Pain and Opioids: Integrated Treatment In Veterans (POSITIVE)

University of New Mexico (UNM)

Status: Active, not recruiting

Conditions: Opioid-use Disorder; Chronic Pain; Opioids; Harmful Use

Treatments: Behavioral: ACT+MBRP; Behavioral: Education control

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04648228

1UG3DA051241-01 (U.S. NIH Grant/Contract)

A20-0217 (Other Identifier)

1507090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 2 patient groups

ACT + MBRP

Experimental group

Description:

Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) group will follow a manualized clinical protocol. Treatment will include 12 weekly group-based sessions, each lasting 90 minutes. Group sizes will range from 3 to 8. ACT + MBRP will be delivered via the VA Video Connect telehealth platform.

Treatment:

Behavioral: ACT+MBRP

Education Control (EC)

Active Comparator group

Description:

The EC group will follow a protocol that combines opioid education sessions and psychology-led pain education sessions that are offered as part of the interdisciplinary pain program. Specifically, education will include 12 group-based sessions, each lasting 60 to 90 minutes. Group sizes will range from 3 to 8. EC will be delivered via the VA Video Connect telehealth platform.

Treatment:

Behavioral: Education control