Examining Overdose and Homelessness as Predictors of Willingness to Use Supervised Injection Facilities by Services Provided Among Persons Who Inject Drugs.

BACKGROUND AND OBJECTIVES: Internationally, supervised injection facilities (SIFs) have demonstrated efficacy in reducing rates of overdose and promoting entry into treatment among persons who inject drugs (PWID); however, they remain unavailable in the United States. Early findings examining American PWID illustrate high overall willingness to use SIFs. The current study expands upon this research by examining PWID's likelihood to use SIFs based on services offered (eg, provides clean needles, linkage to treatment programs) and whether known risk factors (prior overdose, homelessness) influence PWID's willingness to use a SIF. METHODS: Participants (n = 184) were patients entering short-term inpatient opioid withdrawal management in Massachusetts between May 2018 and February 2019 who reported injection drug use in the prior 30 days. We examined PWID's likelihood to use a SIF if eight unique services were available, and compared if this differed by overdose history and homelessness status using ordered logistic regression and Pearson's χ2 -tests of independence. RESULTS: Participants (34.2 [±8.3 SD] years of age, 68.5% male, 85.9% white, 8.2% Hispanic) reported being most likely to use SIFs that provided safety from police intervention (86.7%), entry into withdrawal management (85.9%), or clean needles (83.2%). Drug works disposal and safety from police were particularly important for PWID with a history of overdose. CONCLUSION AND SCIENTIFIC SIGNIFICANCE: Overall, treatment-seeking PWIDs reported greater willingness to utilize SIFs if particular services were provided. These findings point to features of SIFs that may enhance treatment-seeking PWID's amenability to utilizing these services if such sites open in the United States. (Am J Addict 2021;30:21-25).

Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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; p<0·0001). 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 (p<0·0001) and opioid-abstinent days (p<0·0001) 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). INTERPRETATION: 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. FUNDING: NIDA Clinical Trials Network.

Expectations about alcohol, cocaine, and benzodiazepine abstinence following inpatient heroin withdrawal management.

BACKGROUND AND OBJECTIVES: Polysubstance use is associated with relapse and poor treatment outcomes among people dependent on heroin. Despite the high prevalence of polysubstance use among patients detoxifying from heroin, little is known about patients' expectations to abstain or use non-opiate substances. The current study examined factors associated with expectations about abstaining from alcohol, cocaine, and benzodiazepines (BZDs) following heroin withdrawal management. METHODS: Between May and December of 2015, we surveyed 417 patients (71.9% male, 31.7 [±8.39] mean years old) initiating short-term inpatient heroin withdrawal management who reported alcohol, cocaine, or BZD use in the past 30 days. We used logistic regression to evaluate the adjusted associations of background characteristics with expectations about using each substance following discharge. RESULTS: Approximately half of respondents reported past month alcohol (52%), cocaine (47.0%), or BZD (47.0%) use, and 25.9% reported using all three substances. Approximately half of those reporting drinking, 6.6% reporting cocaine use, and 27% of reporting BZD use expected to abstain from using that substance following heroin withdrawal. Prior opioid withdrawal was associated with a lower likelihood of expecting to stop using alcohol and BZDs, and more days of BZD use was associated with a greater likelihood of expecting to abstain from BZDs following discharge. CONCLUSION: Persons with opioid use disorder often do not expect to stop using other substances following withdrawal management, with very few planning cocaine cessation. SCIENTIFIC SIGNIFICANCE: Inpatient heroin withdrawal programs need to address and educate patients about how polysubstance use complicates recovery from heroin use. (Am J Addict 2019;28:36-42).

Worries About Discontinuing Buprenorphine Treatment: Scale Development and Clinical Correlates.

BACKGROUND AND OBJECTIVES: Despite the benefits of maintenance buprenorphine treatment for opioid use disorder (OUD), many individuals report an interest in discontinuing the medication, while also expressing worries about tapering. The purpose of this study was to develop a measure of worries about buprenorphine discontinuation ("Off Bupe") and determine the demographic and clinical characteristics associated with these worries. METHODS: Between May 2017 and May 2018, we surveyed adults in an outpatient primary care buprenorphine program (n = 138). Reliability and validity of the Off Bupe measure were examined. RESULTS: Participants averaged 39 years of age, 54% were male, average duration of buprenorphine was 189 weeks and 85.5% reported eventually wanting to discontinue buprenorphine, although fewer than 10% were actively tapering. We derived two scales, withdrawal symptom worry (10 items, ɑ = 0.94) and relapse worry (7 items, ɑ = 0.88). Worry about symptoms was positively associated with current buprenorphine dose (P = 0.016), physical discomfort avoidance (P < 0.001), and inversely associated with self-efficacy to quit buprenorphine (P < 0.001) and distress tolerance (P < 0.001). Worry about opioid relapse was associated positively with age (P = 0.019), current buprenorphine dose (P = 0.004), physical discomfort avoidance (P < 0.001), and impulsivity (P = 0.002), and inversely associated with self-efficacy to quit buprenorphine (P < 0.001). DISCUSSION AND CONCLUSIONS: Psychometric evaluation of the "Off Bupe" scale demonstrated its content and construct validity and internal reliability. SCIENTIFIC SIGNIFICANCE: The scale might help individuals with OUD and their providers identify concerns about discontinuing buprenorphine. (Am J Addict 2019;28:270-276).

Perceived need for depression treatment among persons entering inpatient opioid detoxification.

BACKGROUND AND OBJECTIVES: Depression is common among persons with opioid use disorder. We examined the perceived need for depression treatment (PNDT) among opioid-dependent patients and the relationship of PNDT to depression screening result. METHODS: Between May and December 2015, we surveyed consecutive persons (n = 440) seeking inpatient opioid detoxification. We used the Patient Health Questionnaire-2 (PHQ-2) to screen for depression. To assess perceived need for depression services, participants were asked, "Do you believe you should be treated for depression?" Response options were recorded into four categories: "Not Depressed (ND)," "Perceive Need for Depression Treatment (PNDT)," "Depressed/Don't Want Treatment," and "Currently Treated." RESULTS: Participants' mean age was 32.3 (±8.7) years; 70.7% were male. Nearly two out of three persons screened positive for depression yet only 8.2% were being treated for depression prior to admission. Screening positive for depression was associated with a 2.95 (95%CI 1.82-4.81, p < .005) fold increase in the expected odds of PNDT. But nearly half of those depressed (48%) did not perceive the need for treatment. Approximately 40% of the participants (n = 177) perceived that they were not depressed; of these persons, 52% screened positive for depression. DISCUSSION AND CONCLUSIONS: Detoxification program staff should screen patients for depression, and if a clinical diagnosis is confirmed, discuss treatment options, exploring the level of interest in mental health treatment for depression. SCIENTIFIC SIGNIFICANCE: Screening for and addressing depression, including patients' interest in treatment, should be central to post-detoxification aftercare planning. (Am J Addict 2017;26:395-399).

Knowledge, past use, and willingness to start medication-assisted treatment among persons undergoing alcohol detoxification.

BACKGROUND/OBJECTIVES: The current study examined knowledge of previous use, and willingness to take alcohol-related medication among individuals in medically supervised detoxification. METHODS: Participants (n = 302) provided health and demographic information, substance use and detoxification history, PCP visits, and AA attendance. RESULTS: Most patients had knowledge of alcohol medications, one-third had past prescription, and over 80% reported willingness to take medication. Previous detoxification predicted medication knowledge, while previous treatment predicted past prescription. DISCUSSION/CONCLUSIONS: More patients are willing to take medication than are prescribed medication. SCIENTIFIC SIGNIFICANCE: Findings suggest the opportunity to increase medication use following detoxification which could reduce subsequent relapse. (Am J Addict 2017;26:118-121).

Overdose history is associated with postdetoxification treatment preference for persons with opioid use disorder.

BACKGROUND: Without aftercare treatment, persons discharged from short-term inpatient detoxification for opioid use disorder are at high risk of relapse. In previous work, those who were recently homeless or had pending legal problems were more likely to prefer residential treatment for aftercare. Here, based on clinical experience, the authors hypothesize that a particular clinical factor, surviving an opioid overdose, will be associated with aftercare preference. METHODS: Between May and December 2015, the authors surveyed consecutive persons seeking inpatient opioid detoxification. To assess aftercare treatment preference, participants were asked, "If you had unlimited treatment options and all were free, which one would work best for you when you leave here?" To assess overdose history, participants were asked about overdose "since your first drug use," and "in the last year." RESULTS: Participants' (N = 440) mean age was 32.3 (± 8.7) years; 70.7% were male. More than half (51.1%) of participants expressed an aftercare preference for medication-assisted treatment (MAT), 12.7% for outpatient counseling only, 10.7% for residential treatment,18.6% for no formal treatment (Narcotics Anonymous/Alcoholics Anonymous only or a halfway house), and 6.8% did not want any postdetoxification treatment. About 40% reported a history of overdose, and 24.8% reported past year overdose. In the multivariate model, treatment preference was associated with sex (P < .001), homelessness (P = .01), and history of drug overdose (P = .02). CONCLUSIONS: Although MAT was preferred by the majority of participants, the experience of a nonfatal overdose was associated with the choice of residential treatment as postdetoxification treatment.

The overlap of sleep disturbance and depression in primary care patients treated with buprenorphine.

BACKGROUND: Sleep disturbance is common among patients receiving long-term opioid therapies, such as methadone maintenance. However, little is known about sleep disturbances in patients receiving medication treatment with buprenorphine. We sought to determine the frequency of subjective sleep disturbance in a sample of patients receiving medication treatment and to examine clinical factors related to sleep disturbance. METHODS: Participants were 328 persons receiving buprenorphine at 3 primary care sites. Sleep difficulty was assessed 2 questions adapted from the Patient Health Questionnaire-9 (PHQ-9) item assessing sleep. Depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (CESD)-10 and PHQ-2. In addition, information was gathered on participant demographics and treatment characteristics. Demographics, buprenorphine treatment history, and depressive symptoms were compared for those with and without self-reported sleep difficulty. Logistic regression was used to estimate the adjusted association of sleep disturbance with these correlates. RESULTS: Seventy-one percent of persons receiving medication treatment with buprenorphine in the present study reported sleep difficulty. Persons reporting sleep disturbance reported shorter time in buprenorphine treatment and more depressed mood compared with those without sleep difficulty (p < .01). Men were significantly less likely to report disturbed sleep than women (odds ratio [OR] = 0.57, 95% confidence interval [CI]: 0.33, 0.98). Sleep disturbance was not associated significantly with age, ethnicity, educational attainment, or buprenorphine dose. CONCLUSIONS: Sleep disturbance is common in patients receiving medication treatment with buprenorphine and is associated with more depressive symptoms as well as a shorter duration of medication treatment. Future research, using subjective and objective sleep measures, is warranted to understand whether sleep disturbance is mitigated by longer buprenorphine treatment and whether difficulty sleeping predicts buprenorphine discontinuation among patients seeking treatment for opioid dependence.

Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS.

In this pilot study, we assessed feasibility and acceptability of a behavior therapy intervention for pain and depressive symptoms in persons living with HIV/AIDS (PLWH). We randomly assigned 23 participants to HIV-PASS (HIV-Pain and Sadness Study) or a health education control arm for 3 months. On average, participants attended more than 5 sessions (of 7 possible) in both arms. Qualitative data suggest HIV-PASS participants understood key messages and made concrete behavioral changes. HIV-PASS was associated with effects in the expected direction for three of four outcomes, including the primary outcome (pain-related interference with functioning). Findings suggest that HIV-PASS is promising.

An Open Trial of Electronic Cigarettes for Smoking Cessation Among Methadone-Maintained Smokers.

INTRODUCTION: Smoking cessation pharmacotherapies tested in persons with opioid use disorder have produced low quit rates. Electronic cigarettes (e-cigarettes) have been used by many methadone-maintained (MMT) smokers, but controlled trials evaluating cessation and reduction outcomes have not been performed in this population with deleterious tobacco-related health consequences. METHODS: In this open trial of NJOY e-cigarettes, MMT smokers received 6 weeks of treatment and were instructed to use only e-cigarettes. Outcomes included carbon monoxide confirmed 7-day point smoking cessation prevalence at week 7 (end of treatment) and self-reported change in mean cigarettes per day (CPD) at each 2-week assessment. The final assessment was 2 weeks after treatment ended (week 9). RESULTS: The 12 participants averaged 46 years old and 50% were male. On average, participants reported smoking 17.8 (±5.3) CPD. One person had a biochemically confirmed quit at week 7. Participants tended to report marked reductions in mean CPD between quit day (week 1) and the week 3 assessment. Relative to baseline, statistically significant reductions in mean CPD were observed at all follow-up assessments. Mean reductions in CPD were -12.4 (95% confidence interval [CI]: -15.0, -9.9; P < .001), -14.8 (95% CI: -17.4, -12.2; P < .001), -13.9 (95% CI: -16.6, -11.2), and -10.8 (95% CI: -13.4, -8.2; P < .01) at the 3-, 5-, 7-, and 9-week assessments, respectively. Adherence to e-cigarettes was 89.1% during the 6 treatment weeks. CONCLUSIONS: E-cigarettes were associated with reductions in cigarette use. Smoking cessation rates in MMT smokers are low and whether long-term smoking reductions can persist and produce health benefits should be studied. IMPLICATIONS: E-cigarettes were associated with reduced tobacco use in MMT smokers. Adherence to e-cigarettes is high among methadone smokers. Week-7 smoking quit rates are similar to pharmacotherapies tested in this population.

Chronic pain and depression among primary care patients treated with buprenorphine.

BACKGROUND: Pain and depression are each prevalent among opioid dependent patients receiving maintenance buprenorphine, but their interaction has not been studied in primary care patients. OBJECTIVE: We set out to examine the relationship between chronic pain, depression, and ongoing substance use, among persons maintained on buprenorphine in primary care settings. DESIGN: Between September 2012 and December 2013, we interviewed buprenorphine patients at three practice sites. PARTICIPANTS: Opioid dependent persons at two private internal medicine offices and a federally qualified health center participated in the study. MAIN MEASURES: Pain was measured in terms of chronicity, with chronic pain being defined as pain lasting at least 6 months; and in terms of severity, as measured by self-reported pain in the past week, measured on a 0-100 scale. We defined mild chronic pain as pain severity between 0 and 39 and lasting at least 6 months, and moderate/severe chronic pain as severity ≥ 40 and lasting at least 6 months. To assess depression, we used the Center for Epidemiologic Studies Depression (CESD) ten-item symptom scale and the two-item Patient Health Questionnaire (PHQ-2). KEY RESULTS: Among 328 participants, 169 reported no chronic pain, 56 reported mild chronic pain, and 103 reported moderate/severe chronic pain. Participants with moderate/severe chronic pain commonly used non-opioid pain medications (56.3%) and antidepressants (44.7%), yet also used marijuana, alcohol, or cocaine (40.8%) to help relieve pain. Mean CESD scores were 7.1 (±6.8), 8.3 (±6.0), and 13.6 (±7.6) in the no chronic, mild, and moderate/severe pain groups, respectively. Controlling for covariates, higher CESD scores were associated with a higher likelihood of moderate/severe chronic pain relative to both no chronic pain (OR = 1.09, p < 0.001) and mild chronic pain (OR = 1.06, p = 0.04). CONCLUSION: Many buprenorphine patients are receiving over-the-counter or prescribed pain medications, as well as antidepressants, and yet continue to have significant and disabling pain and depressive symptoms. There is a clear need to address the pain-depression nexus in novel ways.

Chronic Pain in HIV-Infected Patients: Relationship to Depression, Substance Use, and Mental Health and Pain Treatment.

OBJECTIVE: As the advent of highly active antiretroviral therapy, HIV has become a chronic disease for most individuals in developed countries. Chronic pain is a common occurrence for HIV-infected patients and has an impact on quality of life and antiretroviral adherence. The objective of this study was to examine relationships between chronic pain and depression, substance use, mental health treatment, and pain treatment in HIV-infected patients. DESIGN: Cross-sectional study. SETTING: Three primary care sites where HIV+ patients receive treatment. SUBJECTS: Two hundred and thirty eight HIV-infected primary care patients. METHODS: We collected self-report and chart-review information on demographics, HIV clinical status, chronic pain, depression, substance use, mental health treatment, and pain treatment. We collected data between October 2012 and November 2013. RESULTS: Of the patients enrolled in this study, 107 reported no chronic pain, 24 reported mild chronic pain, and 107 reported moderate-severe chronic pain. Participants in the moderate-severe pain group were more likely to have high levels of depressive symptoms than those in the no chronic pain group. Similarly, there was a significant relationship between chronic pain status and interference with life activities due to pain. Participants with moderate-severe chronic pain were more likely to be taking an antidepressant medication than those with mild chronic pain, and more likely to be taking a prescription opioid than the other two groups. We did not find a significant relationship between problematic substance use and chronic pain status. CONCLUSIONS: Despite pharmacologic treatment, moderate-severe chronic pain and elevated depression symptoms are common among HIV-infected patients and frequently co-occur.

The Use of Technology in Participant Tracking and Study Retention: Lessons Learned From a Clinical Trials Network Study.

BACKGROUND: The growing use of newer communication and Internet technologies, even among low-income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the Internet to track participants in a multisite randomized trial of substance use disorder treatment. METHODS: Preinterview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 participating US sites. Data were then used to construct a semistructured interview guide that, in turn, was used to interview 12 of the same staff members. The questionnaires and interview data were entered in Atlas.ti and analyzed for emergent themes related to the use of technology for participant-tracking purposes. RESULTS: Study staff reported that most participants had cell phones, despite having unstable physical addresses and landlines. The incoming call feature of most cell phones was useful for participants and research staff alike, and texting proved to have additional benefits. However, reliance on participants' cell phones also proved problematic. Even homeless participants were found to have access to the Internet through public libraries and could respond to study staff e-mails. Some study sites opened generic social media accounts, through which study staff sent private messages to participants. However, the institutional review board (IRB) approval process for tracking participants using social media at some sites was prohibitively lengthy. Internet searches through Google, national paid databases, obituaries, and judiciary Web sites were also helpful tools. CONCLUSIONS: Research staff perceive that cell phones, Internet searches, and social networking sites were effective tools to achieve high follow-up rates in drug abuse research. Studies should incorporate cell phone, texting, and social network Web site information on locator forms; obtain IRB approval for contacting participants using social networking Web sites; and include Web searches, texting, and the use of social media in staff training as standard operating procedures.

Implementing substance abuse group therapy clinical trials in real-world settings: challenges and strategies for participant recruitment and therapist training in the Women's Recovery Group Study.

BACKGROUND AND OBJECTIVES: Open-enrollment group therapy research is challenged by the participant recruitment necessary to ensure continuous group enrollment. We present successful strategies to overcome the following barriers during the Women's Recovery Group (WRG) two-site clinical trial (N = 158): maintenance of sample size and balanced gender randomization during continuous enrollment, maintenance of group attendance, and training and retention of therapists over the 24-month continuous group enrollment. METHODS: To increase recruitment, we targeted referral sources yielding the highest enrollment conversion at each site. Group sessions were consistently held regardless of group size. Therapists were trained in two teams allowing for coverage and uninterrupted treatment over 24 months. RESULTS: At both sites recruitment and enrollment increased with each successive quarter. Sample size and end date targets were met without disruptions in treatment. Group therapists reported high satisfaction with their training and treatment experiences. DISCUSSION AND CONCLUSIONS: These strategies supported targeted enrollment and study duration, stability of open-enrollment group therapy frame, and therapist retention and satisfaction. SCIENTIFIC SIGNIFICANCE: Applying these strategies can aid in providing evidence-based group therapy in both clinical and research settings.

Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial.

OBJECTIVE: Medication for opioid use disorder (MOUD) improves treatment retention and reduces illicit opioid use. A-CHESS is an evidence-based smartphone intervention shown to improve addiction-related behaviors. The authors tested the efficacy of MOUD alone versus MOUD plus A-CHESS to determine whether the combination further improved outcomes. METHODS: In an unblinded parallel-group randomized controlled trial, 414 participants recruited from outpatient programs were assigned in a 1:1 ratio to receive either MOUD alone or MOUD+A-CHESS for 16 months and were followed for an additional 8 months. All participants were on methadone, buprenorphine, or injectable naltrexone. The primary outcome was abstinence from illicit opioid use; secondary outcomes were treatment retention, health services use, other substance use, and quality of life; moderators were MOUD type, gender, withdrawal symptom severity, pain severity, and loneliness. Data sources were surveys comprising multiple validated scales, as well as urine screens, every 4 months. RESULTS: There was no difference in abstinence between participants in the MOUD+A-CHESS and MOUD-alone arms across time (odds ratio=1.10, 95% CI=0.90-1.33). However, abstinence was moderated by withdrawal symptom severity (odds ratio=0.95, 95% CI=0.91-1.00) and MOUD type (odds ratio=0.57, 95% CI=0.34-0.97). Among participants without withdrawal symptoms, abstinence rates were higher over time for those in the MOUD+A-CHESS arm than for those in the MOUD-alone arm (odds ratio=1.30, 95% CI=1.01-1.67). Among participants taking methadone, those in the MOUD+A-CHESS arm were more likely to be abstinent over time (b=0.28, SE=0.09) than those in the MOUD-alone arm (b=0.06, SE=0.08), although the two groups did not differ significantly from each other (∆b=0.22, SE=0.11). MOUD+A-CHESS was also associated with greater meeting attendance (odds ratio=1.25, 95% CI=1.05-1.49) and decreased emergency department and urgent care use (odds ratio=0.88, 95% CI=0.78-0.99). CONCLUSIONS: Overall, MOUD+A-CHESS did not improve abstinence relative to MOUD alone. However, MOUD+A-CHESS may provide benefits for subsets of patients and may impact treatment utilization.

Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial.

INTRODUCTION AND BACKGROUND: Buprenorphine, and extended-release naltrexone, are effective in decreasing opioid use, morbidity and mortality. The available evidence suggests that these medications should be used for long term treatment; however, patients often ask how long they need to be on medication, and whether it would be safe to discontinue. There are sparse data to guide us. The CTN-0100 trial will address this gap in our knowledge by studying participants who have decided to discontinue buprenorphine and extended-release naltrexone for OUD. RESEARCH DESIGN AND METHODS: The trial is a multicenter, randomized, non-blinded study. Participants are stable adult volunteers, on sublingual buprenorphine, extended-release buprenorphine, or extended-release naltrexone, expressing an interest in discontinuing medication. Participants on buprenorphine must be stable for at least 1 year and participants on extended-release naltrexone must be stable for at least 6 months. Participants are engaged in the study for up to 96 weeks, including a flexible taper period, and are then transitioned to follow-up within the trial. All participants are randomly assigned to the study Medical Management (MM) or to MM plus Connections (CHESS health) digital smartphone application aimed at recovery and abstinence (MMD). Sublingual Buprenorphine participants are also randomized (2 × 2 design) to a taper using either sublingual or extended-release buprenorphine. DISCUSSION/CONCLUSION: It is hoped that this trial will provide a rich source of data on management of patients discontinuing medication for opioid use disorder (MOUD) to inform future research and practice. The trial will shed light on which strategies are most likely to lead to long-term success (absence of relapse), and what participant characteristics distinguish those who can safely discontinue MOUD from those who remain at risk of relapse should they discontinue. CLINICALTRIALS: gov Identifier: NCT04464980.

Contingency Management and Pre-Exposure Prophylaxis Adherence Support Services (CoMPASS): A hybrid type 1 effectiveness-implementation study to promote HIV risk reduction among people who inject drugs.

BACKGROUND: HIV disproportionally affects persons who inject drugs (PWID), but engagement with HIV pre-exposure prophylaxis (PrEP) is low. We describe the rationale and study design for a new study, "Contingency Management and Pre-Exposure Prophylaxis (PrEP) Adherence Support Services (CoMPASS)," a hybrid type 1 effectiveness-implementation trial to promote HIV risk reduction among PWID. METHODS: In four community-based programs in the northeastern United States, PrEP-eligible PWID (target n = 526) are randomized to treatment as usual or Contingency Management (CM) and, as indicated, stepped up to PrEP Adherence Support Services (CoMPASS) over 24 weeks. During CM sessions, participants receive timely tangible rewards for verifiable activities demonstrating 1) PrEP initiation and adherence, and 2) engagement with medications for opioid use disorder (MOUD) and other OUD-related care. Participants who do not have high levels of biomarker-confirmed PrEP adherence at week 12 will be stepped up to receive PrEP Adherence Support Services (PASS) consisting of strengths-based case management over 12 weeks. Interventions are delivered by trained PrEP navigators, staff embedded within the respective sites. The primary outcome is sustained PrEP adherence by dried blood spot testing at 24 weeks. To inform future implementation, we are conducting implementation-focused process evaluations throughout the clinical trial. CONCLUSIONS: Results from this protocol are anticipated to yield novel findings regarding the impact and scalability of CoMPASS to promote HIV prevention among PWID in partnership with community-based organizations. http://ClinicalTrials.gov identifier: NCT04738825.

Retention in care for persons with opioid use disorder transitioning from sublingual to injectable buprenorphine.

INTRODUCTION: In the current overdose epidemic, effective treatments for opioid use disorders (OUD), including innovations in medication delivery such as extended-release formulations, have the potential to improve treatment access and reduce treatment discontinuation. This study assessed treatment retention in a primary care-based, extended-release buprenorphine program. METHODS: The study recruited individuals (n = 92) who transitioned from sublingual buprenorphine to extended-release buprenorphine (BUP-XR) in 2018-2019. The study defined the primary outcome, treatment retention, as three or more consecutive, monthly BUP-XR injections following the transition to BUP-XR in this retrospective chart review. RESULTS: Participants' mean age was 38 years old and 67% were male. The average duration of sublingual buprenorphine prior to transition was 17.1 (±28.1) months. Three months after transition, 48% of extended-release buprenorphine patients had discontinued BUP-XR treatment. Persons with chronic pain were more likely, and those who had used heroin in the past month less likely to continue BUP-XR. Mean months on sublingual buprenorphine prior to BUP-XR initiation was 24.3 (±32.5) months for people who received 3+ post-induction injections compared to only 8.9 (±19.5) months for those who did not (p = .009). CONCLUSIONS: Extended-release buprenorphine discontinuation was high in a real-world setting. Retention continues to represent a major obstacle to treatment effectiveness, and programs need interventions with even newer MOUD formulations.

Negative affect-associated drug refusal self-efficacy, illicit opioid use, and medication use following short-term inpatient opioid withdrawal management.

INTRODUCTION: Persons with opioid use disorder (OUD) are prone to frequent relapse following brief inpatient medically managed withdrawal. This longitudinal, naturalistic study examines associations among illicit opioid use, use of medication for opioid use disorder (MOUD), and one's confidence in the ability to resist drug use in the face of negative emotions (i.e., negative affect-associated drug refusal self-efficacy). METHOD: Participants were 220 adults with OUD who recently completed a short-term inpatient program and the study followed for 6 months. At baseline, participants reported demographics, illicit opioid use, recent engagement with MOUD, and negative affect-associated drug refusal self-efficacy. At follow-up (1 week and 1-, 3-, and 6-months following discharge), participants reported illicit opioid use and MOUD. RESULTS: Participants averaged 30.7 years of age, 63.2% were male, and 84.1% were white. Both illicit opioid use and rates of MOUD increased during the 6-month follow-up period, although only 34.1% received MOUD. At baseline, participants reported less than 50% self-confidence to resist using opioids during negative emotional states. Baseline negative affect-associated drug refusal self-efficacy inversely predicted illicit opioid use (p = .01) at follow-up but was not associated with follow-up MOUD. CONCLUSION: Among persons with OUD, lower confidence to resist using opioids in negative emotional states predicts greater use of illicit opioids in the months following medically managed withdrawal, even with receipt of MOUD.

Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial.

CONTEXT: Limitations of existing pharmacological treatments for opioid dependence include low adherence, medication diversion, and emergence of withdrawal symptoms. OBJECTIVE: To determine the efficacy of buprenorphine implants that provide a low, steady level of buprenorphine over 6 months for the treatment of opioid dependence. DESIGN, SETTING, AND PARTICIPANTS: A randomized, placebo-controlled, 6-month trial conducted at 18 sites in the United States between April 2007 and June 2008. One hundred sixty-three adults, aged 18 to 65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants. INTERVENTION: After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients. MAIN OUTCOME MEASURE: The percentage of urine samples negative for illicit opioids for weeks 1 through 16 and for weeks 17 through 24. RESULTS: The buprenorphine implant group had significantly more urine samples negative for illicit opioids during weeks 1 through 16 (P = .04). Patients with buprenorphine implants had a mean percentage of urine samples that tested negative for illicit opioids across weeks 1 through 16 of 40.4% (95% confidence interval [CI], 34.2%-46.7%) and a median of 40.7%; whereas those in the placebo group had a mean of 28.3% (95% CI, 20.3%-36.3%) and a median of 20.8%. A total of 71 of 108 patients (65.7%) who received buprenorphine implants completed the study vs 17 of 55 (30.9%) who received placebo implants (P < .001). Those who received buprenorphine implants also had fewer clinician-rated (P <.001) and patient-rated (P = .004) withdrawal symptoms, had lower patient ratings of craving (P <.001), and experienced a greater change on clinician global ratings of severity of opioid dependence (P<.001) and on the clinician global ratings of improvement (P < .001) than those who received placebo implants. Minor implant site reactions were the most common adverse events: 61 patients (56.5%) in the buprenorphine group and 29 (52.7%) in the placebo group. CONCLUSION: Among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00447564.