Recruiting
Phase 2

Ketone Supplementation

Sponsor:

University of Maryland, Baltimore

Code:

NCT07128524

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Treatment with Ketone Supplement

Treatment with Placebo

Study Details

Brief 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

Conditions

Opioid Use Disorder

Study ID

NCT07128524

Start date

Jul 16, 2026

Status verified date

Oct, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Treatment with Ketone Supplement

Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.

Treatment with Placebo

Participants (n=25) will receive three doses of a placebo drink for seven days.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Peter Manza, PhD

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

Kynah Walston, MA

443-974-7951Kynah.Walston@som.umaryland.edu

Locations

Caron Pennsylvania Addiction Treatment and Rehab Center

Recruiting

Wernersville, Pennsylvania, United States, 19565

Contacts

Erin Takemoto, PhD

484-345-2626etakemoto@caron.org

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 25, 2026

Last verified

Oct, 2025

Keywords

  • opioid use disorder
  • OUD
  • ketone
  • ketone supplement
  • ketone supplementation
  • craving
  • withdrawal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-08-25.