Impulsivity and Alcohol Response

NCT03736343 | Terminated Early Phase 1 FDA Drug

• 3 other identifiers: IRB201801192 - NOCR161725T32AA025877
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder (AUD); Subjective Response to Alcohol (SR)

Keywords

impulsivity; family history; heavy drinking; blood alcohol content (BAC); breath alcohol content (BrAC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subjective Effects of Alcohol Scale

  Up to 6 hours

• Alcohol Reward

  Up to 6 hours

Study Arms (2)

Young Adult Heavy Drinkers Group 1

ACTIVE COMPARATOR

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

Drug: Alcohol

Young Adult Heavy Drinkers Group 2

ACTIVE COMPARATOR

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

Drug: Alcohol

Interventions

Alcohol DRUG

Participants will complete two drinking sessions.

Also known as: 80-proof Vodka Mixed Drinks

Young Adult Heavy Drinkers Group 1; Young Adult Heavy Drinkers Group 2

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

EDGE Lab

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Alcoholism; Impulsive Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Yan Wang

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 9, 2018
• Study Start: May 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: October 17, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)