Divided or Single Exposure (DOSE) Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05459402
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Chronic Pain
  • Methadone
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Methadone (100% dose) — DRUG
    Methadone for the treatment of opioid use disorder
  • Methadone (50% dose) — DRUG
    Methadone for the treatment of opioid use disorder

Study Details

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.

Key Dates

Start date
Feb 21, 2023
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Addiction Treatment Services (ATS)BaltimoreMaryland21224
Denis Antoine, MD

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Addiction Treatment Services (ATS)· Baltimore, MD

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