A treatment to help people with chronic pain and opioid use disorder
Integrative Treatment for Achieving Holistic Recovery From Comorbid Chronic Pain and Opioid Use Disorder
This study is testing a new treatment that combines therapy techniques to see if it can help people with chronic pain and opioid use disorder feel better and avoid relapse compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of New Mexico Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT05571917 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a treatment designed to reduce pain interference while preventing relapse in individuals with both chronic pain and Opioid Use Disorder (OUD). Approximately 160 participants will be recruited from clinics specializing in OUD management and will be stabilized on buprenorphine as part of their usual care. Participants will be randomly assigned to receive either enhanced usual care or an integrated treatment combining Acceptance and Commitment Therapy (ACT) and Mindfulness Based Relapse Prevention (MBRP). The study aims to determine if the integrated approach is more effective in reducing pain and opioid misuse compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been stabilized on buprenorphine for at least one month and have chronic pain lasting more than six months.
Not a fit: Patients with severe substance use disorders requiring inpatient care or those with certain psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from both chronic pain and opioid use disorder.
How similar studies have performed: Previous pilot studies have shown promising results by integrating ACT and MBRP for similar patient populations, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Stabilized on a dose of buprenorphine for a period of at least 1 month. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days. 2. Willing to comply with all study procedures and be available for the duration of the study. 3. Aged 18 years or older. 4. Enrolled as a patient in one of the participating clinics. 5. Presence of chronic pain for \> 6 months in duration. Exclusion Criteria: 1. Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders. 2. Unable to read English. 3. Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Katie Witkiewitz, PhD — University of New Mexico
- Study coordinator: Katie Witkiewitz, PhD
- Email: katiew@unm.edu
- Phone: (505) 585-1686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.