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A randomized clinical trial of the Recovery Line among methadone treatment patients with ongoing illicit drug use.

ABSTRACT: BACKGROUND:Relapse, drug use, and treatment dropout are common challenges facing patients receiving methadone. Though effective, multiple barriers to face-to-face counseling exist. The Recovery Line (RL), an automated, self-management system based on Cognitive Behavioral Therapy, is a phone-based adjunctive treatment that provides low cost, consistent delivery and immediate therapeutic availability 24?h a day. METHODS:The current study was a 12-week randomized clinical efficacy trial of treatment-as-usual (TAU) only or RL?+?TAU for methadone treatment patients with continued illicit drug use (N?=?82). Previous small trial phases evaluated methods to increase participant engagement and use of the RL and were incorporated into the current RL version. Primary outcomes were days of self-reported illicit drug abstinence and urine screens negative for illicit drugs. RESULTS:Days of self-reported illicit drug abstinence improved for patients in RL?+?TAU but not in TAU. Percent of urine screens negative for illicit drugs, coping skills efficacy, and retention in methadone treatment did not differ by condition. Patients in RL?+?TAU attended more substance use disorder treatment and self-help group sessions during treatment than those in TAU. RL system use was generally low and more system use was correlated with abstinence outcomes. CONCLUSIONS:Although the RL did not impact urine screen outcomes, it increases self-reported abstinence. Additional methods to increase patient engagement with automated, self-management systems for substance use disorder are needed.

SUBMITTER: Moore BA

PROVIDER: S-EPMC6310054 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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A randomized clinical trial of the Recovery Line among methadone treatment patients with ongoing illicit drug use.

Moore Brent A BA Buono Frank D FD Lloyd Daniel P DP Printz Destiny M B DMB Fiellin David A DA Barry Declan T DT

Journal of substance abuse treatment 20181124

<h4>Background</h4>Relapse, drug use, and treatment dropout are common challenges facing patients receiving methadone. Though effective, multiple barriers to face-to-face counseling exist. The Recovery Line (RL), an automated, self-management system based on Cognitive Behavioral Therapy, is a phone-based adjunctive treatment that provides low cost, consistent delivery and immediate therapeutic availability 24 h a day.<h4>Methods</h4>The current study was a 12-week randomized clinical efficacy tr ...[more]

PMID: 30577901

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Project description:ImportanceMethadone treatment is the most effective evidence-based treatment for opioid use disorder (OUD), but challenges related to dosing and premature treatment dropout argue for adjunct interventions to improve outcomes. One potential behavioral intervention with low risk involves harnessing placebo effects.ObjectiveTo determine the effect of a pharmacologically conditioned open-label placebo (C-OLP) on 90-day methadone dose, retention, drug use, withdrawal, craving, quality of life, and sleep.Design, setting, and participantsThis 2-arm, open-label, single-blind randomized clinical trial was conducted between December 5, 2017, and August 2, 2019, in an academically affiliated community opioid treatment program. Analyses were conducted between October 1, 2019, and April 30, 2020. A total of 320 newly enrolled adults seeking treatment for moderate to severe OUD were assessed for study eligibility; 131 met eligibility criteria, provided informed consent, and were randomized to either C-OLP or treatment as usual (TAU) in an unequal-block (3:2) manner. Exclusion criteria were pregnancy, hospital/program transfers, and court-ordered treatment.InterventionsParticipants randomized to C-OLP received pharmacologic conditioning and a placebo pill and methadone, and participants randomized to TAU were given methadone only. Participants met with the study team 5 times: at baseline (treatment intake) and 2, 4, 8, and 12 weeks postbaseline. Interactions were balanced between the 2 groups.Main outcomes and measuresOutcomes included 90-day methadone dose (primary) and treatment retention, drug use, withdrawal, craving, quality of life, and sleep quality (secondary). Analyses were conducted as intention-to-treat.ResultsOf the 131 people enrolled in the study, 54 were randomized to TAU and 77 to C-OLP. Mean (SD) age was 45.9 (11.2) years; most of the participants were Black or African American (83 [63.4%]) and male (84 [64.1%]). No significant group differences were observed in the mean (SD) 90-day methadone dose (83.1 [25.1] mg for group TAU, 79.4 [19.6] mg for group C-OLP; t = 0.621991; P = .43), but the groups differed significantly in their retention rates: 33 (61.1%) for TAU and 60 (77.9%) for C-OLP (χ21 = 4.356; P = .04; number needed to treat for the beneficial outcome of 3-month treatment retention, 6; 95% CI, 4-119). C-OLP participants also reported significantly better sleep quality.Conclusions and relevanceIn this randomized clinical trial, C-OLP had no effect on the primary outcome of 90-day methadone dose. However, C-OLP participants were significantly more likely to remain in treatment. These findings support the use of C-OLP as a methadone treatment adjunct, but larger trials are needed to further examine the use of C-OLP.Trial registrationClinicalTrials.gov Identifier: NCT02941809.

Dataset Information

A randomized clinical trial of the Recovery Line among methadone treatment patients with ongoing illicit drug use.

Publications

A randomized clinical trial of the Recovery Line among methadone treatment patients with ongoing illicit drug use.

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