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NCT Number: NCT06367387

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

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. 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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)

Exclusion criteria

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
  • 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.

Treatment and study plan

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)

Behavioral

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 Care

Behavioral

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 Condition

Drug

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

Primary outcomes

  1. 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

    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

Secondary outcomes

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

    Time frame: Baseline, 3 Months

    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

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

    Time frame: Baseline, 3 Months

    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

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

    Time frame: 3 Months

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

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

    Time frame: 3 Months, 6 Months, 9 Months, 12 Months

    Measured by self-report and medical chart extraction

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

    Time frame: Baseline, 3 Months

    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

  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

    Time frame: 3 Months

    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.

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

    Time frame: 3 Months

    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.

Sponsors and collaborators

Lead sponsor

Erin Winstanley

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: TREETOP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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