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NCT03736343 · ClinicalTrials.gov registry record · Early Phase 1

Impulsivity and Alcohol Response

A Early Phase 1 study, sponsored by University of Florida.

Terminated
Registry status
Early Phase 1
Development phase
24
Enrollment target

NCT03736343: Clinical Trial Early Phase 1 study, sponsored by University of Florida.

NCT03736343 is a Early Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 24 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03736343, a Early Phase 1 study, was terminated before completion, sponsored by University of Florida.

TERMINATED
Registry status
Early Phase 1
Development phase
24 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Alcohol

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2019-05-01
Est. Completion 2022-10-17
Phase Early Phase 1
University of Florida

1,106 total trials

Why NCT03736343 stopped before completion

NCT03736343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 1 intervention - of which Alcohol is the first listed.

NCT03736343 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03736343 about?

NCT03736343 is a clinical study titled "Impulsivity and Alcohol Response". 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 mech...

What is the current status of trial NCT03736343?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2019-05-01. Estimated completion is 2022-10-17.

What interventions are being tested in trial NCT03736343?

The interventions under investigation include: Alcohol (DRUG).

Who is sponsoring clinical trial NCT03736343?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03736343's enrollment target sits among peer trials

24 1037th of 2000 higher than 913 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03736343, the US trial registry maintained by the National Library of Medicine. NCT03736343 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.