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NCT07128524PHASE2Recruiting

Ketones for Opioid Craving

University of Maryland, Baltimore

Start Date

7/16/2026

Completion Date

9/1/2027

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

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DIETARY_SUPPLEMENT

Treatment with Ketone Supplement

DIETARY_SUPPLEMENT

Treatment with Placebo

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Conditions

Opioid Use Disorder

Locations

Caron Pennsylvania Addiction Treatment and Rehab Center

Wernersville, Pennsylvania 19565

United States