Second Young Adult Naturalistic Alcohol Study

NCT01780805 | Completed DMC

• 2 other identifiers: 1209010754R03AA022232
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Young Adult Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• Peak estimated blood alcohol concentration

  During a 3-hour alcohol drinking period

Secondary Outcomes (1)

• Number of alcoholic drinks consumed

  During a 3-hour alcohol drinking period

Other Outcomes (2)

• Self-reported drinks per drinking day

  6- and 12-month follow-ups after alcohol drinking session

• Self-reported frequency of heavy drinking days

  6- and 12-month follow-up after alcohol drinking session

Study Arms (1)

Young adult alcohol drinkers

Young adults between the ages of 21-25 who regularly drink alcohol

Eligibility Criteria

• Age: 21 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy young adults between the ages of 21-25 years of ago who regularly drink alcohol and are not currently seeking treatment for alcohol.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Study Officials

• Robert F Leeman, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: October 1, 2016
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

US (1)