Impulsivity and Alcohol Response (IDEA)

Individual Differences in the Effects of Alcohol (IDEA) Study

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.

Study Overview

• Status: Terminated
• Conditions: Alcohol Use Disorder (AUD); Subjective Response to Alcohol (SR)
• Intervention / Treatment: Drug: Alcohol

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • EDGE Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biphasic Alcohol Effects Scale	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.	Up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Effects of Alcohol Scale	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).	Up to 6 hours
Alcohol Reward	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").	Up to 6 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); American Psychological Association
• Investigators: Principal Investigator: Yan Wang, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: family history; heavy drinking; impulsivity; blood alcohol content (BAC); breath alcohol content (BrAC)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: IRB201801192 - N; OCR16172 (Other Identifier: Universiy of Florida); 5T32AA025877 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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