Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2025-01-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid-use Disorder Medication Assisted Treatment Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Psychosocial Pain Management (PPMI)

Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.

Group Type EXPERIMENTAL

Psychosocial Pain Management (PPMI)

Intervention Type BEHAVIORAL

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.

Enhanced Usual Care (EUC)

Two individual telephone educational sessions with research study therapist.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No