Last reviewed · How we verify
NCT07128524
Ketone Supplementation for Opioid Craving and Withdrawal
Phase 2 trial testing Treatment with Ketone Supplement in Opioid Use Disorder in 50 participants. Not yet recruiting.
31 August 2027
Quick facts
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 May 2026 |
| Primary completion | 31 August 2027 |
| Estimated completion | 1 September 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Treatment with Ketone Supplement
- Treatment with Placebo — full drug profile →
Conditions studied
- Opioid Use Disorder — all drugs for Opioid Use Disorder →
Sponsor
University of Maryland, Baltimore
Who can join
Adults 18 to 75, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Tonic Craving (FORCAST) total scores
Time frame: Collected at baseline, and day 7
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", a
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07128524
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Opioid Use Disorder
Currently open trials in the same condition.
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- NCT07158853 — Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder · NA · recruiting
- NCT06943859 — Ketamine for Opioid Use Disorder · Phase 2 · recruiting
- NCT06651177 — Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder · Phase 2 · recruiting
Other University of Maryland, Baltimore trials
Trials by the same sponsor.
- NCT07537413 — Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia · Phase 4 · not yet recruiting
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- NCT07094672 — Development of an Opioid Withdrawal Clinical Outcome Assessment · not yet recruiting
- NCT06583239 — Hub-Based Engagement Navigator Service to Reduce CSC Disengagement · NA · not yet recruiting
- NCT07536412 — Decision Aid Efficacy in Low Risk Thyroid Cancer · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07128524 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
- Last refreshed: 11 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07128524.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing