Not Yet RecruitingPhase 2

Ketones for Opioid Craving

United States50 participantsStarted 2026-05

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-75 years * Meets currents DSM-5 criteria for OUD and admitted for opioid withdrawal management treatment at Caron Treatment Center * Willingness to provide signed, informed consent and commit to completing the procedures in the study Exclusion Criteria: * Current severe gastrointestinal (GI), liver, or other clinically significant physical disease that may interfere with the intake of the ketone supplement (e.g., sever inflammatory bowel disease, cirrhosis). * Currently taking (within the past two weeks) GLP-1 receptor agonist medications, e.g. semaglutide, which can interfere with the absorption of the ketone supplement * Currently pregnant or lactating, for people of childbearing potential * Judged by the principal investigator. study physician, or their designee to be an unsuitable candidate for the study

What they're measuring

Tonic Craving (FORCAST) total scores

Timeframe: Collected at baseline, and day 7

Trial details

NCT IDNCT07128524

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Peter Manza, PhD

410-706-2814 peter.manza@som.umaryland.edu