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Computer-Based Cognitive Behavioral Therapy for Chronic Pain in Opioid Treatment (IMPACT Trial)

N/A
Recruiting
Led By Alicia Heapy, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Enrolled in methadone or buprenorphine treatment at Liberation
Eligible participants will be 18 years of age or older
Must not have
Planned surgical treatment related to pain
Life threatening health conditions that would impede participation (e.g., end stage renal failure, malignant cancer requiring chemotherapy excluding melanoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cognitive behavioral therapy program for people with chronic pain who are also being treated with buprenorphine or methadone. The therapy program includes components from an existing program (CBT4CBT) and a new program (COPES). The trial will compare the new program to standard care in a group of 160 people, measuring outcomes such as pain interference and adherence to agonist treatment.

Who is the study for?
Adults over 18 with opioid use disorder (OUD) who are on methadone or buprenorphine treatment and have chronic pain. They must be able to walk a block, speak English at a basic level, and not have severe health issues or untreated mental disorders that could interfere with the study.
What is being tested?
The trial is testing an integrated web-based program combining cognitive-behavioral therapy (CBT4CBT) and Cooperative Pain Education Self-Management (COPES). It aims to improve adherence to medication-assisted treatment for OUD and manage chronic pain better than standard care alone.
What are the potential side effects?
Since this is a behavioral intervention involving education and self-management without medications, there may not be direct side effects like those seen with drugs. However, participants might experience discomfort while learning new coping skills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently in a methadone or buprenorphine program at Liberation.
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I am 18 years old or older.
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I have experienced pain on most days for the last six months.
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I have chronic pain with a severity of 4 or more on a scale of 0-10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for surgery to manage my pain.
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I do not have any severe health conditions that would prevent me from participating.
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I do not have untreated bipolar or psychotic disorders, nor am I at risk of suicide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to opioid agonist treatment (OAT)
Change in PROMIS 6-item Pain Interference Short Form
Secondary study objectives
Drug Use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CBT4CBT-CopesExperimental Treatment1 Intervention
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
Group II: Standard care treatment as usual (TAU)Active Control1 Intervention
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
854 Previous Clinical Trials
671,600 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,098 Total Patients Enrolled
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,031,323 Total Patients Enrolled

Media Library

CBT4CBT COPES Clinical Trial Eligibility Overview. Trial Name: NCT05204576 — N/A
Opioid Use Disorder Research Study Groups: Standard care treatment as usual (TAU), CBT4CBT-Copes
Opioid Use Disorder Clinical Trial 2023: CBT4CBT COPES Highlights & Side Effects. Trial Name: NCT05204576 — N/A
CBT4CBT COPES 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204576 — N/A
~28 spots leftby Jun 2025
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