Clinical and psychosocial outcomes by sex among individuals prescribed buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX) for opioid use disorder.

BACKGROUND AND OBJECTIVES: Limited research has explored sex differences in opioid use disorder medication (MOUD) treatment outcomes. The purpose of this study was to examine MOUD initiation onto buprenorphine-naloxone (BUP-NX) versus extended-release naltrexone (XR-NTX) by sex, and sex differences in clinical and psychosocial outcomes. METHODS: Using data from a 24-week open-label comparative effectiveness trial of BUP-NX or XR-NTX, this study examined MOUD initiation (i.e., receiving a minimum one XR-NTX injection or first BUP-NX dose) and 24-week self-report outcomes. We used regression models to estimate the probability of MOUD initiation failure among the intent-to-treat sample (N = 570), and the main and interaction effects of sex on outcomes of interest among the subsample of participants who successfully initiated MOUD (n = 474). RESULTS: In the intent-to-treat sample, the odds of treatment initiation failure were not significantly different by sex. In the subsample of successful MOUD initiates, the effect of treatment on employment at week 24 was significantly moderated by sex (p = .003); odds of employment were not significantly different among males by MOUD type; females randomized to XR-NTX versus BUP-NX had 4.63 times greater odds of employment (p < .001). Males had significantly lower odds of past 30-day exchanging sex for drugs versus females (adjusted odds ratios [aOR] = 0.10, p = .004), controlling for treatment and baseline outcomes. DISCUSSION AND CONCLUSIONS: Further research should explore how to integrate employment support into OUD treatment to improve patient outcomes, particularly among women. SCIENTIFIC SIGNIFICANCE: The current study addressed gaps in the literature by examining sex differences in MOUD initiation and diverse treatment outcomes in a large, national sample.

Addiction Psychiatry and Addiction Medicine: The Evolution of Addiction Physician Specialists.

Addiction Psychiatry and Addiction Medicine are two physician subspecialities recognized by the American Board of Medical Specialties (ABMS) that focus on providing care for patients with substance use disorders. Their shared and distinct historical roots are reviewed, and their respective ABMS board examination content areas and Accreditation Council on Graduate Medical Education (ACGME) fellowship training program requirements are compared. Addiction Psychiatry, a subspecialty under the American Board of Psychiatry and Neurology, began certifying diplomates in 1993, currently has 1202 active diplomates, and certifies around 150 diplomates every 2 years through 50 ACGME-accredited fellowships. Addiction Medicine, a subspecialty under the American Board of Preventive Medicine, began certifying diplomates in 2018, has 2604 diplomates with more expected before the practice pathway closes (anticipated in 2021), after which a fellowship training becomes required. Currently there are 78 accredited Addiction Medicine fellowships and more under development. The fields display substantial overlap between their respective examination content areas and fellowship training requirements, covering similar knowledge and skills for evaluation and treatment of substance use disorders and psychiatric and medical comorbidities across the full range of clinical settings, from general medical to addiction specialty settings. Key differences include that Addiction Psychiatry is open only to Board-certified psychiatrists and places extra emphasis on psychotherapeutic and psychopharmacological management strategies. Addiction Medicine is open to any ABMS primary specialty, including psychiatry. Opportunities for collaboration are discussed as both fields pursue the common goal of providing a well-trained workforce of physicians to meet the public health challenge presented by addiction. (Am J Addict 2020;00:00-00).

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse.

Background: Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder. Objective: To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone. Design: Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs. Data Sources: Study instruments. Target Population: Adults with opioid use disorder. Time Horizon: 24-week intervention with an additional 12 weeks of observation. Perspective: Health care sector and societal. Interventions: Buprenorphine-naloxone and extended-release naltrexone. Outcome Measures: Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids. Results of Base-Case Analysis: 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. Results of Sensitivity Analysis: The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation. Limitation: Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs. Conclusion: 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. Primary Funding Source: National Institute on Drug Abuse, National Institutes of Health.

Development of a Cascade of Care for responding to the opioid epidemic.

Amid worsening opioid overdose death rates, the nation continues to face a persistent addiction treatment gap limiting access to quality care for opioid use disorder (OUD). Three FDA-approved medications (methadone, buprenorphine, and extended-release naltrexone) have high quality evidence demonstrating reductions in drug use and overdose events, but most individuals with OUD do not receive them. The development of a unified public health framework, such as a Cascade of Care, could improve system level practice and treatment outcomes. In response to feedback from many stakeholders over the past year, we have expanded upon the OUD treatment cascade, first published in 2017, with additional attention to prevention stages and both individual-level and population-based services to better inform efforts at the state and federal level. The proposed cascade framework has attracted considerable interest from federal agencies including the Centers for Disease Control and Prevention (CDC) and National Institute on Drug Abuse (NIDA) along with policy-makers nationwide. We have reviewed recent literature and evidence-based interventions related to prevention, identification, and treatment of individuals with OUD and modeled updated figures from the 2016 National Survey on Drug Use and Health. Many currently employed interventions (prescriber guidelines, prescription monitoring programs, naloxone rescue) address prevention of OUD or downstream complications but not treatment of the underlying disorder itself. An OUD Cascade of Care framework could help structure local and national efforts to combat the opioid epidemic by identifying key targets, interventions, and quality indicators across populations and settings to achieve these ends. Improved data collection and reporting methodology will be imperative.

Cognitive functioning and treatment outcomes in a randomized controlled trial of internet-delivered drug and alcohol treatment.

BACKGROUND AND OBJECTIVES: Substance use disorders are associated with lower cognitive functioning, and this impairment is associated with poorer outcomes. The Therapeutic Education System (TES) is an internet-based psychosocial intervention for substance use disorders that may provide enhanced treatment for individuals with cognitive deficits. This secondary analysis investigates the association between cognitive functioning and treatment outcomes in a large (N = 507) randomized controlled effectiveness trial of TES compared to treatment-as-usual conducted within outpatient programs in the National Drug Abuse Treatment Clinical Trials Network. METHODS: All participants completed a computer-based cognitive assessment (Microcog™ short version) at baseline. Scores on subtests of attention, reasoning, and spatial perception were tested as moderators of the treatment effect on abstinence and retention at the end of the 12-week treatment phase using mixed effects logistic regression. RESULTS: Cognitive functioning was not found to be a moderator of treatment on abstinence or retention. Post-hoc analysis of the main effect of cognitive functioning on retention and abstinence found impaired reasoning and cognitive flexibility were associated with lower retention. There were no other main effects of cognitive functioning on retention or abstinence. CONCLUSIONS: The benefit of internet delivered treatment over standard care was unchanged across a range of cognitive functioning. Consistent with previous research, mild to moderate impairment in reasoning and cognitive flexibility were associated with lower retention across both treatment arms. SCIENTIFIC SIGNIFICANCE: An internet-delivered cognitive behavioral intervention for substance use disorders, TES, is equally effective across a spectrum of cognitive functioning among diverse patients. (Am J Addict 2018;27:509-515).

New Directions in Medication-Facilitated Behavioral Treatment for Substance Use Disorders.

A promising approach to addressing substance use disorders is to integrate pharmacotherapy with a behavioral treatment with which synergy is possible. In this review, we focus on recent research suggesting that this approach may be effective for cocaine and cannabis use disorders, both of which currently lack efficacious medications. We summarize potential targets of pharmacotherapy of particular relevance to combined medication-behavioral treatment and examine preliminary evidence of clinical efficacy. Common to these promising medications is a hypothesized mechanism of action predicated on reversing drug-related neural adaptations, such as high reactivity to stress or drug cues, that might undermine fruitful engagement with behavioral treatment. We also review emerging medications, such as certain glutamatergic and serotonergic agents, which may be feasibly integrated with existing treatments. We conclude with an outline of future directions for research.

Rapid Initiation of Injection Naltrexone for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Clinical Trial.

Importance: Injectable extended-release (XR)-naltrexone is an effective treatment option for opioid use disorder (OUD), but the need to withdraw patients from opioid treatment prior to initiation is a barrier to implementation. Objective: To compare the effectiveness of the standard procedure (SP) with the rapid procedure (RP) for XR-naltrexone initiation. Design, Setting, and Participants: The Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone study was an optimized stepped-wedge cluster randomized trial conducted at 6 community-based inpatient addiction treatment units. Units using the SP were randomly assigned at 14-week intervals to implement the RP. Participants admitted with OUD received the procedure the unit was delivering at the time of their admission. Participant recruitment took place between March 16, 2021, and July 18, 2022. The last visit was September 21, 2022. Interventions: Standard procedure, based on the XR-naltrexone package insert (approximately 5-day buprenorphine taper followed by a 7- to 10-day opioid-free period and RP, defined as 1 day of buprenorphine at minimum necessary dose, 1 opioid-free day, and ascending low doses of oral naltrexone and adjunctive medications (eg, clonidine, clonazepam, antiemetics) for opioid withdrawal. Main Outcomes and Measures: Receipt of XR-naltrexone injection prior to inpatient discharge (primary outcome). Secondary outcomes included opioid withdrawal scores and targeted safety events and serious adverse events. All analyses were intention-to-treat. Results: A total of 415 participants with OUD were enrolled (mean [SD] age, 33.6 [8.48] years; 205 [49.4%] identified sex as male); 54 [13.0%] individuals identified as Black, 91 [21.9%] as Hispanic, 290 [69.9%] as White, and 22 [5.3%] as multiracial. Rates of successful initiation of XR-naltrexone among the RP group (141 of 225 [62.7%]) were noninferior to those of the SP group (68 of 190 [35.8%]) (odds ratio [OR], 3.60; 95% CI, 2.12-6.10). Withdrawal did not differ significantly between conditions (proportion of days with a moderate or greater maximum Clinical Opiate Withdrawal Scale score (>12) for RP vs SP: OR, 1.25; 95% CI, 0.62-2.50). Targeted safety events (RP: 12 [5.3%]; SP: 4 [2.1%]) and serious adverse events (RP: 15 [6.7%]; SP: 3 [1.6%]) were infrequent but occurred more often with RP than SP. Conclusions and Relevance: In this trial, the RP of XR-naltrexone initiation was noninferior to the standard approach and saved time, although it required more intensive medical management and safety monitoring. The results of this trial suggest that rapid initiation could make XR-naltrexone a more viable treatment for patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT04762537.

Exploring the performance of during-treatment substance use outcome measures in predicting longer-term psychosocial functioning and post-treatment abstinence.

BACKGROUND: The selection of appropriate efficacy endpoints in clinical trials has been a long-standing challenge for the substance use disorder field. Using data from a large, multi-site National Drug Abuse Treatment Clinical Trials Network trial (CTN-0044; n=474), this secondary data analysis aimed to explore whether specific proximal (during-treatment) substance use outcome measures predict longer-term improvements in psychosocial functioning and post-treatment abstinence, and whether predictions vary depending on the specific substance (cannabis, cocaine/stimulants, opioids, and alcohol). METHODS: Generalized linear mixed models examined associations between six during-treatment substance use outcome measures and social functioning impairment (Social Adjustment Scale Self-Report) and severity of psychiatric symptoms (Brief Symptom Inventory-18) at end-of-treatment, and 3- and 6-months after treatment as well as post-treatment abstinence. RESULTS: Maximum days of consecutive abstinence, proportion of days abstinent, ≥3 weeks of continuous abstinence, and the proportion of urine specimens negative for the primary substance were associated with post-treatment psychiatric and social functioning improvement and abstinence. However, only the effects of abstinence during the last 4 weeks of the treatment period on all three post-treatment outcomes was stable over time and did not differ between primary substance groups. In contrast, complete abstinence during the 12-week treatment period was not consistently associated with functioning improvements. CONCLUSIONS: Substance use outcome measures capturing the duration of primary substance abstinence during treatment are suitable predictors of post-treatment abstinence and longer-term psychosocial functioning improvement. Binary outcomes, such as end-of-treatment abstinence, may be particularly stable predictors and attractive given their ease of computation and straightforward clinical interpretability.

Homelessness and Treatment Outcomes Among Black Adults With Opioid Use Disorder: A Secondary Analysis of X:BOT.

OBJECTIVE: We sought to identify the sociodemographic and clinical characteristics associated with homelessnesss, and explore the relationship between homelessnesss and treatment outcomes among Black individuals. METHODS: This is a secondary analysis of the subgroup of Black participants (n = 73) enrolled in "X:BOT," a 24-week multisite randomized clinical trial comparing the effectiveness of extended-release naltrexone versus sublingual buprenorphine-naloxone (n = 570). Outcomes included medication initiation, return to extramedical use of opioids assessed by both self-report and urine toxicology, and engagement in medications for opioid use disorder (MOUD) treatment at 28 weeks postrandomization. Descriptive statistics were performed. RESULTS: Black participants were mostly unmarried and male, and about a third were aged 21-30 years. Among people experiencing homelessnesss, more were uninsured (45.5% [10/22] vs 19.6% [10/51]), unemployed (77.3% [17/22] vs 64.7% [33/51]), and reported alcohol (40.9% [9/22] vs 23.5% [12/51]) and sedative use (54.5% [12/22] vs 17.6% [9/51]) within the previous 30 days. Compared with housed Black individuals, a slightly higher proportion of Black individuals experiencing homelessnesss successfully initiated study medication (81.1% [18/22] vs 72.6% [37/51]); similar proportions returned to opioid use during the trial (68.2% [15/22] vs 68.6% [35/51]) and were engaged in MOUD at 28 weeks after trial entry (72.2% [13/18] vs 69.7% [23/33]) among participants located for follow-up. CONCLUSIONS: These descriptive results among Black patients participating in a trial of MOUD suggest that efficacious MOUD is possible despite homelessnesss with additional clinical supports such as those provided by a clinical trial.

Community selected strategies to reduce opioid-related overdose deaths in the HEALing (Helping to End Addiction Long-term SM) communities study.

The Helping End Addictions Long Term (HEALing) Communities Study (HCS) seeks to significantly reduce overdose deaths in 67 highly impacted communities in Kentucky (KY), Massachusetts (MA), New York (NY), and Ohio (OH) by implementing evidence-based practices (EBPs) to reduce overdose deaths. The Opioid-overdose Reduction Continuum of Care Approach (ORCCA) organizes EBP strategies under three menus: Overdose Education and Naloxone Distribution (OEND), Medication Treatment for Opioid Use Disorder (MOUD), and Safer Prescribing and Dispensing Practices (SPDP). The ORCCA sets requirements for strategy selection but allows flexibility to address community needs. This paper describes and compiles strategy selection and examines two hypotheses: 1) OEND selections will differ significantly between communities with higher versus lower opioid-involved overdose deaths; 2) MOUD selections will differ significantly between urban versus rural settings. METHODS: Wave 1 communities (n = 33) provided data on EBP strategy selections. Selections were recorded as a combination of EBP menu, sector (behavioral health, criminal justice, and healthcare), and venue (e.g., jail, drug court, etc.); target medication(s) were recorded for MOUD strategies. Strategy counts and proportions were calculated overall and by site (KY, MA, NY, OH), setting (rural/urban), and opioid-involved overdose deaths (high/low). RESULTS: Strategy selection exceeded ORCCA requirements across all 33 communities, with OEND strategies accounting for more (40.8%) than MOUD (35.1%), or SPDP (24.1%) strategies. Site-adjusted differences were not significant for either hypothesis related to OEND or MOUD strategy selection. CONCLUSIONS: HCS communities selected strategies from the ORCCA menu well beyond minimum requirements using a flexible approach to address unique needs.

Opioid detoxification and naltrexone induction strategies: recommendations for clinical practice.

BACKGROUND: Opioid dependence is a significant public health problem associated with high risk for relapse if treatment is not ongoing. While maintenance on opioid agonists (i.e., methadone, buprenorphine) often produces favorable outcomes, detoxification followed by treatment with the µ-opioid receptor antagonist naltrexone may offer a potentially useful alternative to agonist maintenance for some patients. METHOD: Treatment approaches for making this transition are described here based on a literature review and solicitation of opinions from several expert clinicians and scientists regarding patient selection, level of care, and detoxification strategies. CONCLUSION: Among the current detoxification regimens, the available clinical and scientific data suggest that the best approach may be using an initial 2-4 mg dose of buprenorphine combined with clonidine, other ancillary medications, and progressively increasing doses of oral naltrexone over 3-5 days up to the target dose of naltrexone. However, more research is needed to empirically validate the best approach for making this transition.

Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes.

INTRODUCTION: Patient engagement may play a key role in the success or failure of treatments for substance use disorder (SUD). This exploratory analysis of data from a large, multisite effectiveness trial (NCT01104805) sought to determine how patient engagement with a digital therapeutic for SUD delivered at clinics was associated with abstinence outcomes. METHODS: The study evaluated engagement for 206 participants enrolled in a treatment program for SUDs related to cocaine, alcohol, cannabis, or other stimulants who were randomized to receive treatment as usual (TAU) or reduced TAU plus the digital Therapeutic Education System (TES) for 12 weeks. Participants were eligible for contingency management incentives for module completion (modules cover Community Reinforcement Approach topic areas) and negative urine drug screens. Analyses examined the association of module completion with end-of-treatment abstinence. RESULTS: Participants completed a mean of 38.8 (range 0-72) TES modules over 12 weeks of treatment. Study completers (n = 157) completed a mean of 45.5 (range 9-72) TES modules, whereas study noncompleters (n = 49) completed a mean of 17.4 (range 0-45) TES modules. The study observed a strong positive correlation between TES engagement (i.e., total number of modules completed) and the probability of abstinence during weeks 9-12 of treatment among 157 study completers (OR = 1.11; 95% CI 1.08-1.14). Each module completed increased the odds of abstinence during weeks 9-12 by approximately 11% for study completers and 9% for the full sample. The study observed a similar, but weaker, association between engagement and abstinence among 49 patients who did not complete the study (OR = 1.02; 95% CI 0.98-1.07). CONCLUSIONS: Greater engagement with a digital therapeutic for patients with SUD (i.e., number of modules completed over time) was strongly associated with the probability of abstinence in the last four weeks of treatment among those who completed the recommended 12-week treatment. TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT01104805.

Support for COVID-19-Related Substance Use Services Policy Changes: a New York State-Wide Survey.

This study aims to describe which substance use service (SUS) organizations and who within these organizations support the maintenance of policies targeted at improving substance use treatment services. An online survey assessing respondent, organizational and program demographics, and knowledge and support regarding policy changes was distributed to all certified SUS and harm reduction programs in NYS. Bivariate and latent class analyses were used to identify patterns and associations to policy choices. Across the 227 respondents, there was a support for maintaining expansion of insurance coverage, virtual behavioral health/counseling and medication initiation/maintenance visits, reductions in prior authorizations, and access to prevention/harm reduction services. Three classes of support for policies were derived: (1) high-supporters (n = 49; 21%), (2) low-supporters (n = 66; 29%), and (3) selective-supporters. Having knowledge of policy changes was associated with membership in the high-supporters class. Implications regarding the role of knowledge in behavioral health policies dissemination structures, decision-making, and long-term expansion of SUS are discussed.

Medication treatment for opioid use disorder in the age of COVID-19: Can new regulations modify the opioid cascade?

The temporary loosening of regulations governing methadone and buprenorphine treatment for opioid use disorder (OUD) in the U.S., instituted to prevent the spread of COVID-19, has created an opportunity to explore the effectiveness of new models of care for people with OUD. The opioid cascade describes the current status of the treatment system, where only a fraction of people with OUD initiate effective medication treatment for OUD (MOUD), and of those only a fraction is retained in treatment. Regulatory changes-such as availability of larger take-home supplies of methadone and buprenorphine initiated via telemedicine (e.g., no initial in person visit; telemedicine buprenorphine permitted across state lines)-could modify the cascade, by reducing the burden and increasing the attractiveness, availability, and feasibility of MOUD both for people with OUD and for providers. We review examples of more liberal MOUD regimens, including the implementation of buprenorphine in France in the 1990s, primary care-based methadone in Canada, and low-threshold buprenorphine models. Research is needed to document whether new models implemented in the U.S. in the wake of COVID-19 are successful, and whether safety concerns, such as diversion and misuse, emerge. We discuss barriers to implementation, including racial and ethnic health disparities, and lack of knowledge and reluctance among potential providers of MOUD. We suggest that the urgency and public spiritedness of the response to COVID-19 be harnessed to make gains on the opioid cascade, inspiring prescribers, health systems, and communities to embrace the delivery of MOUD to meet the needs of an increasingly vulnerable population.

Sublingual Buprenorphine-Naloxone Compared With Injection Naltrexone for Opioid Use Disorder: Potential Utility of Patient Characteristics in Guiding Choice of Treatment.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study.

Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA's Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women's health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk.

The relationship between depression and smoking cessation outcomes in treatment-seeking substance abusers.

The National Drug Abuse Treatment Clinical Trials Network (CTN) recently completed a randomized, open label trial comparing treatment as usual (TAU) combined with nicotine patches plus cognitive behavioral group counseling for smoking cessation (n = 153) to TAU alone (n = 72) for patients enrolled in treatment programs for drug or alcohol dependence, who were interested in quitting smoking. This report is a secondary analysis evaluating the effect of depressive symptomatology (n = 70) or history of depression (n = 110) on smoking cessation outcomes. A significant association was seen between measures of depression and difficulty quitting cigarettes. Specifically, there was a greater probability for smoking abstinence for those with lower baseline Beck Depression Inventory II (BDI-II) scores. These data suggest that evaluation and treatment of depressive symptoms may play an important role in improving smoking cessation outcomes. (Am J Addict 2010;00:1-8).

Buprenorphine Treatment for Opioid Use Disorder: An Overview.

Opioid use disorder affects over 26 million individuals worldwide. There are currently three World Health Organization-recommended and US Food and Drug Administration-approved medication treatments for opioid use disorder: the full opioid agonist methadone, the opioid partial agonist buprenorphine, and the opioid receptor antagonist naltrexone. We provide a review of the use of buprenorphine for the treatment of opioid use disorder and discuss the barriers, challenges, risks, and efficacy of buprenorphine treatment vs. other treatments. Although evidence from numerous studies has shown buprenorphine to be effective for the treatment of opioid use disorder, a majority of patients with opioid use disorder do not receive buprenorphine, or any other medical treatment. We review the different formulations of buprenorphine, including newer long-acting injectable formulations that may decrease the risk of diversion and improve adherence.

Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.

OBJECTIVES: To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory. METHODS: Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254). RESULTS: Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes. CONCLUSIONS: Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.

A Randomized Trial Comparing Extended-Release Injectable Suspension and Oral Naltrexone, Both Combined With Behavioral Therapy, for the Treatment of Opioid Use Disorder.

OBJECTIVE: The oral formulation of the opioid antagonist naltrexone has shown limited effectiveness for treatment of opioid use disorder due to poor adherence. Long-acting injection naltrexone (XR-naltrexone), administered monthly, circumvents the need for daily pill taking, potentially improving adherence, and has been shown to be superior to placebo in reducing opioid use over 6 months of treatment. This open-label trial compared the outcomes of patients with opioid use disorder treated with XR-naltrexone or oral naltrexone in combination with behavioral therapy. METHOD: Sixty opioid-dependent adults completed inpatient opioid withdrawal and were transitioned to oral naltrexone. They were stratified by severity of opioid use (six or fewer bags versus more than six bags of heroin per day) and randomly assigned (1:1) to continue treatment with oral naltrexone (N=32) or XR-naltrexone (N=28) for 24 weeks. The first dose of XR-naltrexone (380 mg) was administered prior to discharge, with monthly doses thereafter, and oral naltrexone was given in a 50-mg daily dose. All participants received weekly behavioral therapy to support treatment and adherence to naltrexone. RESULTS: A Cox proportional hazards model adjusting for race, gender, route of use, and baseline opioid use severity indicated that significantly more patients were retained in treatment for 6 months in the XR-naltrexone group (16 of 28 patients, 57.1%) than in the oral naltrexone group (nine of 32 patients, 28.1%) (hazard ratio=2.18, 95% CI=1.07, 4.43). CONCLUSIONS: Patients receiving XR-naltrexone had twice the rate of treatment retention at 6 months compared with those taking oral naltrexone. These results support the use of XR-naltrexone combined with behavioral therapy as an effective treatment for patients seeking opioid withdrawal and nonagonist treatment for preventing relapse to opioid use disorder.