Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Not Applicable

Completed

Conditions: Medication Assisted Treatment
Chronic Pain
Opioid-use Disorder

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

Recruitment & Eligibility

Status: COMPLETED

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.

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months	3-months post enrollment	In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up.

Secondary Outcome Measures

Name	Time	Method
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months	12-months post enrollment	In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 12 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 12-month follow-up.
Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 3-month Follow up (Compared to Baseline)	3-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 3-month follow-up. To calculate our measure, we subtracted each participant's score at 3-month assessment and subtracted it from their baseline score. We then averaged calculated average change in scores for each intervention group.
Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 3-month Follow up (Compared to Baseline)	3-months post enrollment	Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured 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 the 3-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score.
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months	3-months post enrollment	Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at 3-month follow-up. 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 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. Values shown are the treatment group average percent of days that participants were abstinent from substances after 3 months follow-up.
Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 12-month Follow up (Compared to Baseline)	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 12-month follow-up. For each follow-up time point, the baseline value will be subtracted to obtain a change score.
Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 12-month Follow up (Compared to Baseline)	12-months post enrollment	Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured 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 the 12-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score.
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months	12-months post enrollment	Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the 12-month follow-up. 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 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. Values shown are the treatment group average percent of days that participants were abstinent from substances after 12 months follow-up.

Trial Locations

Locations (2): Veterans Affair Ann Arbor Healthcare System
🇺🇸
Ann Arbor, Michigan, United States
Michigan Medicine
🇺🇸
Ann Arbor, Michigan, United States
Veterans Affair Ann Arbor Healthcare System
🇺🇸Ann Arbor, Michigan, United States