Young Adult Alcohol Drinking Clinical Trial
— YANAS-2Official title:
Second Young Adult Naturalistic Alcohol Study (YANAS-2)
| Verified date | March 2020 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | October 2016 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 25 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Yale University School of Medicine | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Self-reported drinks per drinking day | 6- and 12-month follow-ups after alcohol drinking session | ||
| Other | Self-reported frequency of heavy drinking days | 6- and 12-month follow-up after alcohol drinking session | ||
| Primary | Peak estimated blood alcohol concentration | During a 3-hour alcohol drinking period | ||
| Secondary | Number of alcoholic drinks consumed | During a 3-hour alcohol drinking period |