- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06519
- Yale University School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Young adult alcohol drinkers
Young adults between the ages of 21-25 who regularly drink alcohol
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Peak estimated blood alcohol concentration
Tidsramme: During a 3-hour alcohol drinking period
|
During a 3-hour alcohol drinking period
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of alcoholic drinks consumed
Tidsramme: During a 3-hour alcohol drinking period
|
During a 3-hour alcohol drinking period
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Self-reported drinks per drinking day
Tidsramme: 6- and 12-month follow-ups after alcohol drinking session
|
6- and 12-month follow-ups after alcohol drinking session
|
Self-reported frequency of heavy drinking days
Tidsramme: 6- and 12-month follow-up after alcohol drinking session
|
6- and 12-month follow-up after alcohol drinking session
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Robert F Leeman, Ph.D., Yale University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1209010754
- R03AA022232 (U.S. NIH-stipend/kontrakt)
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