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TOPPS for Chronic Pain in Opioid Use Disorder (TOPPS Trial)

N/A

Waitlist Available

Led By Michael D Stein, MD

Research Sponsored by Boston University

Eligibility Criteria Checklist

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

Must have

Score of at least 1 on PHQ-2 during prescreen or score of greater than or equal to 8 on PHQ-9 during in person screening

Pain severity of 4 or higher on a numerical rating scale (0-10) indicating 'worst pain in the last week'

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 9

Awards & highlights

TOPPS Trial Summary

This trial is comparing the TOPPS intervention to a health education contact control condition to see if it is effective in decreasing the need to turn to substance misuse to avoid pain.

Who is the study for?

This trial is for adults aged 18-65 with opioid use disorder and chronic pain, who have been on buprenorphine treatment for at least a month. Participants should experience significant pain interference and may also have depression. They must not be planning major changes like moving or surgery within the next year, nor have certain psychiatric conditions or recent heavy drug use.Check my eligibility

What is being tested?

The study compares TOPPS—a program addressing pain, depression, and substance misuse through education and behavioral activation—with standard health education in primary care settings. The goal is to reduce reliance on substances for managing pain over a period of 12 months.See study design

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, side effects are minimal compared to drug trials. However, discussing painful topics might temporarily increase emotional distress.

TOPPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have shown signs of depression based on a screening test.

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My worst pain in the last week was 4 or more on a scale of 0 to 10.

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I will continue taking buprenorphine without reducing the dose for the next year.

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I am between 18 and 65 years old.

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I have been prescribed buprenorphine by my current doctor for at least a month.

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I have had chronic pain for at least three months with moderate to severe impact on my daily life.

TOPPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 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 in Depression based on the PHQ-9

Change in Pain Interference based on the BPI-I

Change in Pain Severity based on the VAS

Secondary outcome measures

Rates of buprenorphine treatment retention

TOPPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treating Opioid Patients' Pain and Sadness (TOPPS)Experimental Treatment1 Intervention

TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.

Group II: Health Education (HE)Active Control1 Intervention

After an initial, brief, joint, in-person meeting with the BHS and primary care physician (PCP), patients have a session that discusses nutrition. For the next 5 telephone sessions, they choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treating Opioid Patients' Pain and Sadness (TOPPS)

2012

N/A

~30

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor

457 Previous Clinical Trials

9,941,695 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,472 Previous Clinical Trials

2,619,459 Total Patients Enrolled

Michael D Stein, MDPrincipal InvestigatorBoston University

5 Previous Clinical Trials

1,240 Total Patients Enrolled

Media Library

Treating Opioid Patients' Pain and Sadness (TOPPS) Clinical Trial Eligibility Overview. Trial Name: NCT03698669 — N/A

Opioid Use Disorder Research Study Groups: Treating Opioid Patients' Pain and Sadness (TOPPS), Health Education (HE)

Opioid Use Disorder Clinical Trial 2023: Treating Opioid Patients' Pain and Sadness (TOPPS) Highlights & Side Effects. Trial Name: NCT03698669 — N/A

Treating Opioid Patients' Pain and Sadness (TOPPS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03698669 — N/A

Frequently Asked Questions

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

Does this research involve participants above the age of forty?

"This trial is seeking individuals who have attained the age of consent and are yet to reach retirement."

Answered by AI

Does my profile meet the criteria to join this research endeavor?

"In order to be considered part of this medical trial, applicants should have a history of opioid addiction and must range between the ages 18 to 65. Ultimately, 250 individuals will take part in the study."

Answered by AI

Are there any current opportunities to enroll in this research trial?

"According to information housed on clinicaltrials.gov, this medical study is actively seeking participants since it was first posted August 21st 2019 and most recently updated August 31st 2022."

Answered by AI

What is the patient sample size of this trial?

"Affirmative. As per the details available on clinicaltrials.gov, this medical trial commenced recruitment in August 2019 and has recently been updated. 250 volunteers need to be recruited at two different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

2019. "Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03698669.

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