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Peer-Delivered Behavioral Activation for Opioid Addiction (HEAL Together Trial)

N/A
Recruiting
Led By Jessica F Magidson, PhD
Research Sponsored by University of Maryland, College Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum of 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if trained peers can help low-income, minority individuals with opioid addiction stick to their medication by encouraging positive activities. The goal is to see if this approach improves medication adherence.

Who is the study for?
This trial is for adults over 18 in Baltimore with opioid use disorder who have started methadone treatment at the study site within the last three months or have had trouble sticking to their methadone regimen. It's not for those with untreated severe mental health issues, non-English speakers, or pregnant individuals.
What is being tested?
The 'Peer Activate' program, led by peer recovery specialists using behavioral activation techniques, aims to improve how well participants stick to their medication-assisted treatment for opioid addiction compared to usual care. The effectiveness and implementation will be studied over six months.
What are the potential side effects?
Since this intervention involves behavioral support rather than medication, there are no direct medical side effects. However, participants may experience emotional discomfort when discussing personal issues related to drug use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Intervention Acceptability Measured by Intervention Attendance
Intervention Feasibility Measured by Intervention Initiation
Intervention Fidelity Measured by Independent Rating
+2 more
Other study objectives
Change in depressive symptoms
Changes in substance use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Peer-Delivered Behavioral Activation ("Peer Activate")Experimental Treatment1 Intervention
Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention.
Group II: Treatment As UsualActive Control1 Intervention
Participants in the TAU group will receive treatment as usual (weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Behavioral activation (BA) is a therapeutic approach used in treating Opioid Use Disorder (OUD) that focuses on increasing patients' engagement in meaningful activities to counteract the negative effects of addiction. By helping patients identify and participate in activities aligned with their values and interests, BA improves mood and reduces reliance on opioids. This approach can be combined with other treatments like Cognitive Behavioral Therapy (CBT) and Contingency Management (CM), which modify harmful behaviors and reinforce positive behaviors through incentives. These treatments are essential for OUD patients as they address both psychological and behavioral aspects of addiction, promoting long-term recovery and enhancing overall quality of life.

Find a Location

Who is running the clinical trial?

University of Maryland, College ParkLead Sponsor
159 Previous Clinical Trials
46,263 Total Patients Enrolled
Henry Ford Health SystemOTHER
311 Previous Clinical Trials
2,176,193 Total Patients Enrolled
University of Maryland, BaltimoreOTHER
716 Previous Clinical Trials
380,909 Total Patients Enrolled
Jessica F Magidson, PhDPrincipal InvestigatorUniversity of Maryland, College Park
5 Previous Clinical Trials
354 Total Patients Enrolled

Media Library

Peer-Delivered Behavioral Activation Clinical Trial Eligibility Overview. Trial Name: NCT05299515 — N/A
Opioid Use Disorder Research Study Groups: Peer-Delivered Behavioral Activation ("Peer Activate"), Treatment As Usual
Opioid Use Disorder Clinical Trial 2023: Peer-Delivered Behavioral Activation Highlights & Side Effects. Trial Name: NCT05299515 — N/A
Peer-Delivered Behavioral Activation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05299515 — N/A
~27 spots leftby Jun 2025