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Opioid Treatment

Pain Management Strategies for Chronic Pain (TREETOP Trial)

Phase 4

Recruiting

Led By Jessica S Merlin, MD, PhD, MBA

Research Sponsored by Jessica Merlin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 9 months, 12 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to improve chronic pain treatment for individuals taking buprenorphine. Participants will receive either Pain Self-Management or Patient-Oriented Dosing in addition to usual care over 12

Who is the study for?

This trial is for individuals with chronic pain who are also taking buprenorphine for opioid use disorder. Participants should be interested in learning to manage their pain or trying a new way of dosing their medication. Specific eligibility criteria were not provided, so it's important to contact the study team for more details.

What is being tested?

The study tests two interventions: Pain Self-Management (PSM), where participants learn from a coach and peer about managing chronic pain, and Patient-Oriented Dosing (POD), which adjusts buprenorphine dosage based on individual pain levels, alongside usual care over 12 weeks.

What are the potential side effects?

Possible side effects include psychological distress from discussing sensitive topics and risks related to adjusting buprenorphine doses. There may also be a risk of confidentiality breaches during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 9 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

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

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Usual Care + Patient-Oriented Dosing (POD)Experimental Treatment2 Interventions

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.

Group II: Pain Self-Management (PSM) + Standard Buprenorphine DosingExperimental Treatment2 Interventions

Group III: Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)Experimental Treatment2 Interventions

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.

Group IV: Usual Care + Standard Buprenorphine DosingActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

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