Ketones for Opioid Craving

ConditionOpioid Use Disorder

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorUniversity of Maryland, Baltimore

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Treatment with Ketone Supplement
Treatment with Placebo

Treatment groups

50 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Maryland, Baltimore

Lead sponsor

Caron Treatment Centers

Collaborator

Source ClinicalTrials.gov