MethaLoad Dose-Finding Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06877858
Phase
PHASE1
Status
Recruiting
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Conditions

  • Opioid Use Disorder (OUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methadone hydrochloride — DRUG
    Methadone loading dose initiation (vs. standard initiation in the TAU arm)

Study Details

The goal of this study is to develop a loading dose approach to starting methadone to treat opioid use disorder with fentanyl use ("fentanyl OUD", herein). This study is a participant- and assessor- blinded dose-finding study using the Bayesian optimal interval (BOIN) design. Investigators aim to recruit n=24 participants with fentanyl OUD to a research unit for monitored methadone initiation. Participants will be randomized to standard initiation vs. loading dose initiation at one of four doses.

Key Dates

Start date
Sep 25, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Active Comparator: Treatment as usual (TAU)
    Day 1: 40mg oral methadone Day 2: 40mg oral methadone
  • Experimental: Loading Dose
    Day 1: loading dose (60mg, 80mg, 100mg, or 120mg oral methadone) Day 2: 50% of the loading dose (30mg, 40mg, 50, or 60mg oral methadone)

Primary Outcome Measure

Dose-limiting toxicity (DLT) rate [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Center for Studies of Addiction (CSA)PhiladelphiaPennsylvania19104
Megan Ivey
[email protected]
215-746-0222
Ashish P Thakrar, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Penn Center for Studies of Addiction (CSA)· Philadelphia, PA

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