Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of New Mexico
- Enrollment
- 157
- Locations
- 8
- Primary Endpoint
- Pain interference
Study Overview
Brief Summary
This trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention [ACT + MBRP]) compared to an education control (EC) consisting of a protocol-based series of education sessions concerning chronic pain, opioids, and buprenorphine use and (2) examine how theoretically-relevant treatment mechanisms of pain acceptance, engagement in values-based action, and opioid craving are related to treatment outcomes. Interventions will be delivered via the VA Video Connect telehealth modality.
Detailed Description
There is compelling data that chronic pain and hazardous opioid use, considered individually, are significant and costly healthcare burdens in both veteran and nonveteran populations in the United States (US). When these two diagnoses are considered together, they appear to occur in a clinically significant proportion of patients. Further, opioid use disorder (OUD) interferes with chronic pain treatment outcomes and continued pain interferes with OUD outcomes treatment. While buprenorphine is effective for the treatment of pain and OUD, retention, relapse, and continued pain interference is not addressed through treatment with buprenorphine alone. Integrated treatments that target the key outcomes for both conditions, specifically pain's interference on functioning and opioid misuse/relapse, as developed in our prior work, allows for a parsimonious and efficacious way of providing treatment. Our recently completed pilot study indicated that such an integrated treatment was feasible and more effective than treatment as usual. To study this further, a multisite clinical trial comparing a three month integrated behavioral treatment that combines Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, as compared to an education control will be conducted with 160 veterans recruited from three VA Health Care Systems who have been stabilized on buprenorphine for the treatment of OUD. To assess longer-term outcomes, participants will be followed for 1 year after completion of the 3 month intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Principal Investigators will be blinded. Co-investigators and study physicians involved in the treatment and control conditions will not be blinded, as these individuals will handle the delivery of treatment. The study coordinators located within each VA will not be blinded, as they will be involved in coordinating participant screening and randomization. Data analysis will be conducted by a study statistician blinded to participant condition.
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stabilized on a dose of buprenorphine for a period of at least 1 month and less than six months. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female, aged 21 to 75 years.
- •Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics.
- •Presence of chronic pain for > 6 months in duration.
Exclusion Criteria
- •Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
- •Unable to read English.
- •Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
Outcomes
Primary Outcomes
Pain interference
Time Frame: Post-Treatment (month 3)
Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items.
Secondary Outcomes
- Pain intensity(Post-Treatment (month 3))
- Change in pain intensity(Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups)
- Opioid misuse(Post-Treatment (month 3))
- Depression(Post-Treatment (month 3))
- Change in depression(Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups)
- Pain-related Fear(Post-Treatment (month 3))
- Change in pain-related Fear(Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups)
- Alcohol and other drug use(Post-Treatment (month 3))
- Change in alcohol and other drug use(Monthly.)
- Change in Pain interference(Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups)
- Change in opioid misuse(Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups)