Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Официальное название

Effects of Ketone Supplementation on Acute Alcohol Withdrawal Symptoms During Alcohol Withdrawal Management

Обзор

The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the Caron Treatment Center.

Подробное описание

This is a 5 day double-blinded, placebo-controlled intervention study of 50 treatment-seeking individuals with AUD, who are receiving detoxification treatment at Caron Treatment Center. Participants will be recruited for participation within 48 hours of admission to the inpatient unit. Participants will be consented and randomized to receive 10 g of ketone supplement three times daily (n=30; 1,3-butanediol and D-hydroxybutyric acid from Kenetik, VitaNav Inc., Washington D.C.) for 5 days or a placebo beverage (n=20). Benzodiazepines and other "comfort" medications will be administered daily following the Caron withdrawal management protocol, with additional benzodiazepines administered based on withdrawal symptoms, monitored with the revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar). The CIWA-Ar is given three or more times per day clinically to determine patient withdrawal levels and adjust medication dosages. Total daily maximum CIWA-Ar 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 and alcohol craving questions will assess differences between treatment groups.

Вмешательства

• Пищевая добавка Kenetik; Ketone Concentrate
  Ketone Supplement
• Пищевая добавка Isocaloric dextrose placebo
  Drink that is taste and visually matched to Ketone supplement

Первичные конечные точки

• Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg). [Срок оценки: 5 days]

Вторичные конечные точки (1)

• Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores (daily maximum scores). [Срок оценки: 5 days]

Критерии участия

Критерии включения

• Meets current DSM-5 criteria for AUD and admitted for alcohol withdrawal management treatment at Caron Treatment Center
• Willingness to provide signed, informed consent and commit to completing the procedures in the study

Критерии исключения

• 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.
• Currently pregnant or lactating, based on urine pregnancy test and clinical exam.
• 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 · 2 центра

• University of Pennsylvania Center for Studies of Addiction — Philadelphia
• Caron Treatment Center — Wernersville

Идентификаторы

NCT: NCT06173973 · 854682

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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