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Naltrexone in AUD Reward Drinkers

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 2026 to Jul 2027 Completion date: Dec 2027 to Jul 2028v8 Show 1 more changeShow less
    • Completion date: Dec 2027 to Jul 2028
  2. Primary completion date: Nov 2025 to Jul 2026 Completion date: Nov 2026 to Dec 2027 · Eligibility criteria expanded, about 38 wordsv7 Show 2 more changesShow less
    • Completion date: Nov 2026 to Dec 2027
    • Eligibility criteria expanded, about 38 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv6
  4. Primary completion date: Nov 2024 to Nov 2025 Completion date: Nov 2025 to Nov 2026 · Site contact updatedv5 Show 2 more changesShow less
    • Completion date: Nov 2025 to Nov 2026
    • Site contact updated
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Feb 2022 to Mar 7, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2022 to Mar 7, 2022
  2. Start date: Nov 2021 to Feb 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a phase IV, two-arm, randomized, double-blind, placebo-controlled study to assess whether individuals identified as primarily reward drinkers are significantly more likely to reduce heavy drinking if they receive XR-NTX than a matching placebo injection. Study subjects will receive monthly injections of long-acting injectable naltrexone 380 mg (4 mL) or matching placebo. All subjects will also receive 4 sessions of Medical Management (MM). Post-treatment follow-up visits will be conducted at 4 weeks after the scheduled completion of treatment.
Trial Details
NCT Number NCT05028062
Lead Sponsor University of Pennsylvania
Collaborators: Alkermes, Inc.
Conditions Alcohol Use Disorder, Alcoholism
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov