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AimsTo evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX).DesignRandomized, double-blind, placebo-controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open-label BNX (12-16 mg/day) (n = 119).SettingTwenty addiction treatment centers.ParticipantsAdult out-patients (ages 18-65) with DSM-IV-TR opioid dependence.MeasurementsThe primary efficacy end-point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).FindingsThe BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician-rated (P < 0.0001) and patient-rated (P < 0.0001) withdrawal, lower patient-ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant-site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non-inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (-10.7, 6.2)].ConclusionsCompared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non-inferior to sublingual buprenorphine/naloxone tablets.

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. 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. 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). 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. [ABSTRACT FROM AUTHOR]

A study was conducted to evaluate the efficacy and safety of buprenorphine implants as a form of treatment for individuals with opioid dependence. Results indicated that in the use of such implants resulted in less opioid use over 16 weeks.

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). [ABSTRACT FROM AUTHOR]