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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
Must not have
Presence of acute medical problem that requires immediate and intense medical management
Currently receiving split doses of methadone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 6, and 12
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently dealing with a serious health issue that needs urgent medical attention.
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I am currently taking methadone in divided doses.
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My methadone dose cannot be divided.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale
Secondary study objectives
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

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: 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
2,607 Previous Clinical Trials
3,329,665 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,481 Total Patients Enrolled
Kelly E Dunn, PhD, M.B.A.Principal InvestigatorUniversity of Maryland
Denis Antoine, MDPrincipal 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
~100 spots leftby Oct 2028
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