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Completed

NCT Number: NCT01780805

Second Young Adult Naturalistic Alcohol Study

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.

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Key information

Conditions

Young Adult Alcohol Drinking

Age range

21 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Primary outcomes

  1. Peak estimated blood alcohol concentration

    Time frame: During a 3-hour alcohol drinking period

Secondary outcomes

  1. Number of alcoholic drinks consumed

    Time frame: During a 3-hour alcohol drinking period

Other outcomes

  1. Self-reported drinks per drinking day

    Time frame: 6- and 12-month follow-ups after alcohol drinking session

  2. Self-reported frequency of heavy drinking days

    Time frame: 6- and 12-month follow-up after alcohol drinking session

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Second Young Adult Naturalistic Alcohol Study (YANAS-2)

Acronym: YANAS-2

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 31, 2013
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.