Ketones for Opioid Craving

NCT07128524 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Treatment with Ketone Supplement

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

DIETARY_SUPPLEMENT

Treatment with Placebo

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

Sponsors & Collaborators

  • Caron Treatment Centers

    collaborator OTHER
  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Peter Manza, PhD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-08-31
Completion
2027-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128524 on ClinicalTrials.gov