Recruiting
Phase 2
Phase 3

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT05459402

Conditions

Opioid Use Disorder

Chronic Pain

Methadone

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Methadone (100% dose)

Methadone (50% dose)

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Chronic Pain

Methadone

Study ID

NCT05459402

Start date

Feb 21, 2023

Status verified date

Jan, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Have previously received a take-home dose of methadone as part of routine care
  • Willing to comply with study schedule
  • Report pain (specific definition blinded)
  • Have a cellular phone or be willing to carry phone provided by the study during one phase of the study

Exclusion Criteria:

  • Pregnant
  • Presence of acute medical problem that requires immediate and intense medical management
  • Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and/or adherence to study visits
  • Plans to leave methadone treatment during the study period
  • Maintained on a dose of methadone that would prevent effective splitting of doses
  • Currently receiving split doses of methadone
  • Currently receiving treatment for pain for which the split-dosing of methadone is judged by medical staff to be contraindicated or otherwise interfere with study conduct or integrity
  • Does not meet criteria for mild-severe disability (definition blinded)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment as Usual (TAU)

Participants in treatment as usual group will receive 100% active methadone in AM + placebo in PM.

experimental: Split-dosing

Participants in split dosing group will receive 50% active methadone + placebo twice daily.

Interventions

Methadone (100% dose)

Methadone for the treatment of opioid use disorder

Methadone (50% dose)

Methadone for the treatment of opioid use disorder

Primary outcome measure

  • Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale [ Time Frame: Week 1 up to week 12 ]

Central Contacts and Locations

Central contacts

Kelly E Dunn, PhD, M.B.A.

802-922-1682kelly.dunn@som.umaryland.edu

Locations

Addiction Treatment Services (ATS)

Recruiting

Baltimore, Maryland, United States, 21224

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-02-03.