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

Erin Winstanley

Status and phase: Active, not recruiting; Phase 4

Conditions: Opioid Use Disorder; Chronic Pain

Treatments: Behavioral: Usual Care; Drug: Standard Buprenorphine Dosing Condition; Behavioral: Pain Self-Management (PSM); Drug: Patient-Oriented Dosing (POD)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06367387

STUDY23080191

RM1DA055311 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adults at least 18 years old
2. Patient at a participating clinic
3. Ability to speak, read, and understand English
4. Capable of providing informed consent
5. Access to phone and/or internet
6. Documented diagnosis of Opioid Use Disorder (OUD)
7. 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
8. 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:

1. Under 18 years of age
2. Have cancer-related pain
3. 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
4. Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
5. Currently prescribed an injectable formulation of buprenorphine
6. Pregnancy or intention to become pregnant within 4 months of enrollment
7. Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days
8. History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock
9. Currently prescribed/taking methadone or have taken methadone in the past 30 days
10. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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268 participants in 4 patient groups

Usual Care + Standard Buprenorphine Dosing

Active Comparator group

Description:

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

Treatment:

Drug: Standard Buprenorphine Dosing Condition

Behavioral: Usual Care

Usual Care + Patient-Oriented Dosing (POD)

Experimental group

Description:

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. 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.

Treatment:

Drug: Patient-Oriented Dosing (POD)

Behavioral: Usual Care

Pain Self-Management (PSM) + Standard Buprenorphine Dosing

Experimental group

Description:

Pain 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.

Treatment:

Behavioral: Pain Self-Management (PSM)

Drug: Standard Buprenorphine Dosing Condition

Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)

Experimental group

Description:

Pain 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.

Treatment:

Drug: Patient-Oriented Dosing (POD)

Behavioral: Pain Self-Management (PSM)