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Opioid Agonist

Methadone Dosing for Opioid Use Disorder

Phase 2
Recruiting
Led By Kelly E Dunn, PhD, M.B.A.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years of age or older
Currently receiving methadone for treatment of OUD for >90 days and have been consuming the same dose for >30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 6, and 12
Awards & highlights

Study Summary

This trial will compare the effectiveness of two different methadone dosing schedules for people with both pain and an opioid use disorder.

Who is the study for?
This trial is for adults over 18 who have been on a stable methadone dose for opioid use disorder (OUD) treatment for at least 90 days. Participants must be willing to follow the study schedule, carry a phone during part of the study, and experience chronic pain. Pregnant individuals or those with acute medical issues, severe mental illness, or conditions that contraindicate split-dosing of methadone are excluded.Check my eligibility
What is being tested?
The study is testing if taking methadone once daily versus twice daily can effectively manage both chronic pain and OUD. Participants will receive either their full dose all at once or half the dose twice a day to see which method works better.See study design
What are the potential side effects?
Methadone may cause side effects such as drowsiness, dizziness, constipation, nausea, vomiting, sweating and changes in mood. The risk of side effects might vary depending on whether it's taken once or twice daily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been on a stable dose of methadone for OUD for over 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 6, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 6, and 12 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 worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale
Secondary outcome measures
Change in Opioid Withdrawal Severity- past 24 hours as assessed by the Subjective Opioid Withdrawal Scale
Change in Pain Interference- past 7 days as assessed by Pain-related Disability Scale Total Score
Change in Pain Tolerance Latency

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Split-dosingExperimental Treatment1 Intervention
Participants in split dosing group will receive 50% active methadone + placebo twice daily.
Group II: Treatment as Usual (TAU)Active Control1 Intervention
Participants in treatment as usual group will receive 100% active methadone in AM + placebo in PM.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,259 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,015 Total Patients Enrolled
Kelly E Dunn, PhD, M.B.A.Principal InvestigatorJohns Hopkins University

Media Library

Methadone (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05459402 — Phase 2
Opioid Use Disorder Research Study Groups: Treatment as Usual (TAU), Split-dosing
Opioid Use Disorder Clinical Trial 2023: Methadone Highlights & Side Effects. Trial Name: NCT05459402 — Phase 2
Methadone (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05459402 — Phase 2

Frequently Asked Questions

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

Does a 50% dose of Methadone carry the same risks as a full dose?

"While there is some evidence that Methadone (50% dose) is safe, efficacy has not been proven. Consequently, it received a score of 2."

Answered by AI

Are there any open positions for research subjects?

"Unfortunately, this study is not enrolling patients at the moment. The trial was first posted on 11/1/2022 and was last updated on 8/24/2022. Although 692 other clinical trials are recruiting right now."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Addiction Treatment Services (ATS)
How many prior treatments have patients received?
3+

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Divided or Single Exposure (DOSE) Study
2023. "Divided or Single Exposure (DOSE) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05459402.
~100 spots leftby Oct 2028
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