Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Not Applicable

Active, not recruiting

• Conditions: Medication Assisted Treatment; Chronic Pain; Opioid-use Disorder
• Interventions: Behavioral: Psychosocial Pain Management (PPMI); Behavioral: Enhanced Usual Care (EUC)

• Registration Number: NCT04433975
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2020-08-14
• Primary Completion: 2024-05-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychosocial Pain Management (PPMI)	Psychosocial Pain Management (PPMI)	Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.
Enhanced Usual Care (EUC)	Enhanced Usual Care (EUC)	Two individual telephone educational sessions with research study therapist.

Primary Outcome Measures

Name	Time	Method
Retention on buprenorphine treatment according to TimeLine Follow-Back	Up to 3-months post enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Retention on buprenorphine treatment according to TimeLine Follow-Back	Up to 12-months post enrollment	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.
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).	Up to 12-months post enrollment	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.
Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)	Up to 12-months post enrollment	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.
Change from baseline in self-reported level of pain related functioning on the Pain Interference measure	Up to 12-months post enrollment	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.
Percent days abstinent from substance use on the TimeLine Follow-Back	Up to 12-months post enrollment	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.

Trial Locations

Locations (2)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States

Veterans Affair Ann Arbor Healthcare System; 🇺🇸 Ann Arbor, Michigan, United States