A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder.

BACKGROUND AND AIMS: Although medications for opioid use disorder (OUD), including extended-release naltrexone (XR-NTX), have demonstrated effectiveness, adherence is often low. We tested the preliminary efficacy of youth opioid recovery support (YORS), a multi-component intervention designed to improve engagement and medication adherence for young adults with OUD. DESIGN: Single-site randomized controlled trial with 24-week follow-up. SETTING: Community substance use disorder treatment program in Baltimore, MD, USA. PARTICIPANTS: Young adults aged 18-26 years enrolled in inpatient/residential OUD treatment intending to pursue outpatient OUD treatment with XR-NTX. Twenty-one participants were randomized to YORS and 20 to treatment as usual (TAU). The analyzed sample was 65.8% male. INTERVENTION AND COMPARATOR: Components of YORS include: (1) home delivery of XR-NTX; (2) family engagement; (3) assertive outreach; and (4) contingency management for receipt of XR-NTX doses. The comparator was TAU, which consisted of a standard referral to outpatient care following an inpatient stay. MEASUREMENTS: Primary outcomes were number of XR-NTX doses received over 24 weeks and relapse to opioid use (defined as ≥ 10 days of use within 28 days) at 24 weeks. FINDINGS: Participants in the YORS condition received more XR-NTX doses [mean = 4.28; standard deviation (SD) = 2.3] compared with those in TAU (mean = 0.70; SD = 1.2), P < 0.01. Participants in the YORS group compared with TAU had lower rates of relapse (61 versus 95%; P < 0.01). Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition [hazard ratio (HR) = 2.72, 95% confidence interval (CI) = 1.26-5.88, P < 0.01]. CONCLUSIONS: The youth opioid recovery support intervention for extended-release naltrexone adherence and opioid relapse prevention among young adults with opioid use disorder appeared to improve treatment and relapse outcomes compared with standard treatment.

Treatment Trajectories During and After a Medication Trial for Opioid Use Disorder: Moving from Research as Usual to Treatment as Usual.

OBJECTIVES: The effectiveness of treatment incorporating relapse prevention medications for opioid use disorder (OUD) is typically examined in research using rigidly predefined endpoints of success versus failure, usually over a single episode of care. But this perspective may not adequately portray the nonlinear trajectories typical of real-world treatment courses in this chronic, remitting, and relapsing disorder. METHODS: This descriptive study examined 12-month treatment trajectories of n = 60 patients enrolled at a single site of a larger multisite randomized controlled trial examining the comparative effectiveness of buprenorphine versus extended-release naltrexone. While the parent study provided medication treatment through the research protocol for 6 months, this study documents treatment up to 12 months, including medications, provided through standard community resources (treatment as usual) outside of the protocol. RESULTS: Some patients continued medications past the end of the study intervention, whereas others did not. Some patients initiated medications other than the one assigned by the study. Some patients switched from 1 medication to the other. Many patients returned to treatment after 1 or more periods of dropout and/or relapse. Patients utilized multiple episodes of bed-based care, including short-term acute residential and long-term residential treatment, and also recovery housing supports. Described trajectories are also depicted graphically. At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%). CONCLUSIONS: This description of nonlinear treatment trajectories highlights the potential benefits of flexibility and optimism in the promotion of re-engagement, despite interim outcomes that might traditionally be considered "failure" endpoints.

Home-based delivery of XR-NTX in youth with opioid addiction.

Early experience with relapse prevention medications in the treatment of opioid addiction in youth has been positive, but barriers to effectiveness and broader adoption have included problems with adherence and retention, and lack of evidence or consensus about implementation. In particular there is relatively little known about either the effectiveness of extended release naltrexone (XR-NTX) in youth, or optimal models of care for its delivery. The purpose of this study is to report on a pilot initiative to improve the effectiveness of XR-NTX by delivering doses at home with assertive outreach to patients enrolled in a community treatment outpatient program. This is a naturalistic case series based on retrospective chart abstractions of 14 young adults (mean age=20.5), who enrolled in the pilot program, and in particular, the 9 who received home-based doses of XR-NTX. They are compared to a historical group of patients (n=21) prior to the pilot, who were referred to receive standard clinic-based doses of XR-NTX. Home-based administration was viewed favorably by patients and families. Although the small sample size is not amenable to statistical analysis, patients in the home based group, compared to the historical clinic-based group, received a greater number of doses overall and over 16 weeks of treatment, had longer retention, and attended similar numbers of clinic-based counseling sessions. These preliminary findings suggest that home-based delivery of XR-NTX and assertive outreach are feasible and promising in this critical target population, may compare favorably to clinic-based treatment as usual, and should be explored further in more rigorous evaluations.