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Ketones for Opioid Craving

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Jul 2026 to Jul 16, 2026
    • Site details revised
    v10
  2. Minor Start date: Jun 2026 to Jul 2026v9
  3. Minor Start date: May 2026 to Jun 2026v8
  4. Notable Start date: Mar 2026 to May 2026v7
  5. Minor Start date: Jan 2026 to Mar 2026v6
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  1. Notable Start date: Dec 1, 2025 to Jan 2026v5
  2. Notable Start date: Nov 1, 2025 to Dec 1, 2025v4
  3. Notable Start date: Sep 1, 2025 to Nov 1, 2025v3
  4. Minor Secondary endpoints revised (6)v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn if ketone supplementation (KS) works to reduce craving for opioids for adults with opioid use disorder (OUD) undergoing in-patient acute withdrawal management. The main questions it aims to answer are: * Does KS reduce craving for opioids in patients with opioid use disorder? * Does KS reduce symptoms of opioid withdrawal such as low mood and pain? Researchers will compare KS to a placebo to see if KS works to reduce craving for opioids and reduce withdrawal symptoms in adults entering in-patient acute withdrawal management for opioid use disorder. Participants will: * Be given KS or a placebo three (3) times daily for seven (7) days * Complete mood, pain tolerance, and subjective opioid withdrawal assessments
Trial Details
NCT Number NCT07128524
Lead Sponsor University of Maryland, Baltimore
Collaborators: Caron Treatment Centers
Conditions
(from sponsor)
Opioid Use Disorder
Related terms Ketosis, Opioid-Related Disorders
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov