Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder

Обзор

The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center.

Подробное описание

This is a 4-day randomized double-blinded intervention study of 30 treatment seeking adults with alcohol use disorder, who are receiving alcohol detoxification treatment at the Hospital of the University of Pennsylvania, Cedar Detox Center. Within 24 hours of admission to the inpatient unit, participants will be consented and randomized to receive 3x daily of 12g of KS (n=15; 1,3-butanediol and D-hydroxybutyric acid from Kenetik, VitaNav Inc., Washington D.C.) for 4 days or placebo beverage (n=15). Benzodiazepines and other "comfort" medications will be administered daily following the HUP Cedar withdrawal management protocol, with benzodiazepines administered based on withdrawal symptoms, monitored with the revised Clinical Institute Withdrawal Assessment for Alcohol. The revised Clinical Institute Withdrawal Assessment for Alcohol is given three or more times a day clinically to determine patient withdrawal levels and adjust medication dosages. Total daily maximum revised Clinical Institute Withdrawal Assessment for Alcohol scores, benzodiazepine dosage, and other "comfort" medications will be analyzed with a repeated measures design, with a binary factor for intervention, factor of time, and intervention by time interaction. Daily mood questions and alcohol craving questions will assess differences between treatment groups. After 4 days of study intervention, all participants will undergo an approximately 1.5-hr. magnetic resonance imaging session.

Вмешательства

• Пищевая добавка ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,
  ketone supplement
• Диагностический тест magnetic resonance imaging session
  1.5 hour magnetic resonance imaging session
• Пищевая добавка Placebo beverage
  Placebo beverage, visually matched, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.

Первичные конечные точки

• Group changes in the total milligrams of benzodiazepines given to subjects during alcohol withdrawal management after receiving either ketone supplement or placebo beverage after 4 days of study intervention. [Срок оценки: 4 days]

Вторичные конечные точки (2)

• To measure the group differences of BHB levels in millimoles, in subjects receiving ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention. [Срок оценки: 4 days]
• To measure the group differences of Gamma-Aminobutyric Acid levels in millimoles in subjects receiving a ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention. [Срок оценки: 4 days]

Критерии участия

Критерии включения

• Able to communicate English and provide written informed consent
• Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
• Minimum 3-year history of heavy drinking (self-report).
• Presence of alcohol withdrawal (DSM-5)

Критерии исключения

• Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.
• Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history and physical exam.
• Clinically significant laboratory findings that could affect brain function (e.g., HIV+)
• Head trauma with loss of consciousness for more than 30 minutes,
• Pregnant or breast-feeding
• BMI greater than 35
• Self-reported claustrophobia
• Contraindications to MRI (e.g., metal in the body that cannot be removed).
• Current, gastrointestinal (GI), liver or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
• Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
• Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Center for Studies of Addiction — Philadelphia

Идентификаторы

NCT: NCT06559995 · 856689 · 5R21AA031337

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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