Impaired Risk Awareness During Intoxication in DUI Offenders
Primary Purpose
Alcohol Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood alcohol concentration (BAC) discrimination training
Performance feedback training
Blood alcohol concentration (BAC) discrimination training for controls
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Use focused on measuring Social drinker
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)
Sites / Locations
- University of KentuckyRecruiting
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intoxicated risk awareness training session
Alcohol exposure only
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Change in alcohol consumption
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 tonic alcohol cravings
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.
Change in subjects perceive improvement in their interoceptive ability
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05247788
First Posted
February 5, 2022
Last Updated
February 3, 2023
Sponsor
Mark Fillmore
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05247788
Brief Title
Impaired Risk Awareness During Intoxication in DUI Offenders
Official Title
Impaired Risk Awareness During Intoxication in DUI Offenders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Fillmore
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use
Keywords
Social drinker
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intoxicated risk awareness training session
Arm Type
Experimental
Arm Description
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).
Arm Title
Alcohol exposure only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Blood alcohol concentration (BAC) discrimination training
Intervention Description
Subjects will receive 0.65 g/kg alcohol to yield a peak BAC of 85 mg/dl (0.085%). They will be trained to accurately estimate their BAC using the Body Scan Exercise with BAC feedback.
Intervention Type
Behavioral
Intervention Name(s)
Performance feedback training
Intervention Description
This training element targets the driver's self-efficacy by increasing their awareness of the behavioral impairing effects of alcohol that are experienced at BACs at and even below the legal limit (50-80 mg/dl).
Intervention Type
Behavioral
Intervention Name(s)
Blood alcohol concentration (BAC) discrimination training for controls
Intervention Description
Subjects will receive 0.65 g/kg alcohol to yield a peak BAC of 85 mg/dl (0.085%). They will be given a general Body Scan Exercise with no feedback.
Primary Outcome Measure Information:
Title
Change in alcohol consumption
Description
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).
Time Frame
Baseline to follow up [Monthly], up to 3 months
Title
Change in tonic alcohol cravings
Description
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.
Time Frame
Baseline to follow up [Monthly], up to 3 months
Title
Change in subjects perceive improvement in their interoceptive ability
Description
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.
Time Frame
Baseline to follow up [Monthly], up to 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
8592575794
Email
psychresearch@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Fillmore, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-257-5794
Email
psychresearch@uky.edu
First Name & Middle Initial & Last Name & Degree
Mark Fillmore, PhD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark T Fillmore, Ph.D.
Phone
859-257-4728
Email
fillmore@uky.edu
12. IPD Sharing Statement
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Impaired Risk Awareness During Intoxication in DUI Offenders
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