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Behavioral Intervention

PRSS + TAU for Opioid Use Disorder

N/A

Recruiting

Led By Kevin R. Wenzel, Ph.D.

Research Sponsored by Potomac Health Foundations

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up re-initiation of moud is defined as re-initiation onto any moud for at least 7 days after moud dropout (defined as >14 days without moud).

Awards & highlights

Study Summary

This trial plans to test the efficacy of combining PRSS and RRs to improve MOUD retention among people with opioid use disorder.

Who is the study for?

This trial is for adults over 18 with Opioid Use Disorder (OUD) who live in a Recovery Residence (RR) and are on Medications for Opioid Use Disorder (MOUD). They must speak English, be able to consent, and not already receiving formal Peer Recovery Support Services outside of the study.Check my eligibility

What is being tested?

The study tests if adding Peer Recovery Support Services (PRSS), like recovery coaching, to usual treatment helps people stay on MOUD longer. Participants will either receive PRSS plus standard care or just standard care. The impact of PRSS on staying in treatment will be evaluated.See study design

What are the potential side effects?

Since this trial focuses on support services rather than medication, there aren't direct side effects from treatments like drugs. However, participants may experience emotional or psychological impacts as they engage with peer support during their recovery process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ re-initiation of moud is defined as re-initiation onto any moud for at least 7 days after moud dropout (defined as >14 days without moud).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~re-initiation of moud is defined as re-initiation onto any moud for at least 7 days after moud dropout (defined as >14 days without moud).

This trial's timeline: 3 weeks for screening, Varies for treatment, and re-initiation of moud is defined as re-initiation onto any moud for at least 7 days after moud dropout (defined as >14 days without moud). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

cumulative MOUD retention

Secondary outcome measures

1- continuous MOUD retention ("yes" or "no")

2- opioid relapse ("yes" or "no")

3- re-initiation of MOUD after dropout ("yes" or "no")

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 Title: Peer Recovery Support Services (PRSS) + TAUExperimental Treatment1 Intervention

Arm 2: Peer Recovery Support Services (PRSS) Intervention: The experimental group for this study that involves the implementation of the PRSS intervention. This study will test the preliminary efficacy of the PRSS intervention on Medications for Opioid Use Disorder (MOUD) retention by evenly randomizing N=50 individuals on MOUD living in recovery residences (RRs) to either a 24-week course of the experimental PRSS intervention layered on top of treatment as usual services (TAU+PRSS) vs. an active comparator composed of treatment as usual services without the PRSS intervention (i.e., TAU-alone). Follow ups will be conducted at weeks 2, 4, 8, 12, 16, 20, 24 (end of intervention), 36, and 52 to collect data on the primary outcome of MOUD retention and other outcomes.

Group II: Arm 1 Title: Treatment as Usual (TAU)Active Control1 Intervention

Arm 1: Treatment as Usual (TAU): The treatment and/or other services received as part of usual care while living in a recovery residence. This arm serves as the active comparator group for the study.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Potomac Health FoundationsLead Sponsor

4 Previous Clinical Trials

335 Total Patients Enrolled

National Institute of Drug AbuseFED

9 Previous Clinical Trials

14,469 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,800 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this clinical trial?

"The trial is actively searching for participants, with the first posting appearing on July 14th 2023 and an amendment to the listing made on September 21st of that same year according to clinicaltrials.gov."

Answered by AI

How many participants are currently included in this experiment?

"Affirmative. Details on clinicaltrials.gov signify that this medical trial, uploaded to the website on July 14th 2023, is currently enrolling participants. Two sites are needed to recruit 50 individuals for this research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Peer Recovery Support Services for Individuals in Recovery Residences on MOUD

2023. "Peer Recovery Support Services for Individuals in Recovery Residences on MOUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05616949.