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Pain and Opioids: Integrated Treatment In Veterans (POSITIVE)

Primary Purpose

Chronic Pain, Opioid-use Disorder, Opioids; Harmful Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT+MBRP
Education control
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • San Francisco VA Health Care SystemRecruiting
  • New Mexico VA Healthcare SystemRecruiting
  • University of New Mexico
  • Puget Sound VA Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT + MBRP

Education Control (EC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Opioid misuse
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.

Secondary Outcome Measures

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.
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.
Depression
Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items.
Change in depression
Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items.
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.
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.
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).
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).
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.
Change in opioid misuse
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.

Full Information

First Posted
June 18, 2020
Last Updated
May 9, 2023
Sponsor
University of New Mexico
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
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1. Study Identification

Unique Protocol Identification Number
NCT04648228
Brief Title
Pain and Opioids: Integrated Treatment In Veterans
Acronym
POSITIVE
Official Title
Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid-use Disorder, Opioids; Harmful Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACT + MBRP
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Control (EC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ACT+MBRP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education control
Intervention Description
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 Measure Information:
Title
Pain interference
Description
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)
Title
Opioid misuse
Description
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.
Time Frame
Post-Treatment (month 3)
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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)
Title
Change in pain intensity
Description
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
Title
Depression
Description
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)
Title
Change in depression
Description
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
Title
Pain-related Fear
Description
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)
Title
Change in pain-related Fear
Description
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
Title
Alcohol and other drug use
Description
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
Post-Treatment (month 3)
Title
Change in alcohol and other drug use
Description
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.
Title
Change in Pain interference
Description
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
Title
Change in opioid misuse
Description
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.
Time Frame
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Other Pre-specified Outcome Measures:
Title
Social role functioning
Description
PROMIS, Social Role Functioning via 8 self-report items.
Time Frame
Post-Treatment (month 3)
Title
Change in social role functioning
Description
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
Title
Psychosocial Impact of Illness
Description
PROMIS, Psychosocial Impact of Illness via 8 self-report items
Time Frame
Post-Treatment (month 3)
Title
Change in psychosocial Impact of Illness
Description
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
Title
Physical Functioning
Description
PROMIS, Physical Functioning via 6 self-report items
Time Frame
Post-Treatment (month 3)
Title
Change in Physical Functioning
Description
PROMIS, Physical Functioning via 6 self-report items
Time Frame
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Title
Alcohol Use
Description
Alcohol Use Disorders Identification Test, 10 self-report items
Time Frame
Post-Treatment (month 3)
Title
Change in Alcohol Use
Description
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
Title
Post-Traumatic Disorder Symptoms
Description
PTSD Checklist-5, 20 self-report items
Time Frame
Post-Treatment (month 3)
Title
Change in Post-Traumatic Disorder Symptoms
Description
PTSD Checklist-5, 20 self-report items
Time Frame
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Title
Generalized Anxiety
Description
Generalized Anxiety Disorders Test (GAD-7), 7 self-report items
Time Frame
Post-Treatment (month 3)
Title
Change in Generalized Anxiety
Description
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
Title
Sleep Disturbance
Description
PROMIS, Sleep Disturbance via 6 items
Time Frame
Post-Treatment (month 3)
Title
Change in Sleep Disturbance
Description
PROMIS, Sleep Disturbance via 6 items
Time Frame
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale - Short Form, 6 self-report items
Time Frame
Post-Treatment (month 3)
Title
Change in Pain Catastrophizing
Description
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
Title
Substance use
Description
Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items
Time Frame
Post-Treatment (month 3)
Title
Change in Substance use
Description
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
Title
Patient Global Impression of Change
Description
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
Post-Treatment (month 3)
Title
Change in Patient Global Impression of Change
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Willing to comply with all study procedures and be available for the duration of the study Male or female, aged 21 to 75 years. Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics. Presence of chronic pain for > 6 months in duration. Exclusion Criteria: Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders. Unable to read English. Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie A Witkiewitz, PhD
Phone
12062262965
Email
katiew@unm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin E Vowles, PhD
Phone
447368152459
Email
K.Vowles@qub.ac.uk
Facility Information:
Facility Name
San Francisco VA Health Care System
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Borsari, PhD
Phone
415-221-4810
Ext
26078
Email
Brian.Borsari@va.gov
Facility Name
New Mexico VA Healthcare System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Schmidt, PhD
Phone
505-265-1711
Ext
6079
Email
Zachary.Schmidt2@va.gov
First Name & Middle Initial & Last Name & Degree
Zachary Schmidt, PhD
First Name & Middle Initial & Last Name & Degree
Karen Atencio, MD
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Witkiewitz, PhD
Phone
206-277-4121
Email
katiew@unm.edu
First Name & Middle Initial & Last Name & Degree
Katie Witkiewitz, PhD
First Name & Middle Initial & Last Name & Degree
Kevin Vowles, PhD
Facility Name
Puget Sound VA Healthcare System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98493
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Clarke, PhD
Phone
253-583-2892
Email
Erik.Clarke@va.gov
First Name & Middle Initial & Last Name & Degree
Erik Clarke, PhD
First Name & Middle Initial & Last Name & Degree
Bernard Canlas, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://heal.nih.gov/about/public-access-data
Citations:
PubMed Identifier
31760109
Citation
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.
Results Reference
background
Links:
URL
https://doi.org/10.1016/j.jpain.2019.11.007
Description
Description of ACT+MBRP integrated treatment being tested in the current study.

Learn more about this trial

Pain and Opioids: Integrated Treatment In Veterans

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