Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Browse trials for

• Opioid-Related Disorders 1,411
• Chronic Pain 2,930

Keywords

• Psychosocial Pain Management
• Buprenorphine

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 200 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Study arms

• 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)

• Active comparator
  Enhanced Usual Care (EUC)

  Two individual telephone educational sessions with research study therapist.

  Behavioral: Enhanced Usual Care (EUC)

Interventions

• BehavioralPsychosocial 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.

• BehavioralEnhanced 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.

Primary outcomes

1. Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months

   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.

   Time frame: 3-months post enrollment

Secondary outcomes

1. Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months

   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.

   Time frame: 12-months post enrollment

2. 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)

   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.

   Time frame: 3-months post enrollment

3. 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)

   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.

   Time frame: 3-months post enrollment

4. Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months

   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.

   Time frame: 3-months post enrollment

5. 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)

   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.

   Time frame: 12-months post enrollment

6. 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)

   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.

   Time frame: 12-months post enrollment

7. Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months

   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.

   Time frame: 12-months post enrollment

Baseline characteristics

3 further baseline measures are reported on the registry.

Publications

• Ilgen M, Blow F, Piette JD, Goldstick J, Lewis M, Priest W, Matharu H, Bourgoise M, Young C, Ashe D, Price A, Lin LA. The psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Nov;158:108081. doi: 10.1016/j.cct.2025.108081. Epub 2025 Sep 17. PubMed 40972890 ↗

Study documents

• Protocol and statistical analysis plan · Nov 10, 2023
• Informed consent form · Oct 9, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No