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临床试验/NCT05247788
NCT05247788已完成不适用

Impaired Risk Awareness During Intoxication in DUI Offenders

Mark Fillmore2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2022年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
2
主要终点
Change in alcohol consumption

研究概览

简要总结

This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use.

详细描述

This project examines the efficacy of a laboratory-based intervention to increase risk awareness of DUI offenders during states of acute alcohol intoxication. The proposed research will test the efficacy of an innovative experiential-based training approach to improve DUI offenders' ability to appraise their level of intoxication and enhance their risk awareness. DUI offenders will undergo experiential-based training in which they are administered a controlled dose of alcohol and receive structured feedback and mindfulness-based training to accurately appraise the impairing effects of alcohol and estimate their breath alcohol concentration. The research tests the hypothesis that the experiential training will increase DUI offenders' risk awareness in the intoxicated state as evident by reduced disinhibition and risk-taking behavior in response to alcohol, and reduced self-reported alcohol consumption over a follow up period.

A total of 60 DUI offenders and 60 non-offender controls will be recruited. The study tests the degree to which acute alcohol intoxication impairs key indicators of risk awareness in DUI offenders and the efficacy of experiential feedback to increase risk awareness during intoxication. Two key indicators of impaired risk awareness will be assessed during intoxication: 1) increased disinhibition/risk-taking and; 2) reduced perception of intoxication. Two main hypotheses are tested. Hypothesis 1: Prior to training, DUI offenders will display greater disinhibition/risk-taking and less perceived impairment in response to alcohol compared with controls. Hypothesis 2: Experiential feedback training will increase intoxicated risk awareness among DUI offenders as evident by reduced disinhibiting and risk-taking effects in response to alcohol and increased perception of impairment and accuracy of BAC estimation. Offenders and controls will undergo a pre-training assessment of their responses to a controlled dose of 0.65 g/kg alcohol versus a placebo on the two key indicators of risk awareness: disinhibition/risk-taking and perceived intoxication. Experiential feedback training sessions will begin within one week of completing the pre-training assessment of intoxicated risk awareness. Subjects will attend two training sessions in which they are administered a controlled dose of alcohol and receive structured training to accurately estimate their breath alcohol concentration and accurately appraise the behavioral impairing effects of alcohol. Half of the DUI offenders (20 men and 10 women) will be randomly assigned to the training condition and the other half assigned to an alcohol-exposure-only "control" condition. Non-offender, control subjects will undergo the same group assignment procedure. After completing the two training sessions all subjects will be re-tested on the two indicators of risk awareness in response to 0.65 g/kg alcohol: disinhibition/risk-taking and perceived intoxication. The post-training assessment of alcohol responses is identical to the pre-training assessment and will be conducted at 2 time points: 1-week post-training and 3 months post-training, to evaluate retention effects. Alcohol consumption also will be assessed at monthly intervals over the 3 month follow-up to evaluate the training efficacy to reduce high-risk patterns of consumption (e.g., binge episodes).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Valid driver's license for at least 5 years
  • Drive regularly (weekly basis)

排除标准

  • History of physical or psychiatric disease
  • Pregnancy
  • Breastfeeding
  • Substance use disorder (other than nicotine or caffeine use)

研究组 & 干预措施

Alcohol exposure only

Active Comparator

Participants assigned to the alcohol-exposure-only condition undergo the same alcohol dose exposures over the session but receive a general body scan and do not receive feedback concerning BAC or performance.

干预措施: Blood alcohol concentration (BAC) discrimination training for controls (Behavioral)

Intoxicated risk awareness training session

Experimental

Participants will complete an intoxicated risk awareness training session in which they receive a controlled alcohol dose with structured feedback and training to accurately appraise the impairing effects of alcohol and estimate their blood alcohol concentration (BAC).

干预措施: Blood alcohol concentration (BAC) discrimination training (Behavioral)

Intoxicated risk awareness training session

Experimental

Participants will complete an intoxicated risk awareness training session in which they receive a controlled alcohol dose with structured feedback and training to accurately appraise the impairing effects of alcohol and estimate their blood alcohol concentration (BAC).

干预措施: Performance feedback training (Behavioral)

结局指标

主要结局

Change in alcohol consumption

时间窗: Baseline to follow up [Monthly], up to 3 months

Alcohol consumption will be assessed at monthly intervals from baseline to follow up and will be measured using a timeline follow back assessment. Participants will self-report data on number of days when the participant demonstrates binge drinking (5+ drinks per day for men; 4+ drinks per day for women).

Change in subjects perceive improvement in their interoceptive ability

时间窗: Baseline to follow up [Monthly], up to 3 months

Change in subjects perceive improvement in their interoceptive ability will be assessed by the Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) is a 37-item self-report measure of eight dimensions of self-perceived interoceptive ability. MAIA-2 uses a 0-5 point Likert scale (0=never, 5=always) where higher values indicate a better outcome.

Change in tonic alcohol cravings

时间窗: Baseline to follow up [Monthly], up to 3 months

Change in tonic alcohol cravings will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics that measures the frequency, intensity, and duration of thoughts about drinking over the past week. PACS uses a 0-6 point Likert scale where a higher number higher cravings. Total scores range from 0 to 30.

次要结局

未报告次要终点

研究者

发起方
Mark Fillmore
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mark Fillmore

Professor

University of Kentucky

研究点 (2)

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