Clinical trial NCT05247788: Impaired Risk Awareness During Intoxication in DUI Offenders
Official title: Impaired Risk Awareness During Intoxication in DUI Offenders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
Keywords: Social drinker
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-02-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in alcohol consumption
timeFrame: Baseline to follow up [Monthly], up to 3 months
measure: Change in tonic alcohol cravings
timeFrame: Baseline to follow up [Monthly], up to 3 months
measure: Change in subjects perceive improvement in their interoceptive ability
timeFrame: Baseline to follow up [Monthly], up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Mark Fillmore, PhD
role: PRINCIPAL_INVESTIGATOR
References: