patient characteristics and response in order to be maximally effective. For cocaine use disorders (CUD), specifically, the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures, with early cessation being a robust predictor of future abstinence. This raises two key questions for treatment development research: First, can we significantly improve initial CM response rates with targeted adjunctive interventions? Second, for individuals who fail to achieve initial abstinence with CM, is pharmacotherapy an effective augmentation strategy? This paper describes how a sequential, multiple assignment, randomized trial (SMART) design has advantages over a fixed-intervention approach when it comes to collecting data needed to answer both questions. The first aim will examine whether Acceptance and Commitment Therapy (ACT) in combination with CM increases initial abstinence response rates (i.e., 2 consecutive weeks of cocaine-negative urine screens). The second aim will examine whether ACT + CM in combination with modafinil promotes abstinence achievement in initial non-responders. Results are expected to inform how we tailor treatment of CUD to maximize outcomes. [ABSTRACT FROM AUTHOR]

Methamphetamine (MA) use is marked by high rates of comorbid tobacco smoking, which is associated with more severe drug use and worse clinical outcomes compared to single use of either drug. Research has shown the combination of naltrexone plus oral bupropion (NTX-BUP) improves smoking cessation outcomes in non-MA-using populations. In the Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) study, NTX-BUP successfully reduced MA use. Our aim in this secondary data analysis was to examine changes in cigarette smoking among the subgroup of participants reporting comorbid tobacco use in the ADAPT-2 trial. The multi-site ADAPT-2 study used a randomized, double blind, sequential parallel comparison design to evaluate treatment with extended-release injectable NTX (380 mg every 3 weeks) combined with once-daily oral extended-release BUP (450 mg/day) vs matching injectable and oral placebo in outpatients with moderate or severe MA use disorder. The study assessed smoking outcomes, based on self-reported timeline followback (TLFB) data, twice/week for 13 weeks. Of the 403 participants in the ADAPT-2 trial, 290 reported being current cigarette smokers (71.9 %). The study found significant differences (p 's < 0.0001) for each smoking outcome indicating greater change in the proportion of nonsmoking days, number of cigarettes smoked per week, and consecutive nonsmoking days, all favoring the group receiving NTX-BUP versus placebo. NTX-BUP was associated with significant reductions in self-reported cigarette smoking in the context of concurrent treatment for MA use disorder. These off-target medication effects warrant prospective investigation using biochemically confirmed measures of smoking abstinence. The development of NTX-BUP as a co-addiction treatment strategy has a potential for high public health impact. • The majority of individuals seeking treatment for methamphetamine use disorder were current cigarette smokers. • The medication combination of injectable naltrexone plus oral bupropion was effective in reducing cigarette smoking. • These medication effects warrant prospective investigation using biochemically-confirmed measures of smoking abstinence. • The development of NTX-BUP as a co-addiction treatment strategy has a potential for high public health impact. [ABSTRACT FROM AUTHOR]

Cocaine-dependent (CD) subjects show attentional bias toward cocaine-related cues, and this form of cue-reactivity may be predictive of craving and relapse. Attentional bias has previously been assessed by models that present drug-relevant stimuli and measure physiological and behavioral reactivity (often reaction time). Studies of several CNS diseases outside of substance use disorders consistently report anti-saccade deficits, suggesting a compromise in the interplay between higher-order cortical processes in voluntary eye control (i.e., anti-saccades) and reflexive saccades driven more by involuntary midbrain perceptual input (i.e., pro-saccades). Here, we describe a novel attentional-bias task developed by using measurements of saccadic eye movements in the presence of cocaine-specific stimuli, combining previously unique research domains to capitalize on their respective experimental and conceptual strengths. CD subjects ( N = 46) and healthy controls ( N = 41) were tested on blocks of pro-saccade and anti-saccade trials featuring cocaine and neutral stimuli (pictures). Analyses of eye-movement data indicated (1) greater overall anti-saccade errors in the CD group; (2) greater attentional bias in CD subjects as measured by anti-saccade errors to cocaine-specific (relative to neutral) stimuli; and (3) no differences in pro-saccade error rates. Attentional bias was correlated with scores on the obsessive–compulsive cocaine scale. The results demonstrate increased saliency and differential attentional to cocaine cues by the CD group. The assay provides a sensitive index of saccadic (visual inhibitory) control, a specific index of attentional bias to drug-relevant cues, and preliminary insight into the visual circuitry that may contribute to drug-specific cue reactivity. [ABSTRACT FROM AUTHOR]

Research into the joint action of naltrexone in combination with relapse prevention therapy for treating cocaine addiction is presented. It is suggested that naltrexone interacts with the form of therapy received.

Background: Cocaine pharmacotherapy trials are often confounded by considerable variability in baseline cocaine-use levels, obscuring possible medication efficacy. Testing the feasibility of using a prerandomization, abstinence-induction protocol, we screened three candidate medications to explore treatment response in patients who did, or did not, achieve abstinence during an extended baseline phase.Method: Eligible treatment-seeking, cocaine-dependent subjects entered a 4-week baseline period (Phase I) with high-value abstinence contingent vouchers and two motivational interviewing sessions, followed by a 12-week medication trial (Phase II) with random assignment stratified on Phase I abstinence status to (1) modafinil (400mg/d), (2) levodopa/carbidopa (800/200mg/d), (3) naltrexone (50mg/d), or (4) placebo. Treatment consisted of thrice-weekly clinic visits for urine benzoylecgonine testing and weekly cognitive behavioral therapy with contingency management targeting medication compliance.Results: Of the 118 subjects enrolled, 81 (80%) completed Phase I, with 33 (41%) achieving abstinence, defined a priori as 6 consecutive cocaine-negative urines. Tests of the interaction of each medication (active versus placebo) by baseline status (abstinent versus nonabstinent) permitted moderator effect analysis. Overall, baseline abstinence predicted better outcome. Cocaine-use outcomes for levodopa and naltrexone treatment differed as a function of Phase I abstinence status, with both medications producing benefit in nonabstinent but not baseline-abstinent subjects. There was no evidence of a moderator effect for modafinil.Conclusions: The two-phase screening trial demonstrated that subgrouping of patients with respect to baseline abstinence status is feasible and clinically useful for exploring cocaine cessation and relapse-prevention effects of candidate medications. [ABSTRACT FROM AUTHOR]

Cocaine use continues to be a significant public health problem with limited treatment options and no approved pharmacotherapies. Cognitive-behavioral therapy (CBT) remains the mainstay treatment for preventing relapse, however, people with chronic cocaine use display cognitive impairments that are associated with poor response to CBT. Emerging evidence in animal and human studies suggests that the peroxisome proliferator-activated receptor-gamma (PPAR- γ) agonist, pioglitazone, improves white matter integrity that is essential for cognitive function. This project will determine whether adjunctive use of pioglitazone enhances the effect of CBT in preventing relapse during the early phase of recovery from cocaine use disorder. This paper describes the design of a mechanism-focused phase 2 randomized clinical trial that aims first to evaluate the effects of pioglitazone on targeted mechanisms related to white matter integrity, cognitive function, and cocaine craving; and second, to evaluate the extent to which improvements on target mechanisms predict CBT response. Positive results will support pioglitazone as a potential cognitive enhancing agent to advance to later stage medication development research. [ABSTRACT FROM AUTHOR]

Abstract: Background: The dopamine precursor levodopa has shown some, albeit relatively weak, promise in treating cocaine dependence. This study sought to identify the most appropriate behavioral therapy platform for levodopa pharmacotherapy by evaluating its effect when administered in combination with behavioral platforms of varying intensities. Method: A total of 161 treatment-seeking cocaine dependent subjects received sustained release levodopa/carbidopa (400/100mg bid, Sinemet) or placebo delivered in combination with Clinical Management (ClinMan); ClinMan+cognitive behavioral therapy (CBT); or ClinMan+CBT+voucher-based reinforcement therapy (VBRT) in a 12-week randomized, placebo-controlled, double-blind (for medication condition) trial. Medication compliance was monitored with riboflavin (100mg/capsule) and the Medication Event Monitoring System. Protocol compliance was addressed in weekly, 10-min nurse-delivered ClinMan sessions. Weekly, 1-h CBT sessions focused on coping skills training. VBRT (with escalating reinforcer value) provided cash-valued vouchers contingent on cocaine-negative urine toxicology results. Urine benzoylecgonine assays collected thrice-weekly were analyzed by intention-to-treat criteria using generalized linear mixed models. Results: Levodopa main effects were found on all outcome measures of cocaine use. Contrasts testing the levodopa-placebo difference within each behavioral platform found reliable effects, favoring levodopa, only in the VBRT platform. Levodopa treatment with vouchers produced higher proportions of cocaine-negative urines and longer periods of consecutive abstinence compared to other treatment combinations. Conclusion: This is the first study to find a significant treatment effect for levodopa and, in doing so, to demonstrate that the magnitude of this effect is dependent upon conditions of the behavioral therapy platform. The data support use of levodopa with abstinence-based reinforcement therapy as one efficacious combination in cocaine dependence disorder treatment. [Copyright &y& Elsevier]

Abstract: Rationale: The role of dopamine in cocaine abuse has been long recognized. Cocaine use can profoundly alter dopaminergic functioning through depletion of this monoamine and changes in receptor functioning. Based on these facts, levodopa (L-dopa) pharmacotherapy may be helpful in reducing or abolishing cocaine use. Objective: The current studies sought to evaluate the safety, tolerability and efficacy of L-dopa as a treatment for cocaine dependence. Methods: In Study 1, 67 cocaine-dependent subjects were randomized in a 5-week, double-blind, placebo-controlled safety trial. Subjects received either placebo, or 400mg L-dopa plus 100mg of the peripheral decarboxylase inhibitor, carbidopa, in a sustained-release preparation (Sinemet CR®). In Study 2, 122 cocaine-dependent subjects were enrolled in a 9-week, randomized, double-blind, placebo-controlled trial to compare placebo to 400/100mg and 800/200mg L-dopa/carbidopa treatments. Placebo or L-dopa were administered twice daily in both studies. Results: L-dopa was well tolerated with similar retention and medication adherence rates compared to placebo. Only two side effects occurred more often in L-dopa-treated patients: nausea and dizziness. L-dopa lowered diastolic blood pressure in a dose-dependent fashion. In these trials, L-dopa had no effect on cocaine use, cocaine craving, or mood. Conclusion: These two studies demonstrate the safety and tolerability of L-dopa pharmacotherapy in cocaine-dependent patients. No evidence for greater efficacy of L-dopa compared to placebo was observed. The possibility of enhancing treatment effects by combining L-dopa with other behavioral or pharmacological interventions is discussed. [Copyright &y& Elsevier]

The prevalence of smoking among alcohol abusers is high, yet little is known about this dual-dependency. This study examines mechanisms involved in changing both alcohol and tobacco use concurrently using the transtheoretical model (TTM) measures of change. Alcohol and tobacco dependent outpatients (N=115) entering a dual-substance dependence program were compared on baseline measures of motivation, self-initiated change activities, and self-efficacy associated with each substance use behavior. Differences on these measures were expected for drinking versus smoking. Motivation to change each behavior was also examined as a potential predictor of retention in treatment. Results indicated that patients reported higher self-efficacy to abstain and lower temptation to use alcohol relative to cigarettes. Change activities were also initiated at higher levels for drinking compared with smoking. An interaction between drinking and smoking motivation for change was found in the prediction of treatment retention; those with higher motivation for changing their alcohol use and lower motivation to quit smoking remained longer in treatment, while those who were higher in motivation for changing both behaviors dropped out the earliest. Overall, participants in this dual-dependence program were more confident and active in changing their alcohol use. Initiating cessation of both behaviors equally and simultaneously may prove difficult for this population. This study initiates an understanding of the mechanisms involved in changing alcohol–tobacco dependence and may provide guidance for developing dual cessation interventions. [Copyright &y& Elsevier]

Objective: To evaluate a hospital-initiated intervention to reduce tobacco smoke exposure in infants in the neonatal intensive care unit.Study Design: A randomized, controlled trial compared motivational interviewing plus financial incentives with conventional care on infant urine cotinine at 1 and 4 months' follow-up. Mothers of infants in the neonatal intensive care unit (N = 360) who reported a smoker living in the home were enrolled. Motivational interviewing sessions were delivered in both the hospital and the home. Financial incentives followed session attendance and negative infant cotinine tests postdischarge.Results: The intervention effect on infant cotinine was not significant, except among mothers who reported high baseline readiness/ability to protect their infant (P ≤ .01) and mothers who completed the study within 6 months postdischarge (per protocol; P ≤ .05). Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01). More mothers in the motivational interviewing plus financial incentives group reported a total home and car smoking ban at follow-up (P ≤ .05).Conclusions: Motivational interviewing combined with financial incentives reduced infant tobacco smoke exposure in a subset of women who were ready/able to protect their infant. The intervention also resulted in less maternal smoking postpartum. More robust interventions that include maternal and partner/household smoking cessation are likely needed to reduce the costly effects of tobacco smoke exposure on children and their families.Trial Registration: ClinicalTrials.gov: NCT01726062. [ABSTRACT FROM AUTHOR]

Behavioral therapies are considered best practices in the treatment of substance use disorders (SUD) and used as first-line approaches for SUDs without FDA-approved pharmacotherapies. Decades of research on the neuroscience of drug reward and addiction have informed the development of current leading behavioral therapies that, while differing in focus and technique, have in common the overarching goal of shifting reward responding away from drug and toward natural non-drug rewards. This review begins by describing key neurobiological processes of reward in addiction, followed by a description of how various behavioral therapies address specific reward processes. Based on this review, a conceptual 'map' is crafted to pinpoint gaps and areas of overlap, serving as a guide for selecting and integrating behavioral therapies. • Many theories posit addiction as a disorder of reward. • Correspondingly, behavior therapies for addiction operate on reward mechanisms. • The neurobiology of reward reveals there are several separable reward processes. • We examine which reward processes are addressed by behavior therapies for addiction. [ABSTRACT FROM AUTHOR]

Abstract: Background: Over one-third of all children live with at least one parent who smokes cigarettes, which is associated with compromised child health. The impact of secondhand smoke exposure (SHSe) in medically fragile infants born prematurely is likely to be much higher. The Baby's Breath II study tests whether a hospital-initiated, motivational-enhancement program will result in less SHSe relative to conventional care in high-risk, low birthweight (LBW) infants discharged from a neonatal intensive care unit (NICU). The design and protocol for the ongoing BBII trial is described. Methods/design: Eligible participants are: (1) primary caregivers (typically mothers) of NICU infants who were born at LBW (<2500g) or ventilated for more than 12h; and (2) who smoke or live with at least one smoker. This randomized controlled trial has two conditions: Motivational interviewing plus incentives (MI+) and conventional care (CC). MI+ participants receive two hospital-based and two home-based counseling sessions, as well as incentives (i.e., prize-based draws) for (a) intervention attendance and (b) biochemical validation (i.e., urine cotinine dipstick) indicative of low or no infant SHSe. Participants in the control group receive conventional education-based care. Assessments are completed at baseline, mid-point, and 1- and 4-months post-intervention. Discussion: This study is the first to determine the efficacy of a brief intervention for reducing SHSe among high-risk, LBW infants discharged from a NICU, with the potential for saving lives and healthcare costs. Strengths, limitations and challenges to the conduct of this trial are discussed. [Copyright &y& Elsevier]