Semaglutide for Helping Opioid Recovery

Study acronym: SHORE
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Sep 1, 2027
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Record History

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  1. Primary completion pushed from Aug 31, 2026 to Sep 1, 2027 Show 5 more changesShow less
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Study completion pushed from Aug 31, 2026 to Sep 15, 2027
    • Eligibility criteria shortened, about 29 words
    • Secondary endpoints: details revised at 13 of 19 entries
    • Site details revised
  2. Primary and study completion dates: Mar 2027 to Aug 31, 2026
    • Start date changed from estimate of Jun 2025 to Jun 2, 2025
    v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2025 to Jun 2025
    • Secondary endpoints: details revised at 1 of 19 entries
    • Site details revised
    v6
  4. Secondary endpoints: details revised at 1 of 19 entriesv5
  5. Eligibility criteria expanded, about 25 words
    • Study description expanded, about 7 words
    v4
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  1. Primary completion date: Feb 1, 2027 to Mar 2027v3 Show 7 more changesShow less
    • Study completion date: Apr 1, 2027 to Mar 2027
    • Start date: Feb 1, 2025 to Mar 2025
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 18 to 19
    • Study description shortened, about 23 words
    • Site contact updated
    • Study title shortened, about 3 words
  2. Secondary endpoints: details revised at 1 of 18 entriesv2
  1. Study First Submitted
  • 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.
The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD.
Trial Details
NCT Number NCT06639464
Lead Sponsor Brigham and Women's Hospital
Conditions
(from sponsor)		 Opioid Use Disorder
Related terms Opioid-Related Disorders
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov