Ketones for Opioid Craving

Part of paid clinical trials in Wernersville, Pennsylvania.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07128524
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment with Ketone Supplement — DIETARY_SUPPLEMENT
    Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.
  • Treatment with Placebo — DIETARY_SUPPLEMENT
    Participants (n=25) will receive three doses of a placebo drink for seven days.

Study Details

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

Key Dates

First listed
Aug 19, 2025
Start date
Jul 16, 2026
Status verified
Oct 2025
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Treatment with Ketone Supplement
    Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.
  • Experimental: Treatment with Placebo
    Participants (n=25) will receive three doses of a placebo drink daily for seven days.

Primary Outcome Measure

Tonic Craving (FORCAST) total scores [ Time Frame: Collected at baseline, and day 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Caron Pennsylvania Addiction Treatment and Rehab CenterWernersvillePennsylvania19565
Erin Takemoto, PhD
[email protected]
484-345-2626

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By research site
Caron Pennsylvania Addiction Treatment and Rehab Center· Wernersville, PA

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