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Pain and Opioids: Integrated Treatment In Veterans (POSITIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04648228
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : April 25, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of New Mexico

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 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid-use Disorder Opioids; Harmful Use Behavioral: ACT+MBRP Behavioral: Education control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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.
Primary Purpose: Treatment
Official Title: Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. Pain interference [ 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.

  2. Opioid misuse [ Time Frame: Post-Treatment (month 3) ]
    Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.


Secondary Outcome Measures :
  1. Pain intensity [ 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.

  2. Change in pain intensity [ 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.

  3. Depression [ 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.

  4. Change in depression [ 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.

  5. Pain-related Fear [ 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.

  6. Change in pain-related Fear [ 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.

  7. Alcohol and other drug use [ 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).

  8. Change in alcohol and other drug use [ 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).

  9. Change in Pain interference [ 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.

  10. Change in opioid misuse [ 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.


Other Outcome Measures:
  1. Social role functioning [ Time Frame: Post-Treatment (month 3) ]
    PROMIS, Social Role Functioning via 8 self-report items.

  2. Change in social role functioning [ 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.

  3. Psychosocial Impact of Illness [ Time Frame: Post-Treatment (month 3) ]
    PROMIS, Psychosocial Impact of Illness via 8 self-report items

  4. Change in psychosocial Impact of Illness [ 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

  5. Physical Functioning [ Time Frame: Post-Treatment (month 3) ]
    PROMIS, Physical Functioning via 6 self-report items

  6. Change in Physical Functioning [ Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups ]
    PROMIS, Physical Functioning via 6 self-report items

  7. Alcohol Use [ Time Frame: Post-Treatment (month 3) ]
    Alcohol Use Disorders Identification Test, 10 self-report items

  8. Change in Alcohol Use [ 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

  9. Post-Traumatic Disorder Symptoms [ Time Frame: Post-Treatment (month 3) ]
    PTSD Checklist-5, 20 self-report items

  10. Change in Post-Traumatic Disorder Symptoms [ Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups ]
    PTSD Checklist-5, 20 self-report items

  11. Generalized Anxiety [ Time Frame: Post-Treatment (month 3) ]
    Generalized Anxiety Disorders Test (GAD-7), 7 self-report items

  12. Change in Generalized Anxiety [ 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

  13. Sleep Disturbance [ Time Frame: Post-Treatment (month 3) ]
    PROMIS, Sleep Disturbance via 6 items

  14. Change in Sleep Disturbance [ Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups ]
    PROMIS, Sleep Disturbance via 6 items

  15. Pain Catastrophizing [ Time Frame: Post-Treatment (month 3) ]
    Pain Catastrophizing Scale - Short Form, 6 self-report items

  16. Change in Pain Catastrophizing [ 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

  17. Substance use [ Time Frame: Post-Treatment (month 3) ]
    Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items

  18. Change in Substance use [ 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

  19. Patient Global Impression of Change [ 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."

  20. Change in Patient Global Impression of Change [ 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."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648228


Contacts
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Contact: Katie A Witkiewitz, PhD 12062262965 katiew@unm.edu
Contact: Kevin E Vowles, PhD 447368152459 K.Vowles@qub.ac.uk

Locations
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United States, California
San Francisco VA Health Care System Recruiting
San Francisco, California, United States, 94121
Contact: Brian Borsari, PhD    415-221-4810 ext 26078    Brian.Borsari@va.gov   
United States, New Mexico
New Mexico VA Healthcare System Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Zachary Schmidt, PhD    505-265-1711 ext 6079    Zachary.Schmidt2@va.gov   
Principal Investigator: Zachary Schmidt, PhD         
Sub-Investigator: Karen Atencio, MD         
University of New Mexico Not yet recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Katie Witkiewitz, PhD    206-277-4121    katiew@unm.edu   
Principal Investigator: Katie Witkiewitz, PhD         
Sub-Investigator: Kevin Vowles, PhD         
United States, Washington
Puget Sound VA Healthcare System Recruiting
Tacoma, Washington, United States, 98493
Contact: Erik Clarke, PhD    253-583-2892    Erik.Clarke@va.gov   
Principal Investigator: Erik Clarke, PhD         
Sub-Investigator: Bernard Canlas, MD         
Sponsors and Collaborators
University of New Mexico
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
Additional Information:
Publications:
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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT04648228    
Other Study ID Numbers: 1507090
1UG3DA051241-01 ( U.S. NIH Grant/Contract )
A20-0217 ( Other Identifier: Cayuse Project Number )
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: At the time of publication of the primary manuscript, or within 12 months of last patient procedure
Access Criteria: Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy
URL: https://heal.nih.gov/about/public-access-data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders