Opioid Use Clinical Trial
— HEAL TogetherOfficial title:
Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD
NCT number | NCT05299515 |
Other study ID # | 1816868 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 5, 2022 |
Est. completion date | March 1, 2025 |
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Initiated methadone at the study site in the past three months (and no less than two weeks prior to study enrollment) or demonstrated challenges with methadone adherence in the past three months as indicated by one or more of the following: a) at least one missing take-home bottle at the time of bottle return; b) screened negative for methadone in routinely administered clinic urinalysis tests; c) transitioned from an extended take-home bottle schedule to daily dosing schedule; or d) at least one missed methadone dose in the past 3 months as identified through clinic records - Minimum of 18 years old Exclusion Criteria: - Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation - Inability to understand the study and provide informed consent in English - Positive pregnancy status at enrollment |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Baltimore (UMD Drug Treatment Center) | Baltimore | Maryland |
United States | University of Maryland College Park | College Park | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, College Park | Henry Ford Health System, University of Maryland, Baltimore |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in depressive symptoms | Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms. | Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline) | |
Other | Change in depressive symptoms | Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms. | Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline) | |
Other | Changes in substance use | Assess prevalence of opioid use and other substance use (urinalysis and timeline followback) | Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline) | |
Primary | MT Retention | Defined dichotomously as retention (yes/no) in methadone treatment | Measured at final follow up (approximately six-months post-baseline assessment) | |
Primary | MT Persistence | Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period) | Measured at final follow up (approximately six-months post-baseline) | |
Secondary | Intervention Feasibility Measured by Intervention Initiation | Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. We will also collect qualitative feedback relating to feasibility. | Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment) | |
Secondary | Intervention Acceptability Measured by Intervention Attendance | Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, we will measure the % of patients enrolled who attend =75% sessions. We will also collect qualitative feedback relating to acceptability. | Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment) | |
Secondary | Intervention Fidelity Measured by Independent Rating | Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and we will assess the % of intervention components delivered as intended. | Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | |
Secondary | MT Retention | Defined dichotomously as retention (yes/no) in methadone treatment | Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | |
Secondary | MT Persistence | Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period) | Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | |
Secondary | Changes in substance use | Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back) | Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline) |
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