IDEA: Impulsivity and Alcohol Response

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT03736343
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), American Psychological Association (Other)
30
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2
39
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Study Details

Study Description

Brief Summary

Impulsivity, a well-known risk factor predicting negative outcomes, refers broadly to a proclivity towards rapid action with a suboptimal regard for future consequences. Importantly, impulsivity is a multidimensional construct incorporating generalized and behavioral facets. However, underlying mechanisms linking facets of impulsivity to high-risk drinking remain uncertain. Such mechanisms, if uncovered, may be more appropriate intervention targets than impulsivity directly.

Similar to impulsivity, subjective response to alcohol (SR), or individual differences in sensitivity to the pharmacologic effects of alcohol, is an established risk factor for alcohol use disorder. Specifically, experiencing heightened rewarding stimulation and dampened aversive sedation from alcohol are related to high-risk drinking. Theory and recent findings indicate SR and impulsivity may be related, suggesting SR may be a mechanism linking facets of impulsivity to high-risk drinking. However, findings linking impulsivity to SR were all from secondary data analyses and most studies reported on only a single measure of impulsivity. For these reasons, an original data collection using laboratory alcohol administration methods is needed to address which facets of impulsivity are related to SR among young adult drinkers and whether these effects manifest while blood alcohol concentrations are increasing or declining.

This study will utilize a laboratory alcohol administration design to investigate whether distinct facets of impulsivity (i.e., generalized, choice, response) are related to subjective responses (i.e., stimulation and sedation) following alcohol administration.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Young adult heavy drinkers, aged 21-30, will enroll in a laboratory alcohol administration study. In a simulated bar laboratory, participants will be administered oral alcohol with three vodka-based drinks. This procedure will allow collection of several measures, notably a widely used, validated measure of self-reported SR and multiple measures capturing facets of impulsive behavior prior to and following alcohol administration. Participants will be recruited through a number of means. Flyers will be posted and handed out in and around the various colleges, universities and technical schools in the Gainesville area as well as in other public areas. The study team will utilize the internet by posting brief solicitation messages on social media, newspaper sites, and classified advertising sites. These same brief messages will also be disseminated to students at the local colleges, universities and technical schools in the area via batch emails and list servs. When permitted, brief recruitment talks will be given verbally during class meetings at these local institutions. Verbal recruitment messages will contain the same material in the appended flyers and other advertisements. Copies of flyers will also be provided at the conclusion of these brief recruitment talks. Potential participants will complete an initial eligibility questionnaire over the phone or online. Participants who appear eligible based on the phone/web screen will be invited to attend an in-person screening appointment. If eligible, participants will be scheduled for two alcohol drinking sessions separated by a minimum of one and a maximum of seven days. After the second drinking session, participants will be scheduled for a follow-up appointment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Individual Differences in the Effects of Alcohol (IDEA) Study
Actual Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Young Adult Heavy Drinkers Group 1

Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol.

Drug: Alcohol
Participants will complete two drinking sessions.
Other Names:
  • 80-proof Vodka Mixed Drinks
  • Active Comparator: Young Adult Heavy Drinkers Group 2

    Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol.

    Drug: Alcohol
    Participants will complete two drinking sessions.
    Other Names:
  • 80-proof Vodka Mixed Drinks
  • Outcome Measures

    Primary Outcome Measures

    1. Biphasic Alcohol Effects Scale [Up to 6 hours]

      Biphasic Alcohol Effects Scale is a 14-item, 2-factor model including stimulant and sedative alcohol effects. The minimum value for each of the 2 factors is 0 and the maximum is 70. Higher scores indicate greater stimulation and sedation for each factor, respectively.

    Secondary Outcome Measures

    1. Subjective Effects of Alcohol Scale [Up to 6 hours]

      The Subjective Effects of Alcohol Scale is a 14-item, 4-factor model including low and high arousal positive and negative alcohol effects. The current study assesses specifically high arousal negative (e.g., aggressive) and low arousal positive (e.g., relaxed) alcohol effects.The factor concerning high arousal negative alcohol effects ranges from 0 - 30, with higher scores indicating greater high arousal negative alcohol effects (e.g., aggression). The factor concerning low arousal positive alcohol effects ranges from 0 - 40, with higher scores indicating greater low arousal positive alcohol effects (e.g., relaxed).

    2. Alcohol Reward [Up to 6 hours]

      The Drug Effects Questionnaire will be used to assess the extent to which participants like the effects of alcohol they are experiencing at the time, rated on a 100-mm line (from "not at all" to "very much") and how much they want more alcohol at the time, also rated on a 100-mm line (from "not at all" to "very much").

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Be between the ages of 21-30

    • Be able to read English and complete study evaluations

    • Drink alcohol regularly

    • Be willing to consume vodka-based alcoholic beverages

    Exclusion Criteria:
    • Have positive urine screen results at the in-person screening or on the day of an alcohol drinking session for illegal drugs

    • A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.

    • A current undergraduate or graduate student at any level in one of the departments that make up the College of Health and Human Performance (HHP) at the University of Florida (UF), where Dr. Leeman's faculty appointment is.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EDGE Lab Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    • American Psychological Association

    Investigators

    • Principal Investigator: Robert Leeman, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT03736343
    Other Study ID Numbers:
    • IRB201801192 - N
    • 1T32AA025877-01A1
    • OCR16172
    • 5T32AA025877-04
    First Posted:
    Nov 9, 2018
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University of Florida
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 5, 2021