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Telemedicine-Based Pain Management for Opioid Use Disorder

N/A

Recruiting

Led By William Becker, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Participants not engaged in TCM intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks and 10 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two different methods for managing pain and opioid use disorder (OUD), to see which is more effective. The first method is telemedicine and collaborative management (TCM), and the second is TCM plus Cooperative Pain Education and Self-Management (COPES). The trial will compare the two methods to see which one leads to better outcomes for patients.

Who is the study for?

Pain CHAMP is for individuals with opioid use disorder or opioid abuse who are engaged in telemedicine and collaborative management (TCM) at a participating study site. Providers involved with these sites can also participate. Those not engaged in TCM or connected to a study site cannot join.

What is being tested?

The trial compares two approaches: one group receives standard TCM, while the other gets TCM plus an additional program called Cooperative Pain Education and Self-Management (COPES). The goal is to see which method better reduces pain interference and symptoms of opioid misuse.

What are the potential side effects?

Since this trial focuses on non-pharmacological interventions like education and self-management programs, traditional medication side effects are not a primary concern; however, participants may experience varying levels of discomfort or stress during the process.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently participating in any traditional Chinese medicine treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks and 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks and 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks and 10 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

Proportion of participants achieving improvement in pain interference with OUD resolution

Proportion of participants on a TCM panel that achieve BUP stabilization

Proportion of participants that initiate COPES

Secondary study objectives

Maintenance of medication management for ≥1 patients post-implementation

Maintenance of referral to COPES post-implementation

Alcohol Use Disorder

+7 more

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: TCM plus COPESExperimental Treatment1 Intervention

Participants in this arm will use TCM plus COPES that will augment the effectiveness of TCM alone.

Group II: TCMActive Control1 Intervention

TCM uses clinical pharmacists leading LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. Clinical pharmacists will lead LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician.

0 / 1Eligibility criteria met