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Divided or Single Exposure (DOSE) Study

NCT05459402 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-03

No results posted yet for this 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.

Conditions

Interventions

DRUG

Methadone (100% dose)

Methadone for the treatment of opioid use disorder

DRUG

Methadone (50% dose)

Methadone for the treatment of opioid use disorder

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Kelly E Dunn, PhD, M.B.A. · University of Maryland

  • Denis Antoine, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2027-06-01
Completion
2028-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05459402 on ClinicalTrials.gov