What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

The most common treatments for Opioid Use Disorder (OUD) include medications such as buprenorphine, methadone, and naltrexone, often combined with behavioral interventions like Cognitive Behavioral Therapy (CBT) and Behavioral Activation (BA). Buprenorphine can cause side effects such as constipation, headache, nausea, and sweating. Methadone's side effects include respiratory depression, constipation, and potential for dependency. Naltrexone may cause nausea, headache, dizziness, and fatigue. Behavioral interventions like BA, which are being studied in the Peer Activate trial, generally have fewer physical side effects but may involve emotional and psychological challenges as patients work through their substance use issues.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including buprenorphine, methadone, and naltrexone. Buprenorphine is available in various formulations such as sublingual tablets and buccal films, while methadone is typically administered in specialized clinics. Naltrexone, an opioid receptor antagonist, is available in oral and extended-release injectable forms. These medications are often used in conjunction with behavioral therapies to enhance treatment outcomes. The Peer Activate trial focuses on a peer-led behavioral activation intervention to improve adherence to medication for OUD, highlighting the importance of combining pharmacotherapy with behavioral support.

What other types of research exist?

Promising, novel alternatives to Peer Activate for OUD patients include: 1) Patient-centered home-based buprenorphine inductions, which offer a more flexible and patient-driven approach compared to standard office-based inductions. 2) Video directly observed therapy (DOT) for buprenorphine, which uses a HIPAA-compliant smartphone application to improve adherence and outcomes. 3) Rapid transition protocols from methadone to buprenorphine using micro-dosing, which have demonstrated feasibility and cost-effectiveness in outpatient settings.

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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 between the baseline assessment and the final follow-up (approximately 6 months post-baseline)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline) 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).

0 / 1Eligibility criteria met

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.