Multi-Method Investigation of Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Drug Effect Questionnaire (DEQ)
研究概览
简要总结
The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 200 young adults who drink alcohol frequently will take part in the study. This research is being funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Participation involves one in-person screening session with a same-sex platonic friend. Then participants will complete four in-person laboratory sessions where they will drink beverages containing alcohol or no alcohol. After completion of the laboratory sessions, participants will complete smartphone surveys for 28 days. Lastly, they will complete follow-up surveys 6 months and 12 months post-study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-28 years of age
- •Drink regularly (1+ times/week) with a same-sex platonic friend that also meets eligibility and is willing to participate
- •Regular alcohol use (3+ times/week) with at least one binge drinking episode (5+ drinks [male] or 4+ drinks [female] in about 2 hours) in the past month
- •BMI of 18-30
- •Own a smart device operating on the iOS or Android operating system
- •Fluent in English
排除标准
- •Pregnancy or breastfeeding or intent to get pregnant in the next 60 days (females)
- •medical conditions counter-indicated for alcohol administration
- •seeking treatment for alcohol use
研究组 & 干预措施
Laboratory alcohol administration with longitudinal follow-ups
All participants will be in this single arm, which consists on behavioral testing of alcohol administration in the lab, followed by longitudinal follow-ups using Ecological Momentary Assessment and surveys.
干预措施: Alcohol (Oral) (Drug)
结局指标
主要结局
Drug Effect Questionnaire (DEQ)
时间窗: The DEQ will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
The Drug Effects Questionnaire (DEQ), a 5-item visual analog questionnaire (0 to 100 mm; not at all to extremely), will be used to assess the extent to which participants experience the effects of the drug: "feel drug," "feel high," "like drug," "dislike drug," and "want more".
Biphasic Alcohol Effects Scale (BAES)
时间窗: The BAES will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
The Biphasic Alcohol Effects Scale (BAES) is a 14-item survey that instructs individuals to rate the extent to which drinking alcohol has produced related subjective effects (0=not at all to 10=extremely). This questionnaire has two subscales consisting of mean scores related to sedation and stimulation.
Quantity of Alcohol Use during Ecological Momentary Assessment
时间窗: Quantity of Alcohol Use will be assessed daily for 28 days.
Quantity of alcohol use will be the number of drinks reported each day during the Ecological Momentary Assessment period. Number of drinks reported will be recoded to create two binary variables alcohol use (alcohol use \[1+ drinks\], no alcohol \[0\]) and binge drinking (binge \[female: 4+ drinks; male: 5+ drinks\], no binge (female: \<4 drinks; male\<5 drinks\]).
Past 30-day Alcohol Use during Follow-Up
时间窗: Past 30-day alcohol use will be assessed 6 and 12 months after the initial laboratory sessions.
Past 30-day alcohol use (including number of drinks and binge drinking) will be assessed using the timeline follow-back method.
次要结局
- Positive and Negative Affect Schedule (PANAS)(The PANAS will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.)
- Brief Young Adult Alcohol Consequences Questionnaire (YAACQ) during Ecological Momentary Assessment(The YAACQ will be completed daily for 28 days.)
- Past 30-day Alcohol Consequences during Follow-Up(Past 30-day alcohol consequences will be assessed at 6 and 12 months following the initial laboratory sessions.)
研究者
Matthew Kirkpatrick
Associate Professor
University of Southern California