Clinical trial NCT04648228: Pain and Opioids: Integrated Treatment In Veterans
Official title: Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid-use Disorder
Opioids; Harmful Use
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Utah
name: Johns Hopkins University
name: Duke University
name: Vanderbilt University
name: Biomedical Research Institute of New Mexico
name: Seattle Institute for Biomedical and Clinical Research
name: Queen's University, Belfast
name: University of California, San Francisco
name: San Francisco VA Health Care System
First posted: 2020-12-01
Enrollment: 157
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial will determine the efficacy of an integrated Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention (ACT+MBRP) treatment program for veterans with co-occurring chronic pain and opioid use disorder (OUD) who are prescribed buprenorphine, compared to an education control (EC) consisting of pain, opioid, and buprenorphine education. To test the efficacy of ACT + MBRP compared to EC with regard to primary and secondary outcomes, participants will be randomized to one of 2 treatment arms and followed for a total of 15 months (3-month active treatment period, 6 month follow-up, 12 month follow-up). All study treatments will be delivered via the VA Video Connect telehealth platform.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain interference
timeFrame: Post-Treatment (month 3)
Secondary outcomes:
measure: Pain intensity
timeFrame: Post-Treatment (month 3)
measure: Change in pain intensity
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Opioid misuse
timeFrame: Post-Treatment (month 3)
measure: Depression
timeFrame: Post-Treatment (month 3)
measure: Change in depression
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Pain-related Fear
timeFrame: Post-Treatment (month 3)
measure: Change in pain-related Fear
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Alcohol and other drug use
timeFrame: Post-Treatment (month 3)
measure: Change in alcohol and other drug use
timeFrame: Monthly.
measure: Change in Pain interference
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Change in opioid misuse
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Other outcomes:
measure: Social role functioning
timeFrame: Post-Treatment (month 3)
measure: Change in social role functioning
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Psychosocial Impact of Illness
timeFrame: Post-Treatment (month 3)
measure: Change in psychosocial Impact of Illness
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Physical Functioning
timeFrame: Post-Treatment (month 3)
measure: Change in Physical Functioning
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Alcohol Use
timeFrame: Post-Treatment (month 3)
measure: Change in Alcohol Use
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Post-Traumatic Disorder Symptoms
timeFrame: Post-Treatment (month 3)
measure: Change in Post-Traumatic Disorder Symptoms
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Generalized Anxiety
timeFrame: Post-Treatment (month 3)
measure: Change in Generalized Anxiety
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Sleep Disturbance
timeFrame: Post-Treatment (month 3)
measure: Change in Sleep Disturbance
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Pain Catastrophizing
timeFrame: Post-Treatment (month 3)
measure: Change in Pain Catastrophizing
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Substance use
timeFrame: Post-Treatment (month 3)
measure: Change in Substance use
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
measure: Patient Global Impression of Change
timeFrame: Post-Treatment (month 3)
measure: Change in Patient Global Impression of Change
timeFrame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Health Care System
state: California
city: Albuquerque
country: United States
facility: New Mexico VA Healthcare System
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Tacoma
country: United States
facility: Puget Sound VA Healthcare System
state: Washington
Study officials:
References:
citation: Vowles KE, Witkiewitz K, Cusack KJ, Gilliam WP, Cardon KE, Bowen S, Edwards KA, McEntee ML, Bailey RW. Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. J Pain. 2020 Jul-Aug;21(7-8):798-807. doi: 10.1016/j.jpain.2019.11.007. Epub 2019 Nov 21.