Ketones for Opioid Craving

University of Maryland Baltimore (UMB)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Opioid Use Disorder

Treatments: Dietary Supplement: Treatment with Placebo; Dietary Supplement: Treatment with Ketone Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07128524

HP-00114810

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Treatment with Ketone Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Treatment with Ketone Supplement

Treatment with Placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: Treatment with Placebo