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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Alcohol, Behavior, and Brain Imaging

Clinicaltrials.gov identifier NCT03930446

Recruitment Status Completed

First Posted April 29, 2019

Last update posted April 29, 2020

Study Description

Brief summary:

To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.

  • Condition or Disease:Alcohol Drinking
    Binge Drinking
    Drinking Behavior
    Substance-Related Disorders
    Ethanol
    Physiological Effects of Drugs
    Central Nervous System Depressants
  • Intervention/Treatment: Drug: Ethanol
    Other: Placebo
  • Phase: Early Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 80 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Basic Science
  • Official Title: Alcohol, Behavior, and Brain Imaging
  • Actual Study Start Date: January 2016
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Ethanol
Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).
Drug: Ethanol
The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water
Placebo Comparator: Placebo (Juice)
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Other: Placebo
The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.
Outcome Measures
  • Primary Outcome Measures: 1. Change in stop reaction time - Stop Signal Task [ Time Frame: Day 1, 3, 5, 7, 9, ]
    Stop Task measures behavioral inhibition of a prepotent response. Participants are required to respond as quickly as possible when a 'go' target appears and to inhibit that response when a 'stop' signal (an auditory tone) occasionally occurs. The duration of the delay to presentation of the stop signal following the go signal is adjusted until the participant is able to successfully inhibit the response on 50% of trials. The final mean delay of the stop signal, based on this 50% success rate criterion, is subtracted from the mean go reaction time, providing the stop reaction time (stop RT), which is the primary measure of impulsive action.
Eligibility Criteria
  • Ages Eligible for Study: 21 to 29 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- 21-29 years old

- 7-30 alcoholic drinks per week (as reported on PHQ or TLFB)

- At least one binge episode (4 for females/5 for males) per month

- No 'flushing' reaction to alcohol

- Females must be on birth control or in the beginning of follicular phase (1-14 days
after start of menstruation)

- BMI 19-26

- High school education or greater, fluent in English

- No night shift work

- No current or past year Axis I psychiatric disorder including drug/alcohol dependence

- No current psychopharmacological treatment

- No lifetime ADHD or prescription for ADHD medication

- No abnormal EKG, cardiovascular illness, high blood pressure

- No medical condition or pharmacological treatment for which alcohol is contraindicated

- Not pregnant, lactating, or planning to become pregnant

- Smoke <6 cigarettes per day - No previous participation in studies that have used the Stop Task (except IDAC) o Previous Stop Task studies: GOI, CAP, STEM, JAM, MACI, PAC, CAM

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator: Jessica Weafer University of Chicago

More Information
  • Responsible Party: University of Chicago
  • ClinicalTrials.gov Identifier: NCT03930446 History of Changes
  • Other Study ID Numbers: IRB16-0015
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: April 29, 2020
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Substance-Related Disorders
    Binge Drinking
    Alcohol Drinking
    Drinking Behavior