Ketones for Opioid Craving

NCT07128524 | Not Yet Recruiting Phase 2

• 1 other identifier: HP-00114810
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tonic Craving (FORCAST) total scores

  Faceted Opioid Research Craving Assessment for Substance use Treatment (FORCAST) (Opioid Craving): A 26-item assessment of tonic craving that the person reports having felt over the prior one or two weeks. Participants indicate how much they disagree or agree with each statement on a scale that ranges from 0-6, with 0 representing "strongly disagree", 3 representing "neither agree nor disagree", and 6 representing "strongly agree". Higher scores indicate higher levels of craving. The minimum score is 0, and the maximum scores for each of the subscales are as follows: Preoccupation: 24 Negative Reinforcement: 30 Positive Reinforcement: 24 Motivation: 30 Lack of control: 24 Uneasiness: 24 Maximum total score for all subscales = 156

  Collected at baseline, and day 7

Secondary Outcomes (6)

• Subjective Opioid Withdrawal

  Collected at baseline and days 1-7

• Pain Sensitivity (Cold Pressor Test)

  collected on day 1 and day 7

• Desire for Drugs Questionnaire (DDQ)

  collected on days 1-7

• Mood Ratings on a Visual Analogue Scale (VAS)

  collected on days 1-7

• Chronic pain

  collected at baseline and day 7

Other Outcomes (1)

• Gut microbiome beta diversity

  collected at baseline and day 7

Study Arms (2)

Treatment with Ketone Supplement

EXPERIMENTAL

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

Dietary Supplement: Treatment with Ketone Supplement

Treatment with Placebo

EXPERIMENTAL

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

Dietary Supplement: Treatment with Placebo

Interventions

Treatment with Ketone Supplement DIETARY_SUPPLEMENT

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

Treatment with Ketone Supplement

Treatment with Placebo DIETARY_SUPPLEMENT

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

Treatment with Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Caron Treatment Centers: collaborator

Study Sites (1)

Caron Pennsylvania Addiction Treatment and Rehab Center

Wernersville, Pennsylvania, 19565, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Ketosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Peter Manza, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Manza, PhD

CONTACT

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

Kynah Walston, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2025-10

Locations

US (1)