Methadone (50% dose) for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Addiction Treatment Services (ATS), Baltimore, MD
Chronic Pain+3 More
Methadone (50% dose) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.

Eligible Conditions

  • Chronic Pain
  • Methadone
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Weeks 1, 6, and 12

Week 1
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
Week 12
Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale
Week 1
Change in Pain Tolerance Latency

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Treatment as Usual (TAU)
1 of 2
Split-dosing
1 of 2
Active Control
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Methadone (50% dose) · No Placebo Group · Phase 2

Split-dosing
Drug
Experimental Group · 1 Intervention: Methadone (50% dose) · Intervention Types: Drug
Treatment as Usual (TAU)
Drug
ActiveComparator Group · 1 Intervention: Methadone (100% dose) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 1, 6, and 12
Closest Location: Addiction Treatment Services (ATS) · Baltimore, MD
Photo of Baltimore 1Photo of Baltimore 2Photo of Baltimore 3
2020First Recorded Clinical Trial
1 TrialsResearching Chronic Pain
1 CompletedClinical Trials

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,033 Previous Clinical Trials
30,782,225 Total Patients Enrolled
10 Trials studying Chronic Pain
1,509 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,203 Previous Clinical Trials
5,610,329 Total Patients Enrolled
44 Trials studying Chronic Pain
61,492 Patients Enrolled for Chronic Pain
Kelly E Dunn, PhD, M.B.A.Principal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have to be aged 18 years or older.
You are currently receiving methadone for treatment of OUD and have been consuming the same dose for >30 days.
You have previously received a take-home dose of methadone as part of routine care.
You must be willing to carry a cellular phone provided by the study during one phase of the study.
You are willing to comply with the study schedule.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.