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Ketamine for Opioid Use Disorder

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 54 words
    • Secondary endpoints revised (9)
    v9
  2. Start date changed from estimate of Feb 2026 to Feb 4, 2026v8
  3. Start date: Jan 2026 to Feb 2026v7
  4. Start date: Dec 2025 to Jan 2026v6
  5. Start date: Nov 2025 to Dec 2025v5
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  1. Start date: Nov 7, 2025 to Nov 2025
    • Interventions: Treatment with Active Placebo (Drug), Treatment with Ketamine (Drug) to Treatment with Ketamine (Drug), Treatment with Very Low Dose Ketamine (Drug)
    • Eligibility criteria expanded, about 70 words
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 1, 2025 to Nov 7, 2025
    • Site details revised
    v3
  3. Start date: Aug 1, 2025 to Nov 1, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults enrolled in methadone treatment for opioid use disorder. The main questions it aims to answer are: * Does ketamine reduce craving for opioids in patients with opioid use disorder? * Does ketamine reduce symptoms of opioid withdrawal such as depression, pain, and poor sleep quality? * Do patients who take the low dose ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the very low dose? Researchers will compare two low doses of ketamine to see if ketamine works to reduce craving for opioids in adults enrolled in methadone treatment for opioid use disorder. Participants will: * Be given a low dose or a very low dose of ketamine 4 times over a period of 2 weeks * Visit with the study team one week prior to the first ketamine session, one week following the last ketamine session, at 30 days following the final ketamine session, and 90 days following the final ketamine session for checkups and tests
Trial Details
NCT Number NCT06943859
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)		 Opioid Use Disorder
Related terms Opioid-Related Disorders, Treatment Adherence and Compliance
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov