NCT05247788

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

3.1 years

First QC Date

February 5, 2022

Last Update Submit

August 21, 2025

Conditions

Alcohol Use

Keywords

Social drinker

Outcome Measures

Primary Outcomes (3)

  • 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).

    Baseline to follow up [Monthly], up to 3 months

  • 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.

    Baseline to follow up [Monthly], up to 3 months

  • 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.

    Baseline to follow up [Monthly], up to 3 months

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 trainingBehavioral: 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 trainingBEHAVIORAL

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 trainingBEHAVIORAL

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 controlsBEHAVIORAL

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

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Blood Alcohol ContentBacitracin

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

EthanolAlcoholsOrganic ChemicalsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Mark Fillmore, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

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

August 28, 2025

Record last verified: 2025-08

Locations

US(1)