Second Young Adult Naturalistic Alcohol Study

Completed

• Conditions: Young Adult Alcohol Drinking

• Registration Number: NCT01780805
• Lead Sponsor: Yale University

Brief Summary

This study involves completion of questionnaires, computer-based cognitive tasks and an alcohol drinking session. Participation in this study consists of an initial, in-person screening appointment, 4 brief daily appointments at the research office, an alcohol drinking session at a local bar and a follow-up appointment 1-3 days after the alcohol drinking session.

Participants who are found to be eligible in the screening phase will then complete a daily appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on which they will not attend an appointment). Each appointment will last 20 minutes, on average and consist of a questionnaire and computer-based cognitive task. On the day of the fourth appointment, participants will complete an alcohol drinking session. The alcohol drinking session begins at 4pm and lasts until at least midnight.

Participants in this study will be young adults between the ages of 21-25, who regularly drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two participants will complete this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-31
• Primary Completion: 2015-11
• Study Completion: 2016-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Be between the ages of 21-25.
• Be able to read English and complete study evaluations.
• Drink alcohol on a regular basis

Read More

Exclusion Criteria

No participant may:

• Be seeking treatment for alcohol or other addictive behaviors or have been in inpatient or intensive outpatient treatment within the past 12 months.
• Provide two positive breath alcohol concentration (BAC) readings (i.e., > 0.00%) at any of the following times: in-person screening, a pre-session screening, or at the outset of an alcohol self-administration session. After participants blow their first positive BAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BAC, they will be excluded from this study and offered referrals for alcohol treatment.
• Have positive urine screen results at the in-person screening or pre-session screening on the day of an alcohol self-administration session for opiates, cocaine, phencyclidine, amphetamines, methamphetamine, barbiturates, methadone or benzodiazepines.
• A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.
• Fail to perform at a normative level at screening on any of the four cognitive and psychomotor tasks administered in this study. Participants must perform within two standard deviations of the mean from the samples in relevant prior studies
• Perform computer tasks initially administered at baseline in either a random or inordinately slow fashion
• A body mass index lower than 18.5 or greater than 35.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak estimated blood alcohol concentration	During a 3-hour alcohol drinking period

Secondary Outcome Measures

Name	Time	Method
Number of alcoholic drinks consumed	During a 3-hour alcohol drinking period

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States