Non-alcoholic Beverages as a Therapeutic Adjunct in Alcohol Use Disorder Treatment: a Pilot Study of Acceptability and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant Beverage Satisfaction (Acceptability)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Individuals will be excluded at the online screener survey stage if they do not meet all of the inclusion criteria.
研究组 & 干预措施
Non-alcoholic beer
Participants will receive non-alcoholic beers (volume matching alcohol volume intake prior to alcohol use disorder treatment enrollment) for 6 weeks.
干预措施: Non-alcoholic beer (Other)
Sparkling water
Participants will receive sparkling water (volume matching alcohol volume intake prior to alcohol use disorder treatment enrollment) for 6 weeks.
干预措施: Sparkling water (Other)
结局指标
主要结局
Participant Beverage Satisfaction (Acceptability)
时间窗: Assessed at the end of week 6
"How satisfied were you with the beverages you received in this study?" with 5-pt scale response options ranging from "Very Unsatisfied" to "Very Satisfied." Higher scores \[split by condition\] will indicate greater acceptability.
Participant Intention to Consume Assigned Beverage in the Future (Acceptability)
时间窗: Assessed at the end of week 6
"Do you intend to consume the beverage type you received in the future?" with 5-pt scale response options ranging from "Definitely not" to "Definitely." Higher scores \[split by condition\] will indicate greater acceptability.
Participant Likelihood of Recommending Beverage (Acceptability)
时间窗: Assessed at the end of week 6
"Would you recommend the use of the beverage type you received for people who have alcohol use disorder?" with 5-pt scale response options ranging from "Definitely not" to "Definitely." Higher scores \[split by condition\] will indicate greater acceptability.
Screened Out of Contacted (Feasibility)
时间窗: Beginning of recruitment to end of recruitment (approximately 3-6 months)
Percentage of participants who completed the screening measure out of those who were contacted. Higher percentage will indicate greater feasibility.
Eligible Out of Screened (Feasibility)
时间窗: Beginning of recruitment to end of recruitment (approximately 3-6 months)
Percentage of participants who screen eligible out of those who were screened. Higher percentage will indicate greater feasibility.
Enrolled Out of Eligible (Feasibility)
时间窗: Beginning of recruitment to end of recruitment (approximately 3-6 months)
Percentage of participants who enrolled out of those who screened eligible. Higher percentage will indicate greater feasibility.
Retention (Feasibility)
时间窗: Beginning of recruitment to end of data collection (approximately 3-6 months)
Percentage of participants who completed the study out of those who enrolled. Higher percentage \[split by condition\] will indicate greater feasibility.
Perception of Beverage Supply (Feasibility)
时间窗: Assessed at the end of week 6
Percentage of participants whose response to "How was the supply of beverages you received throughout the study?" is "just right" \[as opposed to "too little" or "too much"\]. Higher percentage \[split by condition\] will indicate greater feasibility.
Acceptability_FutureConsumption
时间窗: Assessed at the end of week 6 (end of study)
"How likely are you to consume non-alcoholic beers in the future?" with 5-pt scale response options ranging from "Not at all likely" to "Extremely likely"
次要结局
- Average Blood Alcohol Content Across 6 Weeks(Study weeks 1-6)
- Change in Blood Alcohol Content Across 6 Weeks(Treatment entry to week 6)
- Average Number of Days with Breathalyzer Readings(Assessed at 6 weeks.)
- Median Number of Breathalyzer Readings Among Days with Readings(Assessed at 6 weeks.)
- Change in Reported Alcohol Use(Baseline to 6 weeks.)
- Perceived Change in Craving(Assessed at 6 weeks.)
- Perceived Change in Alcohol Use(Assessed at 6 weeks.)
- Perceived Impact of Beverages on Recovery(Assessed at 6 weeks.)
研究者
Molly Anne Bowdring
Instructor
Stanford University