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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks and 10 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Change in the number of participants that initiate COPES

Number of participants achieving improvement in pain interference

Number of participants on a TCM panel that achieve BUP stabilization

Secondary outcome measures

Change in the number of participants on a TCM panel experiencing resolution of TAPS-2 Assessment positivity score

Maintenance of medication management for ≥1 patients post-implementation

Maintenance of referral to COPES post-implementation

+8 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,618,230 Total Patients Enrolled

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,736,941 Total Patients Enrolled

William Becker, MDPrincipal InvestigatorYale University

Media Library

TCM Clinical Trial Eligibility Overview. Trial Name: NCT05333341 — N/A

Opioid Use Disorder Research Study Groups: TCM, TCM plus COPES

Opioid Use Disorder Clinical Trial 2023: TCM Highlights & Side Effects. Trial Name: NCT05333341 — N/A

TCM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333341 — N/A

Frequently Asked Questions

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

At how many distinct facilities is this research taking place?

"Ann Arbor VAMC, VA Connecticut HCS and Little Rock VAMC are just some of the sites offering this trial. Additionally, there are 4 other medical centres involved in conducting this research."

Answered by AI

What is the aim of this study?

"This medical trial will last 12 months, with the primary outcome being the number of participants on a TCM panel that attain BUP stabilization. The secondary outcomes include mean changes in sleep (assessed using Brief Pain Inventory - Sleep Item) and anxiety (using Generalized Anxiety Disorder-2 questionnaire), as well as patient encounters where at least one Traditional Chinese Medicine component was implemented by providers over the intervention period."

Answered by AI

Are there any remaining slots for participants in this clinical investigation?

"As of now, the clinical trial listed on clinicaltrials.gov is not presently seeking any additional participants. Originally posted in December 1st 2022 and last updated in September 13th 2022, this study has already filled its requisite quota. However, there are currently 291 other studies actively enrolling patients across the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pain Care at Home to Amplify Function (Pain CHAMP)

2023. "Pain Care at Home to Amplify Function (Pain CHAMP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05333341.