Chronic Pain Clinical Trial
— POSITIVEOfficial title:
Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | November 30, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | New Mexico VA Healthcare System | Albuquerque | New Mexico |
United States | University of New Mexico | Albuquerque | New Mexico |
United States | San Francisco VA Health Care System | San Francisco | California |
United States | Puget Sound VA Healthcare System | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico | Biomedical Research Institute of New Mexico, Duke University, Johns Hopkins University, National Institute on Drug Abuse (NIDA), Queen's University, Belfast, San Francisco VA Health Care System, Seattle Institute for Biomedical and Clinical Research, University of California, San Francisco, University of Utah, Vanderbilt University |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Social role functioning | PROMIS, Social Role Functioning via 8 self-report items. | Post-Treatment (month 3) | |
Other | Change in social role functioning | PROMIS, Social Role Functioning via 8 self-report items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Psychosocial Impact of Illness | PROMIS, Psychosocial Impact of Illness via 8 self-report items | Post-Treatment (month 3) | |
Other | Change in psychosocial Impact of Illness | PROMIS, Psychosocial Impact of Illness via 8 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Physical Functioning | PROMIS, Physical Functioning via 6 self-report items | Post-Treatment (month 3) | |
Other | Change in Physical Functioning | PROMIS, Physical Functioning via 6 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Alcohol Use | Alcohol Use Disorders Identification Test, 10 self-report items | Post-Treatment (month 3) | |
Other | Change in Alcohol Use | Alcohol Use Disorders Identification Test, 10 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Post-Traumatic Disorder Symptoms | PTSD Checklist-5, 20 self-report items | Post-Treatment (month 3) | |
Other | Change in Post-Traumatic Disorder Symptoms | PTSD Checklist-5, 20 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Generalized Anxiety | Generalized Anxiety Disorders Test (GAD-7), 7 self-report items | Post-Treatment (month 3) | |
Other | Change in Generalized Anxiety | Generalized Anxiety Disorders Test (GAD-7), 7 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Sleep Disturbance | PROMIS, Sleep Disturbance via 6 items | Post-Treatment (month 3) | |
Other | Change in Sleep Disturbance | PROMIS, Sleep Disturbance via 6 items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Pain Catastrophizing | Pain Catastrophizing Scale - Short Form, 6 self-report items | Post-Treatment (month 3) | |
Other | Change in Pain Catastrophizing | Pain Catastrophizing Scale - Short Form, 6 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Substance use | Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items | Post-Treatment (month 3) | |
Other | Change in Substance use | Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Other | Patient Global Impression of Change | 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." | Post-Treatment (month 3) | |
Other | Change in Patient Global Impression of Change | 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." | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Primary | Pain interference | 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. | Post-Treatment (month 3) | |
Primary | Opioid misuse | Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items. | Post-Treatment (month 3) | |
Secondary | Pain intensity | 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. | Post-Treatment (month 3) | |
Secondary | Change in pain intensity | 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. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Secondary | Depression | Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items. | Post-Treatment (month 3) | |
Secondary | Change in depression | Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Secondary | Pain-related Fear | Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items. | Post-Treatment (month 3) | |
Secondary | Change in pain-related Fear | Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Secondary | Alcohol and other drug use | 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). | Post-Treatment (month 3) | |
Secondary | Change in alcohol and other drug use | 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). | Monthly. | |
Secondary | Change in Pain interference | 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. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups | |
Secondary | Change in opioid misuse | Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
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