Therapy and Peer Support for Opioid Use Disorder

Overseen By Brook Burkley, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Public Health Management Corporation

Must be taking: Buprenorphine

Disqualifiers: Intoxicated, Cognitively impaired, Unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

440 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David S Festinger, Ph.D.

Principal Investigator

Philadelphia College of Osteopathic Medicine

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder who are currently on medication-assisted treatment. It's designed to explore the benefits of adding psychosocial support to their regimen. Participants should be interested in how different psychological treatments can complement their current therapy.

Inclusion Criteria

Permit the research team to use and disclose their protected health information (PHI)

I am approved for buprenorphine treatment for opioid use disorder and agree to follow it.

I do not need hospitalization for my care.

Exclusion Criteria

Patients with SUD primarily for a different substance will be excluded

Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides

I do not have severe psychiatric needs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive office-based buprenorphine treatment with either standard Medication Management, CBT, CRS, or both CBT and CRS

12 months

Weekly visits until stable, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3, 6, 9, and 12 months

Treatment Details

Interventions

• Psychosocial treatment

Trial Overview The study is testing various forms of psychosocial treatment as a component of medication-assisted therapy for opioid addiction. The aim is to find out which approaches work best for different patients, moving away from generic treatments and towards more personalized care.

Participant Groups

Group I: MAT- OBOT Active Control 1 Intervention

Those randomized to MAT standard of care will continue to receive standard office-based buprenorphine treatment.

Group II: MAT+ both CBT and CRS/Peer Support Specialist Active Control 1 Intervention

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS.

Group III: MAT+ CRS/Peer Support Specialist Active Control 1 Intervention

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with a CRS.

Group IV: MAT+ office-based CBT Active Control 1 Intervention

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT.

Who Is Running the Clinical Trial?

Public Health Management Corporation

Lead Sponsor

Trials

18

Recruited

5,500+

Philadelphia College of Osteopathic Medicine

Collaborator

Trials

11

Recruited

1,300+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+