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Opioid Use DisorderPhase 4TREETOPNCT06367387

Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment

A Phase 4 study testing Patient-Oriented Dosing (POD), Pain Self-Management (PSM) and Standard Buprenorphine Dosing Condition in people with Opioid Use Disorder and Chronic Pain, run by Erin Winstanley at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv). The research study is testing two different interventions along with usual clinical care: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use Disorder, Chronic Pain
What is being tested?
Patient-Oriented Dosing (POD), Pain Self-Management (PSM) and Standard Buprenorphine Dosing Condition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
13 sitesUnited States
Study dates
28 May 2024to 9 Oct 2026
Phase
Phase 4
Are there results?
None posted in the registry

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

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Adults at least 18 years old
  • Patient at a participating clinic
  • Ability to speak, read, and understand English
  • Capable of providing informed consent
  • Access to phone and/or internet
Show all 9Show fewer
  • Documented diagnosis of Opioid Use Disorder (OUD)
  • On a stable dose of an oral or sublingual buprenorphine mono or combination product (<4 times per day, daily dosage <32 mg) for at least 7 days during incident new episode of care
  • Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Under 18 years of age
  • Have cancer-related pain
  • Are currently in jail, prison, or overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
  • Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
  • Currently prescribed an injectable formulation of buprenorphine
Show all 12Show fewer
  • Pregnancy or intention to become pregnant within 4 months of enrollment
  • Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days
  • History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock
  • Currently prescribed/taking methadone or have taken methadone in the past 30 days
  • Had an intentional suicide attempt within the past 3 months
  • Individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders will not be excluded.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center

    Baltimore, Maryland, 21223

  • MATClinics

    Dundalk, Maryland, 21222

  • Wells House

    Hagerstown, Maryland, 21740

  • WVU Crisis Support & Recovery Center

    Martinsburg, West Virginia, 25401

  • UPMC Latterman Family Health Center

    McKeesport, Pennsylvania, 15132

  • WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)

    Morgantown, West Virginia, 26505

  • UPMC St. Margaret Family Health Center

    New Kensington, Pennsylvania, 15068

  • UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC)

    Pittsburgh, Pennsylvania, 15213

  • UPMC Internal Medicine Recovery Engagement Program (IM-REP)

    Pittsburgh, Pennsylvania, 15219

  • Central City Concern (CCC)

    Portland, Oregon, 97209

  • Recovery Works Northwest (RWNW)

    Portland, Oregon, 97233

  • OHSU Harm Reduction Bridges to Care (HRBR)

    Portland, Oregon, 97239

  • OHSU Internal Medicine Clinic (IMC)

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial

This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv).

The research study is testing two different interventions along with usual clinical care:

Read more
  1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain.
  2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.

The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation.

There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention.

Being tested
Patient-Oriented Dosing (POD), Pain Self-Management (PSM), Usual Care, Standard Buprenorphine Dosing Condition
Keywords
pain self-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.

  • Patient-Oriented Dosing (POD)Drug

    Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone to treat individuals with both OUD and chronic pain. It is based on existing evidence related to buprenorphine for the treatment of pain. POD allows participants to receive a daily dosage of bup up to 32mg/day, split up to 4 times per day.

    A response-guided dosing strategy, in which buprenorphine or buprenorphine/naloxone doses will be titrated based on a participant response, will be used to identify a dose regimen that is safe and effective. Due to inter-individual pharmacokinetic/pharmacodynamic variability, POD dosing will be individualized based on a participant's pain intensity and interference.

  • Pain Self-Management (PSM)Behavioural

    Pain self-management (PSM) is a manualized behavioral intervention consisting of 12 sessions, comprising 6 group and 6 individual sessions. The first session will be individual, followed by a group session, and then alternating weekly for the remainder of the intervention.

    Individual sessions will be led by a staff Interventionist trained in the pain self-management intervention. The interventionist will guide participants through a PSM study manual, providing education, teaching associated skills, and assisting with goal setting.

    Group sessions will be led by a Peer Facilitator who has experience with chronic pain, opioid use disorder, and buprenorphine treatment. These sessions will not have specific content but will serve as supportive forums for participants to discuss their experiences with the intervention, share tips for managing chronic pain, and provide mutual support.

  • Usual CareBehavioural

    Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions.

  • Standard Buprenorphine Dosing ConditionDrug

    Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.

Study groups in NCT06367387
Study groupRoleWhat they receive
Usual Care + Standard Buprenorphine DosingActive comparatorUsual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions. Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Receives: Behavioral: Usual Care; Drug: Standard Buprenorphine Dosing Condition
Usual Care + Patient-Oriented Dosing (POD)ExperimentalUsual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions. Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
Receives: Drug: Patient-Oriented Dosing (POD); Behavioral: Usual Care
Pain Self-Management (PSM) + Standard Buprenorphine DosingExperimentalPain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions. Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Receives: Behavioral: Pain Self-Management (PSM); Drug: Standard Buprenorphine Dosing Condition
Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)ExperimentalPain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions. Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
Receives: Drug: Patient-Oriented Dosing (POD); Behavioral: Pain Self-Management (PSM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline

    The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. That is, a person has more problems with pain hindering activities. By comparison, a pain interference T-score of 40 is one SD better than average.

    Change = 3 month score - baseline score

    Measured: Baseline, 3 Months

Secondary outcomes (7)

  1. Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline

    The Pain, Enjoyment, and General Activity (PEG) Scale is a validated, self-report 3-item tool assessing pain intensity and interference over the past week. The PEG scale consists of 3 separate numerical scales. Each scale has ratings ranging from 0-10. The PEG score is calculated by averaging the three numbers; a higher score indicates greater pain.

    Change = 3 month score - baseline score

    Measured: Baseline, 3 Months

  2. Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline

    The Pain Catastrophizing Scale is a validated, self-report 6-item tool assessing assess pain catastrophizing for chronic pain. The PCS-6 uses a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 24, with higher score representing greater catastrophic thinking.

    Change = 3 month score - baseline score

    Measured: Baseline, 3 Months

  3. Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline

    Proportion retained is defined as # completed visits divided by # scheduled visits

    Measured: 3 Months

  4. Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline

    Measured by self-report and medical chart extraction

    Measured: 3 Months, 6 Months, 9 Months, 12 Months

  5. Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline

    The PROMIS Self-Efficacy for Managing Symptoms - Short Form 4a is a validated, self-report 4-item tool assessing current level of confidence to managing symptoms in relation to a chronic condition. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (I am not confident at all) to 5 ( I am very confident). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Emotions indicates that the respondent has greater self-efficacy for managing their emotions than the general chronic condition population (i.e., half a standard deviation higher).

    Change = 3 month score - baseline score

    Measured: Baseline, 3 Months

  6. Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline

    The modified ASI is a validated, self-report tool which includes questions from the Addiction Severity Index section on drug and alcohol use and includes questions about specific opioids used. The number of days in the last 30 that a participant reports using heroin, fentanyl, and/or opioid analgesics (percocet, oxycodone, oxycontin, vicodin, dilaudid, hydrocodone, hydromorphone, morphine, or codeine) will be summed for the outcome "Number of days non-prescribed opioids were used in the past 30 days." Number of days may range from 0 to 90.

    Measured: 3 Months

  7. Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline

    The IMPOWR Opioid Misuse Screening scale is an exploratory, self-report scale consisting of 4 questions about the use of prescribed pain medications. Each question response ranges from Never (0) to Almost Always (4) with a possible summed score ranging from 0 to 16, with higher scores indicating more severe misuse.

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start28 May 2024
  3. Primary completion9 Feb 2026
  4. Study completion9 Oct 2026

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Participants will be stratified by recruitment clinic and dose of buprenorphine at enrollment (≤16 mg vs \>16 mg) and randomized in 2x2 factorial design: 1) either to PSM or Usual Care, and then 2) either to POD or standard buprenorphine dosing. The randomization schema will be generated by the TREETOP Data Core using a stratified permuted block design and will be integrated into the web-based data collection and management system (REDCap).
Masking
None (open label)
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06367387
Sponsor's protocol ID
STUDY23080191
Other IDs
RM1DA055311
Acronym
TREETOP
Status last verified
Nov 2026
First submitted
3 Apr 2024
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: This study will comply with the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy) and data for this study will be available to the public through the IMPOWR Dissemination Education and Coordination Center (IDEA-CC) (https://heal.nih.gov/research/clinical-research/integrative-management-chronic-pain).

Publications

  • Salay M, Edwards KA, Winstanley EL, Bachrach RL, Bulls HW, Hanmer J, Liebschutz JM, Robbins J, Wilson JD, Yu L, Merlin JS, Murray-Krezan C. Study Protocol for Pain Self-Management and Patient-Oriented Buprenorphine Dosing for Pain and Retention in Office-Based Opioid Treatment: A Hybrid Type 1, 2 x 2 Factorial Randomized Controlled Trial. Subst Use Addctn J. 2025 Jan;46(1):201-207. doi: 10.1177/29767342241261562. Epub 2024 Jun 22.

    PubMed 38907678

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Patient-Oriented Dosing (POD), Pain Self-Management (PSM) and Standard Buprenorphine Dosing Condition in people with Opioid Use Disorder and Chronic Pain, run by Erin Winstanley at 13 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 9 inclusion and 12 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline (time frame: Baseline, 3 Months). 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 NCT06367387, which also lists 1 linked publication.

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 5 Nov 2026.

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