- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Connecticut
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New Haven, Connecticut, États-Unis, 06519
- Yale University School Of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Young adult alcohol drinkers
Young adults between the ages of 21-25 who regularly drink alcohol
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Peak estimated blood alcohol concentration
Délai: During a 3-hour alcohol drinking period
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During a 3-hour alcohol drinking period
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Number of alcoholic drinks consumed
Délai: During a 3-hour alcohol drinking period
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During a 3-hour alcohol drinking period
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
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Self-reported drinks per drinking day
Délai: 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
Délai: 6- and 12-month follow-up after alcohol drinking session
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6- and 12-month follow-up after alcohol drinking session
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Robert F Leeman, Ph.D., Yale University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1209010754
- R03AA022232 (Subvention/contrat des NIH des États-Unis)
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