Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03736343 |
| Other study ID # |
IRB201801192 - N |
| Secondary ID |
OCR161725T32AA02 |
| Status |
Terminated |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2019 |
| Est. completion date |
October 17, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
University of Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
