Second Young Adult Naturalistic Alcohol Study (YANAS-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Leeman, Yale University
ClinicalTrials.gov Identifier:
NCT01780805
First received: January 24, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition
Young Adult Alcohol Drinking

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Second Young Adult Naturalistic Alcohol Study (YANAS-2)

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Peak estimated blood alcohol concentration [ Time Frame: During a 3-hour alcohol drinking period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of alcoholic drinks consumed [ Time Frame: During a 3-hour alcohol drinking period ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Self-reported drinks per drinking day [ Time Frame: 6- and 12-month follow-ups after alcohol drinking session ] [ Designated as safety issue: No ]
  • Self-reported frequency of heavy drinking days [ Time Frame: 6- and 12-month follow-up after alcohol drinking session ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Young adult alcohol drinkers
Young adults between the ages of 21-25 who regularly drink alcohol

  Eligibility

Ages Eligible for Study:   21 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780805

Contacts
Contact: Robert F Leeman, Ph.D. 203-974-7373 robert.leeman@yale.edu
Contact: Christine Nogueira, B.A. 203-974-5765 christine.nogueira@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Robert F Leeman, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Robert Leeman, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01780805     History of Changes
Other Study ID Numbers: 1209010754
Study First Received: January 24, 2013
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on September 22, 2014