Pain and Opioids: Integrated Treatment In Veterans

Chronic Pain Clinical Trial

— POSITIVE  

Official title:

Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648228
• Other study ID #: 1507090
• Secondary ID: 1UG3DA051241-01A
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2023
• Source: University of New Mexico
• Contact: Katie A Witkiewitz, PhD
• Phone: 12062262965
• Email: katiew[@]unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 31, 2024
• Est. primary completion date: July 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).

Related Conditions & MeSH terms

• Chronic Pain
• Opioid-Related Disorders
• Opioid-use Disorder
• Opioids; Harmful Use

Intervention

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.
• 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.

Locations

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

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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

External Links

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