Chronic Pain, Opioids; Harmful Use, Opioid-use Disorder
Conditions
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.
Interventions
BEHAVIORALACT+MBRP
Intervention is behavioral treatment group that combines Acceptance and Commitment Therapy (ACT) with Mindfulness-Based Relapse Prevention. The group focuses on living with long-term pain, ways to complete daily living activities when you experience pain, coping with opioid and other drug cravings, and training in mindfulness practices.
BEHAVIORALEducation control
Education control is behavioral treatment group that combines pain patient education with opioid and other drug education. The group focuses on experiences of long-term pain, instructions on how to function with this pain, and facts about opioids and other drugs.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Utah
Johns Hopkins University
Duke University
Vanderbilt University
Biomedical Research Institute of New Mexico
Seattle Institute for Biomedical and Clinical Research
Queen's University, Belfast
University of California, San Francisco
San Francisco VA Health Care System
University of New Mexico
Study design
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.
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain interference | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale. |
| Opioid misuse | Post-Treatment (month 3) | Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items. |
| Depression | Post-Treatment (month 3) | Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items. |
| Change in depression | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items. |
| Pain-related Fear | Post-Treatment (month 3) | Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items. |
| Pain intensity | Post-Treatment (month 3) | Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale. |
| Alcohol and other drug use | Post-Treatment (month 3) | Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance). |
| Change in alcohol and other drug use | Monthly. | Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance). |
| Change in Pain interference | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | 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. |
| Change in opioid misuse | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items. |
| Change in pain-related Fear | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use | Post-Treatment (month 3) | Alcohol Use Disorders Identification Test, 10 self-report items |
| Change in Alcohol Use | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Alcohol Use Disorders Identification Test, 10 self-report items |
| Post-Traumatic Disorder Symptoms | Post-Treatment (month 3) | PTSD Checklist-5, 20 self-report items |
| Change in Post-Traumatic Disorder Symptoms | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | PTSD Checklist-5, 20 self-report items |
| Social role functioning | Post-Treatment (month 3) | PROMIS, Social Role Functioning via 8 self-report items. |
| Change in Substance use | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items |
| Patient Global Impression of Change | Post-Treatment (month 3) | Patient Global Impression of Change (PGIC) is a one item measure that reflects a patient's belief about the efficacy of treatment on a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. |
| Change in Patient Global Impression of Change | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Patient Global Impression of Change (PGIC) is a one item measure that reflects a patient's belief about the efficacy of treatment on a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. |
| Generalized Anxiety | Post-Treatment (month 3) | Generalized Anxiety Disorders Test (GAD-7), 7 self-report items |
| Change in social role functioning | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | PROMIS, Social Role Functioning via 8 self-report items. |
| Change in Generalized Anxiety | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Generalized Anxiety Disorders Test (GAD-7), 7 self-report items |
| Sleep Disturbance | Post-Treatment (month 3) | PROMIS, Sleep Disturbance via 6 items |
| Change in Sleep Disturbance | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | PROMIS, Sleep Disturbance via 6 items |
| Psychosocial Impact of Illness | Post-Treatment (month 3) | PROMIS, Psychosocial Impact of Illness via 8 self-report items |
| Pain Catastrophizing | Post-Treatment (month 3) | Pain Catastrophizing Scale - Short Form, 6 self-report items |
| Change in Pain Catastrophizing | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | Pain Catastrophizing Scale - Short Form, 6 self-report items |
| Substance use | Post-Treatment (month 3) | Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items |
| Change in psychosocial Impact of Illness | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | PROMIS, Psychosocial Impact of Illness via 8 self-report items |
| Physical Functioning | Post-Treatment (month 3) | PROMIS, Physical Functioning via 6 self-report items |
| Change in Physical Functioning | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | PROMIS, Physical Functioning via 6 self-report items |
Countries
United States
Outcome results
None listed