NCT Number: NCT04648228
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.
This study is active but is not currently recruiting participants.
21 year–75 year
All sexes
Interventional
Not applicable
San Francisco VA Health Care System, San Francisco, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Treatment (month 3)
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.
Time frame: Post-Treatment (month 3)
Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Post-Treatment (month 3)
PROMIS, Social Role Functioning via 8 self-report items.
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Social Role Functioning via 8 self-report items.
Time frame: Post-Treatment (month 3)
PROMIS, Psychosocial Impact of Illness via 8 self-report items
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Psychosocial Impact of Illness via 8 self-report items
Time frame: Post-Treatment (month 3)
PROMIS, Physical Functioning via 6 self-report items
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Physical Functioning via 6 self-report items
Time frame: Post-Treatment (month 3)
Alcohol Use Disorders Identification Test, 10 self-report items
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Alcohol Use Disorders Identification Test, 10 self-report items
Time frame: Post-Treatment (month 3)
PTSD Checklist-5, 20 self-report items
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PTSD Checklist-5, 20 self-report items
Time frame: Post-Treatment (month 3)
Generalized Anxiety Disorders Test (GAD-7), 7 self-report items
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Generalized Anxiety Disorders Test (GAD-7), 7 self-report items
Time frame: Post-Treatment (month 3)
PROMIS, Sleep Disturbance via 6 items
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Sleep Disturbance via 6 items
Time frame: Post-Treatment (month 3)
Pain Catastrophizing Scale - Short Form, 6 self-report items
Time frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain Catastrophizing Scale - Short Form, 6 self-report items
Time frame: Post-Treatment (month 3)
Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items
Time frame: 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
Time frame: 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."
Time frame: 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."
University of New Mexico
Other
Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
Acronym: POSITIVE
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