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Opioid Treatment

Usual Care + Patient-Oriented Dosing (POD) for Chronic Pain (TREETOP Trial)

Phase 4

Waitlist Available

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

TREETOP 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.Check my eligibility

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.See study design

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.

TREETOP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

TREETOP 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,472 Previous Clinical Trials

2,619,162 Total Patients Enrolled

55 Trials studying Chronic Pain

82,500 Patients Enrolled for Chronic Pain

Jessica MerlinLead Sponsor

Jessica S Merlin, MD, PhD, MBAPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted approval for Patient-Oriented Dosing (POD) in combination with standard care?

"According to our assessment at Power, the safety rating for Usual Care + Patient-Oriented Dosing (POD) is graded as 3 on a scale of 1 to 3. This favorable score stems from its Phase 4 trial status, indicating regulatory approval."

Answered by AI

At how many different venues is this clinical trial currently accessible?

"At present, this clinical study is conducted at 13 diverse locations, including Portland, New Kensington, and Hagerstown. It's advisable to choose a site in close proximity to reduce travel obligations for potential participants."

Answered by AI

Is this medical study actively seeking participants at the moment?

"Per information from clinicaltrials.gov, this particular research endeavor is presently not seeking participants. Originally listed on May 1st, 2024 and last revised on April 11th, 2024. However, there are currently a total of 684 other trials actively enrolling patients at the moment."

Answered by AI

Could you please outline the main goals of this medical study?

"The primary goal of this research, to be evaluated approximately at baseline and 3 months, is the retention rate of individuals undergoing buprenorphine treatment at the 3-month mark post-baseline. Secondary objectives encompass alterations in Pain Catastrophizing as measured by the Pain Catastrophizing Questionnaire-6-item after a span of 3 months from baseline. This questionnaire comprises six self-reported items assessing pain catastrophizing for chronic pain on a scale ranging from 0 (not at all) to 4 (all the time), summing up to scores between 0 and 24 denoting increasing levels of catastrophic thinking"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jessica Merlin 2024. "Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06367387.

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