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Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder

NCT06359340 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-08-06

No results posted yet for this study

Summary

Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, the investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined.

Conditions

  • Opioid-use Disorder

Interventions

BEHAVIORAL

Psychosocial treatment

Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.

Sponsors & Collaborators

  • Boston University

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Philadelphia College of Osteopathic Medicine

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • Public Health Management Corporation

    lead OTHER

Principal Investigators

  • David S Festinger, Ph.D. · Philadelphia College of Osteopathic Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2025-05-30
Completion
2026-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359340 on ClinicalTrials.gov