Clinical trial NCT03736343: Impulsivity and Alcohol Response
Official title: Individual Differences in the Effects of Alcohol (IDEA) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder (AUD)
Subjective Response to Alcohol (SR)
Keywords: impulsivity
family history
heavy drinking
blood alcohol content (BAC)
breath alcohol content (BrAC)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: American Psychological Association
First posted: 2018-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Biphasic Alcohol Effects Scale
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Subjective Effects of Alcohol Scale
timeFrame: Up to 6 hours
measure: Alcohol Reward
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: EDGE Lab
state: Florida
Study officials:
affiliation: University of Florida
name: Yan Wang
role: PRINCIPAL_INVESTIGATOR
References: