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NCT07128524 · ClinicalTrials.gov registry record · Phase 2

Ketones for Opioid Craving

A Phase 2 study, sponsored by University of Maryland, Baltimore.

Not yet
Registry status
Phase 2
Development phase
50
Enrollment target

NCT07128524: Clinical Trial Phase 2 study, sponsored by University of Maryland, Baltimore.

NCT07128524 is a Phase 2 study that has not yet begun recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07128524, a Phase 2 study, has not yet begun recruiting, sponsored by University of Maryland, Baltimore.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target

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

Primary Outcome

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 sco

Interventions

  • DIETARY_SUPPLEMENT Treatment with Ketone Supplement
  • DIETARY_SUPPLEMENT Treatment with Placebo

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2026-07
Est. Completion 2027-09
Phase Phase 2
University of Maryland, Baltimore

560 total trials

What is known before NCT07128524 opens enrollment

NCT07128524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Treatment with Ketone Supplement is the first listed.

NCT07128524 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07128524 about?

NCT07128524 is a clinical study titled "Ketones for Opioid Craving". 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...

What is the current status of trial NCT07128524?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-07. Estimated completion is 2027-09.

What interventions are being tested in trial NCT07128524?

The interventions under investigation include: Treatment with Ketone Supplement (DIETARY_SUPPLEMENT), Treatment with Placebo (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT07128524?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07128524's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07128524, the US trial registry maintained by the National Library of Medicine. NCT07128524 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.