Project Summary

PCORI has identified treatment for opioid use disorder as an important research topic. Patients, clinicians, and others want to learn: Can counseling, support groups, and similar programs help patients who are getting medicine-based treatment for opioid use disorder? To help answer this question, PCORI launched an initiative in 2018 on Psychosocial Interventions with Office-Based Opioid Treatment (OBOT) for Opioid Use Disorder. The initiative funded this research project and others. 

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Doctors often prescribe opioids to treat chronic pain that lasts for months or years. But patients who take opioids may develop opioid use disorder, or OUD. In OUD, patients misuse, become addicted to, or take too many opioids at once. One way to treat OUD is with medicine.

Guidelines recommend that patients taking medicine for OUD also receive therapy. Cognitive behavioral therapy, or CBT, is one type of therapy for OUD. In CBT, patients learn to change patterns in their thinking and behavior. Another way to help patients taking medicine for OUD is with support from a trained peer. A peer is someone who is also in recovery from addiction and has learned skills to support other people recovering from OUD. Peers help address patients’ recovery needs. For example, they may link patients to community resources.

In this study, the research team is comparing four ways to treat OUD:

  • Medicine alone
  • Medicine plus CBT
  • Medicine plus peer support
  • Medicine plus CBT and peer support

Who can this research help?

Results may help health centers, clinicians, and patients considering ways to treat OUD.

What is the research team doing?

The research team is recruiting 440 patients who are starting to take medicine for OUD. The team is assigning patients by chance to receive one of the following:

  • Standard treatment, which involves weekly clinician visits until the patient is on a dose of medicine that keeps their OUD stable. Once patients are stable, they see the provider once a month.
  • Standard treatment plus CBT. Patients receive CBT in 12 in-person sessions along with their weekly or monthly clinician visit. During these sessions, patients learn and practice strategies such as mindfulness and tracking negative thoughts. Patients receive homework to complete between sessions.
  • Standard treatment plus peer support. Patients meet with a peer after their first visit. Peers help patients get access to community resources, overcome barriers to treatment, and go to clinic appointments regularly.  
  • Standard treatment plus CBT and peer support. Patients in this group receive medicine, CBT, and peer support, as described above.

The research team is surveying patients at the start of the study and again 3, 6, 9, and 12 months later. The team is asking patients about

  • Opioid use
  • Non-opioid drug use
  • Whether patients go to their doctor appointments for medicine management
  • Quality of life
  • Mental and social functioning
  • Trips to the emergency room, or ER
  • Overdoses
  • Patient satisfaction with treatment

The research team is also looking at medical records to see if patients go to appointments or visit the ER. They are also collecting urine samples to test for opioid and other kinds of drug use.

The research team is looking to see if these outcomes differ by the type of opioid used, and the severity of OUD. Finally, the team is asking clinicians about their satisfaction with treatments and any job stress related to treating OUD.

Policy makers, healthcare professionals, and people in recovery are helping the research team with the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 440 patients at federally qualified health centers who have an OUD and are beginning treatment with buprenorphine
Interventions/
Comparators
  • Medicine management
  • Medicine management plus CBT
  • Medicine management plus support from a certified recovery specialist
  • Medicine management plus CBT and support from a certified recovery specialist
Outcomes

Primary: opioid use

Secondary: retention in office-based opioid treatment with buprenorphine, quality of life, psychosocial functioning, abstinence from other (non-opioid) drugs, ER use, overdose, patient satisfaction, provider satisfaction, provider job stress

Timeframe 1-year follow-up for primary outcome

Engagement Resources

Project Information

David Festinger, PhD
Philadelphia College of Osteopathic Medicine
$5,536,997

Key Dates

48 months
April 2019
October 2024
2019

Study Registration Information

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Last updated: September 28, 2020