Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Study Overview
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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.

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

Conditions
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Opioid-use Disorder, Medication Assisted Treatment, Chronic Pain

Intervention / Treatment
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* Behavioral: Psychosocial Pain Management (PPMI)
* Behavioral: Enhanced Usual Care (EUC)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial Pain Management (PPMI)<br>Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. | Behavioral: Psychosocial Pain Management (PPMI)<br>* 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.<br>|
| Active Comparator: Enhanced Usual Care (EUC)<br>Two individual telephone educational sessions with research study therapist. | Behavioral: Enhanced Usual Care (EUC)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosocial Pain Management, Buprenorphine