Opioid-use DisorderPersistNCT04433975
Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes
A study testing Psychosocial Pain Management (PPMI) in people with Opioid-use Disorder and Medication Assisted Treatment, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Medication Assisted Treatment, Chronic Pain
- What is being tested?
- Psychosocial Pain Management (PPMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2020to 19 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affair Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Michigan Medicine
Ann Arbor, Michigan, 48109
About this study
Official title: Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial
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.
- Being tested
- Psychosocial Pain Management (PPMI), Enhanced Usual Care (EUC)
- Keywords
- Psychosocial Pain Management, Buprenorphine
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Pain Management (PPMI)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial Pain Management (PPMI) | Experimental | Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Receives: Behavioral: Psychosocial Pain Management (PPMI) |
| Enhanced Usual Care (EUC) | Active comparator | Two individual telephone educational sessions with research study therapist. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months post enrollment
Secondary outcomes (7)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 3-months post enrollment
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 12-months post enrollment
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.
Measured: 12-months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start14 Aug 2020
- Primary completion23 May 2024
- Study completion19 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), US Department of Veterans Affairs
- Responsible party
- Principal investigator, Mark A. Ilgen, University of Michigan
- Investigators
- Allison Lin, M.D., M.S., Principal investigator, University of MichiganMark Ilgen, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433975
- Sponsor's protocol ID
- HUM00166747
- Other IDs
- R33AT010106, R01AT010797
- Acronym
- Persist
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2020
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilgen M, Blow F, Piette JD, Goldstick J, Lewis M, Myers MG, Lin LA. Targeting pain to improve opioid use disorder treatment outcomes: Results of a randomized trial. J Subst Use Addict Treat. 2026 Aug 3:210079. doi: 10.1016/j.josat.2026.210079. Online ahead of print.
PubMed 42546928Ilgen 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 at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04433975
- Acronym / sponsor ID
- Persist / HUM00166747
- Keywords
- Psychosocial Pain Management, Buprenorphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), US Department of Veterans Affairs
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 19 Jan 2025 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 9 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Pain Management (PPMI) | Experimental | Behavioral: Psychosocial Pain Management (PPMI)Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)Two individual telephone educational sessions with research study therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Psychosocial Pain Management (PPMI) |
| 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. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
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.
7 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42546928Ilgen M, Blow F, Piette JD, Goldstick J, Lewis M, Myers MG, Lin LA. Targeting pain to improve opioid use disorder treatment outcomes: Results of a randomized trial. J Subst Use Addict Treat. 2026 Aug 3:210079. doi: 10.1016/j.josat.2026.210079. Online ahead of print.
- Derived from this study: PubMed 40972890Ilgen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Lin, M.D., M.S. principal investigator
University of Michigan
Mark Ilgen, Ph.D. principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Pain Management (PPMI) in people with Opioid-use Disorder and Medication Assisted Treatment, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months (time frame: 3-months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433975, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.