Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2026-03-31
2027-09-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment with Ketone Supplement
Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.
Treatment with Ketone Supplement
Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.
Treatment with Placebo
Participants (n=25) will receive three doses of a placebo drink daily for seven days.
Treatment with Placebo
Participants (n=25) will receive three doses of a placebo drink for seven days.
Interventions
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Treatment with Ketone Supplement
Participants (n=25) will receive three doses of a ketone supplement drink daily for seven days.
Treatment with Placebo
Participants (n=25) will receive three doses of a placebo drink for seven days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Caron Treatment Centers
OTHER
University of Maryland, Baltimore
OTHER
Responsible Party
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Peter Manza
Assistant Professor
Principal Investigators
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Peter Manza, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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Caron Pennsylvania Addiction Treatment and Rehab Center
Wernersville, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HP-00114810
Identifier Type: -
Identifier Source: org_study_id
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