Ketones for Opioid Craving
NCT07128524 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-03-13
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
More Related Trials
-
Oxytocin Treatment of Opioid Dependence
NCT02548728 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
NCT04316559 ·Status: COMPLETED ·Phase: PHASE2
-
Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
NCT01259115 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
NCT01125917 ·Status: TERMINATED ·Phase: PHASE3
-
Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence
NCT00134888 ·Status: COMPLETED ·Phase: NA
-
Effects of Dronabinol in Opioid Maintained Patients
NCT04025359 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Long-acting Naltrexone for Pre-release Prisoners
NCT02867124 ·Status: COMPLETED ·Phase: PHASE3
-
Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9
NCT00000344 ·Status: COMPLETED ·Phase: PHASE2
-
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
NCT02737826 ·Status: COMPLETED ·Phase: NA
-
Low-dose Versus a High-dose Sublingual Buprenorphine Induction
NCT05944952 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail
NCT04408313 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Cannabidiol in the Treatment of Opioid Use Disorder
NCT06206291 ·Status: COMPLETED ·Phase: PHASE2
-
Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
NCT00015028 ·Status: COMPLETED ·Phase: PHASE2
-
Buprenorphine Combination Tablet Feasibility - 1
NCT00000298 ·Status: COMPLETED ·Phase: PHASE2
-
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
NCT00315445 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
NCT01046539 ·Status: COMPLETED ·Phase: PHASE1
-
Depot Naltrexone Treatment of Opioid Dependent Parolees
NCT00756990 ·Status: COMPLETED ·Phase: NA
-
Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
NCT04192370 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence
NCT00134914 ·Status: COMPLETED ·Phase: NA
-
Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance
NCT01642030 ·Status: COMPLETED ·Phase: PHASE1
-
Improving Treatment Outcomes for Prescription Opioid Dependence
NCT02543944 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Buprenorphine as a Treatment in Opiate Dependent Pain Patients
NCT00552578 ·Status: TERMINATED ·Phase: PHASE4
-
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
NCT00315874 ·Status: COMPLETED ·Phase: PHASE3
-
GLP-1R Agonist Treatment for Opioid Use Disorder
NCT06548490 ·Status: RECRUITING ·Phase: PHASE2
-
Clinical Trials of Multivalent Opioid Vaccine Components
NCT04458545 ·Status: RECRUITING ·Phase: PHASE1/PHASE2