Summary

Eligibility
for people ages 21-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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 and substance misuse (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.

Official Title

Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder

Details

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.

Keywords

Chronic Pain Opioid-use Disorder Opioids; Harmful Use Opioid-Related Disorders ACT+MBRP ACT + MBRP

Eligibility

You can join if…

Open to people ages 21-75

  1. 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.
  2. Willing to comply with all study procedures and be available for the duration of the study
  3. Male or female, aged 21 to 75 years.
  4. Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics.
  5. Presence of chronic pain for > 6 months in duration.

You CAN'T join if...

  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).

Locations

  • San Francisco VA Health Care System accepting new patients
    San Francisco California 94121 United States
  • Puget Sound VA Healthcare System accepting new patients
    Tacoma Washington 98493 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of New Mexico
Links
Description of ACT+MBRP integrated treatment being tested in the current study.
ID
NCT04648228
Study Type
Interventional
Last Updated