Novel Methods for Investigating Stress-related Processes in Social Drinkers and Individuals With Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Rating of subjective craving in the real world
研究概览
简要总结
This research project proposes a novel approach to elucidate the biological adaptations associated with Alcohol Use Disorder and to assess whether such adaptations are predictive of higher alcohol craving in response to both alcohol cues and stressors and higher relapse risk and alcohol use in the real world.
详细描述
We will use intensive longitudinal data collection and analysis across multiple data streams. We will recruit 25 treatment-seeking individuals with AUD and 25 light social drinkers matched on demographically relevant variables (i.e., age, gender, IQ, race). We will use smartphones to assess subjects' alcohol use and experiences in real-time via ecological momentary assessment (EMA). During three consecutive days of these two weeks, we propose using passive biomonitoring to collect real-time cardiovascular responses, i.e., heart rate variability (HRV), and alcohol use via unobtrusive monitors (i.e., Firstbeat Bodyguard 2, BACtrack Skyn) with scheduled salivary cortisol samples. Individuals with AUD will then be provided with four weeks of behavioral treatment with daily assessments. During the final two weeks of treatment, individuals with AUD will complete another three-day period of intensive self-reports, including another 72-hours physiological and salivary cortisol monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who:
- •Are older than 18 years old at the first intake appointment; 2) Are fluent in English; 3) Are drinking alcohol at levels to match either of the two groups:
- •a. Social drinkers: i. Must report a past-year history of alcohol use ii. Must not meet current AUD and may have only met mild AUD during their lifetime (not within the past year) iii. Provide a negative urine toxicology screen. b. Individuals with Alcohol Use Disorder: i. Must meet current criteria for AUD based on the SCID (≤ 2 symptoms in past year); ii. Report at least weekly use of alcohol. iii. Do not meet criteria for any other substance use disorders other than mild Cannabis Use Disorder.
- •iv. Provide a positive urine toxicology screen for alcohol during intake. 5) Can provide written informed consent.
排除标准
- 未提供
结局指标
主要结局
Rating of subjective craving in the real world
时间窗: 42 days for individuals with AUD, 14 days for social drinkers
Participants will report using ecological momentary assessment (EMA) their current levels of craving, if they have drank alcohol, and if they experienced a stressor. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and while drinking alcohol. Individuals with AUD will be compared to social drinkers in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."
Heart rate response to stress and cannabis cues in the real world
时间窗: 6 days for individuals with AUD, 3 days for social drinkers
Heart Rate Variability (HRV) will be collected throughout the day on two (individuals with AUD) or one set (social drinkers) of three-day occasions during intake week and during week 6 of the study.
Cortisol response to stress and cannabis cues in the real world
时间窗: 6 days for individuals with AUD, 3 days for social drinkers
Saliva samples for cortisol levels will be collected throughout the day on two (individuals with AUD) or one set (social drinkers) of three-day occasions during intake week and during week 6 of the study.
Rating of subjective stress in the real world
时间窗: 42 days for individuals with AUD, 14 days for social drinkers
Participants will report using ecological momentary assessment (EMA) their current levels of stress, if they have drank alcohol, and if they experienced a stressor. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and during marijuana use. Individuals with AUD will be compared to social drinkers in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."
次要结局
未报告次要终点