Pain and Opioids: Integrated Treatment In Veterans (POSITIVE)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid-use Disorder; Opioids; Harmful Use
• Intervention / Treatment: Behavioral: ACT+MBRP; Behavioral: Education control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie A Witkiewitz, PhD; Phone Number: 12062262965; Email: katiew@unm.edu
• Study Contact Backup: Name: Kevin E Vowles, PhD; Phone Number: 447368152459; Email: K.Vowles@qub.ac.uk

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • Recruiting
      • San Francisco VA Health Care System
      • Contact: Brian Borsari, PhD; Phone Number: 26078 415-221-4810; Email: Brian.Borsari@va.gov
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Not yet recruiting
      • University of New Mexico
      • Contact: Katie Witkiewitz, PhD; Phone Number: 206-277-4121; Email: katiew@unm.edu
      • Principal Investigator: Katie Witkiewitz, PhD
      • Sub-Investigator: Kevin Vowles, PhD
    • Albuquerque, New Mexico, United States, 87108
      • Recruiting
      • New Mexico VA Healthcare System
      • Contact: Zachary Schmidt, PhD; Phone Number: 6079 505-265-1711; Email: Zachary.Schmidt2@va.gov
      • Principal Investigator: Zachary Schmidt, PhD
      • Sub-Investigator: Karen Atencio, MD
  • Washington
    • Tacoma, Washington, United States, 98493
      • Recruiting
      • Puget Sound VA Healthcare System
      • Contact: Erik Clarke, PhD; Phone Number: 253-583-2892; Email: Erik.Clarke@va.gov
      • Principal Investigator: Erik Clarke, PhD
      • Sub-Investigator: Bernard Canlas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT + MBRP; 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.	Behavioral: ACT+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.
Active Comparator: Education Control (EC); 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.	Behavioral: Education 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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)
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
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)
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
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)
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.
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social role functioning	PROMIS, Social Role Functioning via 8 self-report items.	Post-Treatment (month 3)
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
Psychosocial Impact of Illness	PROMIS, Psychosocial Impact of Illness via 8 self-report items	Post-Treatment (month 3)
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
Physical Functioning	PROMIS, Physical Functioning via 6 self-report items	Post-Treatment (month 3)
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
Alcohol Use	Alcohol Use Disorders Identification Test, 10 self-report items	Post-Treatment (month 3)
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
Post-Traumatic Disorder Symptoms	PTSD Checklist-5, 20 self-report items	Post-Treatment (month 3)
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
Generalized Anxiety	Generalized Anxiety Disorders Test (GAD-7), 7 self-report items	Post-Treatment (month 3)
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
Sleep Disturbance	PROMIS, Sleep Disturbance via 6 items	Post-Treatment (month 3)
Change in Sleep Disturbance	PROMIS, Sleep Disturbance via 6 items	Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain Catastrophizing	Pain Catastrophizing Scale - Short Form, 6 self-report items	Post-Treatment (month 3)
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
Substance use	Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items	Post-Treatment (month 3)
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
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)
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

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: National Institute on Drug Abuse (NIDA); Johns Hopkins University; Duke University; University of California, San Francisco; Vanderbilt University; Queen's University, Belfast; University of Utah; Seattle Institute for Biomedical and Clinical Research; Biomedical Research Institute of New Mexico; San Francisco VA Health Care System

Publications and helpful links

General Publications

• 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.

Helpful Links

• Description of ACT+MBRP integrated treatment being tested in the current study.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders
• Other Study ID Numbers: 1507090; 1UG3DA051241-01 (U.S. NIH Grant/Contract); A20-0217 (Other Identifier: Cayuse Project Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is expected that all data collected by award recipients and their collaborators, as part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, will be shared with the NIH HEAL Initiative central data platform. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding.
• IPD Sharing Time Frame: At the time of publication of the primary manuscript, or within 12 months of last patient procedure
• IPD Sharing Access Criteria: Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No