Acceptability and Feasibility Study of Non-alcoholic Beverages

Официальное название

Non-alcoholic Beverages as a Therapeutic Adjunct in Alcohol Use Disorder Treatment: a Pilot Study of Acceptability and Feasibility

Обзор

This project will elucidate the acceptability and feasibility of incorporating provision of non-alcoholic beers into alcohol use disorder treatment, for patients interested in using non-alcoholic beers as part of their recovery from alcohol use disorder.

Вмешательства

• Другое Non-alcoholic beer
  Participants will receive non-alcoholic beers and will be encouraged to consume the beverages to the extent they find useful/desirable during the 6-week study period.
• Другое Sparkling water
  Participants will receive sparkling water and will be encouraged to consume the beverages to the extent they find useful/desirable during the 6-week study period.

Первичные конечные точки

• Participant Beverage Satisfaction (Acceptability) [Срок оценки: Assessed at the end of week 6]
• Participant Intention to Consume Assigned Beverage in the Future (Acceptability) [Срок оценки: Assessed at the end of week 6]
• Participant Likelihood of Recommending Beverage (Acceptability) [Срок оценки: Assessed at the end of week 6]
• Screened Out of Contacted (Feasibility) [Срок оценки: Beginning of recruitment to end of recruitment (approximately 3-6 months)]
• Eligible Out of Screened (Feasibility) [Срок оценки: Beginning of recruitment to end of recruitment (approximately 3-6 months)]
• Enrolled Out of Eligible (Feasibility) [Срок оценки: Beginning of recruitment to end of recruitment (approximately 3-6 months)]
• Retention (Feasibility) [Срок оценки: Beginning of recruitment to end of data collection (approximately 3-6 months)]
• Perception of Beverage Supply (Feasibility) [Срок оценки: Assessed at the end of week 6]

Вторичные конечные точки (8)

• Average Blood Alcohol Content Across 6 Weeks [Срок оценки: Study weeks 1-6]
• Change in Blood Alcohol Content Across 6 Weeks [Срок оценки: Treatment entry to week 6]
• Average Number of Days with Breathalyzer Readings [Срок оценки: Assessed at 6 weeks.]
• Median Number of Breathalyzer Readings Among Days with Readings [Срок оценки: Assessed at 6 weeks.]
• Change in Reported Alcohol Use [Срок оценки: Baseline to 6 weeks.]
• Perceived Change in Craving [Срок оценки: Assessed at 6 weeks.]
• Perceived Change in Alcohol Use [Срок оценки: Assessed at 6 weeks.]
• Perceived Impact of Beverages on Recovery [Срок оценки: Assessed at 6 weeks.]

Критерии участия

Критерии включения

Participants will be eligible if they report on the screening survey:

• living in California and provide a California mailing address (to ship study materials to)
• consuming ≤42 alcoholic beverages per week (as we seek to provide an equal count of the substitute beverage and budgetary restrictions prevent an amount greater than that)
• having alcohol use disorder documented with ≥2 symptoms on the Alcohol Symptom Checklist
• being enrolled in Ria Health treatment
• having English language fluency

Критерии исключения

• Individuals will be excluded at the online screener survey stage if they do not meet all of the inclusion criteria.

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

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Stanford Prevention Research Center — Stanford

Идентификаторы

NCT: NCT07451574 · 83997 · 1K99AA031716

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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