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- Klinische proef NCT01780805
Second Young Adult Naturalistic Alcohol Study (YANAS-2)
Second Young Adult Naturalistic Alcohol Study (YANAS-2)
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06519
- Yale University School Of Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
|---|
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Young adult alcohol drinkers
Young adults between the ages of 21-25 who regularly drink alcohol
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Peak estimated blood alcohol concentration
Tijdsspanne: During a 3-hour alcohol drinking period
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During a 3-hour alcohol drinking period
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of alcoholic drinks consumed
Tijdsspanne: During a 3-hour alcohol drinking period
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During a 3-hour alcohol drinking period
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Self-reported drinks per drinking day
Tijdsspanne: 6- and 12-month follow-ups after alcohol drinking session
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6- and 12-month follow-ups after alcohol drinking session
|
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Self-reported frequency of heavy drinking days
Tijdsspanne: 6- and 12-month follow-up after alcohol drinking session
|
6- and 12-month follow-up after alcohol drinking session
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Robert F Leeman, Ph.D., Yale University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1209010754
- R03AA022232 (Subsidie/contract van de Amerikaanse NIH)
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