Ketones for Opioid Craving
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment with Ketone Supplement, Treatment with Placebo.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ketone Supplementation for Opioid Craving and Withdrawal
Overview
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
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.
Primary outcome measures
- Tonic Craving (FORCAST) total scores [Time frame: Collected at baseline, and day 7]
Secondary outcome measures (6)
- Subjective Opioid Withdrawal [Time frame: Collected at baseline and days 1-7]
- Pain Sensitivity (Cold Pressor Test) [Time frame: collected on day 1 and day 7]
- Desire for Drugs Questionnaire (DDQ) [Time frame: collected on days 1-7]
- Mood Ratings on a Visual Analogue Scale (VAS) [Time frame: collected on days 1-7]
- Chronic pain [Time frame: collected at baseline and day 7]
- Mood (Positive and Negative Affect Schedule) [Time frame: collected days 1-7]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Caron Pennsylvania Addiction Treatment and Rehab Center — Wernersville
Identifiers
NCT: NCT07128524 · HP-00114810