Impulsivity and Alcohol Response (IDEA)
Primary Purpose
Alcohol Use Disorder (AUD), Subjective Response to Alcohol (SR)
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Sponsored by
About this trial
This is an interventional other trial for Alcohol Use Disorder (AUD) focused on measuring impulsivity, family history, heavy drinking, blood alcohol content (BAC), breath alcohol content (BrAC)
Eligibility Criteria
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.
Sites / Locations
- EDGE Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Young Adult Heavy Drinkers Group 1
Young Adult Heavy Drinkers Group 2
Arm Description
Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol.
Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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").
Full Information
NCT ID
NCT03736343
First Posted
November 6, 2018
Last Updated
October 11, 2022
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), American Psychological Association
1. Study Identification
Unique Protocol Identification Number
NCT03736343
Brief Title
Impulsivity and Alcohol Response
Acronym
IDEA
Official Title
Individual Differences in the Effects of Alcohol (IDEA) Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), American Psychological Association
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD), Subjective Response to Alcohol (SR)
Keywords
impulsivity, family history, heavy drinking, blood alcohol content (BAC), breath alcohol content (BrAC)
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Young Adult Heavy Drinkers Group 1
Arm Type
Active Comparator
Arm Description
Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol.
Arm Title
Young Adult Heavy Drinkers Group 2
Arm Type
Active Comparator
Arm Description
Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol.
Intervention Type
Drug
Intervention Name(s)
Alcohol
Other Intervention Name(s)
80-proof Vodka Mixed Drinks
Intervention Description
Participants will complete two drinking sessions.
Primary Outcome Measure Information:
Title
Biphasic Alcohol Effects Scale
Description
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.
Time Frame
Up to 6 hours
Secondary Outcome Measure Information:
Title
Subjective Effects of Alcohol Scale
Description
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).
Time Frame
Up to 6 hours
Title
Alcohol Reward
Description
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").
Time Frame
Up to 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
EDGE Lab
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impulsivity and Alcohol Response
We'll reach out to this number within 24 hrs