CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 125 enrolled
Drug / intervention
Psychosocial support determined by adaptive treatment algorithmbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04650386
NCT04650386N/ACompleted

Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach

Public Health Management Corporation·interventional·Posted Dec 2, 2020·Updated Nov 6, 2024

In Brief

A clinical study evaluating Psychosocial support determined by adaptive treatment algorithm for Opioid-use Disorder. Completed, enrolled 125 participants across 2 sites.

Detailed Summary

The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 2, 2020
Enrollment StartSep 21, 2020
Primary CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.6 years ago

Interventions

Psychosocial support determined by adaptive treatment algorithmbehavioral

Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.