Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes (Persist)

Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial

The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; Medication Assisted Treatment; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Psychosocial Pain Management (PPMI); Behavioral: Enhanced Usual Care (EUC)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mandy Lewis, MS; Phone Number: 734-474-0702; Email: mstinchc@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine
    • Ann Arbor, Michigan, United States, 48105
      • Veterans Affair Ann Arbor Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• having a diagnosis of an opioid use disorders (OUD) within the past 12 months;
• started buprenorphine (the term we use to refer to all buprenorphine products including buprenorphine/naloxone) treatment within the past 6 months
• at least moderate or greater self-reported pain on average over the past 3 months;
• regular and consistent access to a telephone and willingness to use the phone for study sessions.

Exclusion Criteria:

• buprenorphine medication prescribed in the form of a monthly injection and/or a transdermal patch
• self-reported pregnancy at the time of study enrollment
• currently living outside of the United States

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychosocial Pain Management (PPMI); Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.	Behavioral: Psychosocial Pain Management (PPMI); The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Active Comparator: Enhanced Usual Care (EUC); Two individual telephone educational sessions with research study therapist.	Behavioral: Enhanced Usual Care (EUC); The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention on buprenorphine treatment according to TimeLine Follow-Back	Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1- and 3-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.	Up to 3-months post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention on buprenorphine treatment according to TimeLine Follow-Back	Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.	Up to 12-months post enrollment
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).	Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 1- and 3--month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.	Up to 3-months post enrollment
Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)	Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at each follow-up (1- and 3-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.	Up to 3-months post enrollment
Change from baseline in self-reported level of pain related functioning on the Pain Interference measure	Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1- and 3-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.	Up to 3-months post enrollment
Percent days abstinent from substance use on the TimeLine Follow-Back	Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1- and 3-month follow-ups. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use.	Up to 3-months post enrollment
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).	Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.	Up to 12-months post enrollment
Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)	Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at each follow-up (1-, 3-, 6-, 9-, and 12-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.	Up to 12-months post enrollment
Change from baseline in self-reported level of pain related functioning on the Pain Interference measure	Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1-, 3-, 6-, 9-, and 12-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.	Up to 12-months post enrollment
Percent days abstinent from substance use on the TimeLine Follow-Back	Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use.	Up to 12-months post enrollment

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: US Department of Veterans Affairs; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Allison Lin, M.D., M.S., University of Michigan; Principal Investigator: Mark Ilgen, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Buprenorphine; Psychosocial Pain Management
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Substance-Related Disorders; Chronic Pain; Opioid-Related Disorders
• Other Study ID Numbers: HUM00166747; R33AT010106 (U.S. NIH Grant/Contract); R01AT010797 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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