Impaired Risk Awareness During Intoxication in DUI Offenders

NCT05247788 | Completed Results

• 2 other identifiers: 60239R01AA028447
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use

Keywords

Social drinker

Outcome Measures

Primary Outcomes (7)

• Mean Number of Alcohol Binges

  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).

  Baseline, 30 and 60 days post intervention

• Mean Penn Alcohol Craving Scale (PACS) at Baseline

  Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.

  Baseline

• Mean Penn Alcohol Craving Scale (PACS) Post Intervention

  Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.

  Post Intervention (up to 14 days)

• Mean Penn Alcohol Craving Scale (PACS) Post Intervention

  Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.

  30 Days Post-Intervention

• Mean Penn Alcohol Craving Scale (PACS) Post Intervention

  Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.

  60 Days Post-Intervention

• Mean Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) Scale

  The Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) is a 37-item self-report measure of 8 dimensions of self-perceived interoceptive ability. The dimensions are: Notice (awareness of uncomfortable, comfortable, or neutral body sensations), Not Distracted (tendency not to ignore or distract oneself from sensations of pain or discomfort), Not Worried (tendency not to worry or experience emotional distress with sensations of pain or discomfort), Attention Regulation (ability to sustain and control attention to body sensations), Emotion (awareness of the connection between body sensations and emotional states), Self-Regulation (ability to regulate distress by attention to body sensations), Body (tendency to actively "listen" to the body for insight), and Trust (experience of one's body as safe and trustworthy). The minimum score for each of the eight dimensions is 0 while the maximum score is 5, with higher scores indicating better outcomes/greater interoception.

  Baseline (Intervention Session)

• Mean Multidimensional Assessment of Interoceptive Awareness (MAIA) Scale

  The Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) is a 37-item self-report measure of 8 dimensions of self-perceived interoceptive ability. The dimensions are: Notice (awareness of uncomfortable, comfortable, or neutral body sensations), Not Distracted (tendency not to ignore or distract oneself from sensations of pain or discomfort), Not Worried (tendency not to worry or experience emotional distress with sensations of pain or discomfort), Attention Regulation (ability to sustain and control attention to body sensations), Emotion (awareness of the connection between body sensations and emotional states), Self-Regulation (ability to regulate distress by attention to body sensations), Body (tendency to actively "listen" to the body for insight), and Trust (experience of one's body as safe and trustworthy). The minimum score for each of the eight dimensions is 0 while the maximum score is 5, with higher scores indicating better outcomes/greater interoception.

  Post Intervention (up to 14 days)

Study Arms (2)

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).

Behavioral: Blood alcohol concentration (BAC) discrimination training; Behavioral: Performance feedback training

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.

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

Interventions

Blood alcohol concentration (BAC) discrimination training BEHAVIORAL

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.

Intoxicated risk awareness training session

Performance feedback training BEHAVIORAL

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).

Intoxicated risk awareness training session

Blood alcohol concentration (BAC) discrimination training for controls BEHAVIORAL

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.

Alcohol exposure only

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mark Fillmore: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Blood Alcohol Content; Bacitracin

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ethanol; Alcohols; Organic Chemicals; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Mark Fillmore
• Organization: University of Kentucky

fillmore@uky.edu

8592574728

Study Officials

• Mark Fillmore, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 21, 2022
• Study Start: February 2, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-03

Locations

US (1)