---
title: Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes
nct_id: NCT04433975
overall_status: COMPLETED
phase: NA
sponsor: University of Michigan
study_type: INTERVENTIONAL
primary_condition: Opioid-use Disorder
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04433975.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04433975"
ct_last_update_post_date: 2025-07-09
last_seen_at: "2026-05-12T06:28:13.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

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

**NCT ID:** [NCT04433975](https://clinicaltrials.gov/study/NCT04433975)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** University of Michigan
- **Collaborators:** National Center for Complementary and Integrative Health (NCCIH), US Department of Veterans Affairs
- **Conditions:** Opioid-use Disorder, Medication Assisted Treatment, Chronic Pain
- **Start Date:** 2020-08-14
- **Completion Date:** 2025-01-19
- **CT.gov Last Update:** 2025-07-09

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

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

## Interventions

- **Psychosocial Pain Management (PPMI)** (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)** (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.

## Primary Outcomes

- **Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months** _(time frame: 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 Outcomes

- **Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months** _(time frame: 12-months post enrollment)_
- **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)** _(time frame: 3-months post enrollment)_
- **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)** _(time frame: 3-months post enrollment)_
- **Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months** _(time frame: 3-months post enrollment)_
- **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)** _(time frame: 12-months post enrollment)_
- **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)** _(time frame: 12-months post enrollment)_
- **Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months** _(time frame: 12-months post enrollment)_

## Locations (2)

- Veterans Affair Ann Arbor Healthcare System, Ann Arbor, Michigan, United States
- Michigan Medicine, Ann Arbor, Michigan, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.veterans affair ann arbor healthcare system|ann arbor|michigan|united states` — added _(2026-05-12)_
- `locations.michigan medicine|ann arbor|michigan|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04433975.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04433975*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*