Second Young Adult Naturalistic Alcohol Study | NCT01780805

Studies
Second Young Adult Naturalistic Alcohol Study

NCT01780805

Sponsor

Yale University

Status

Completed

Last Update Posted

Mar 6, 2020Actual

Enrollment

69Actual

Phase

Not provided

Conditions

Young Adult Alcohol Drinking

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R03AA022232	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Nov 2015Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jan 24, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2020

Last Update Posted Date

Mar 6, 2020Actual

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Label	Type	Description	Intervention Names
Young adult alcohol drinkers		Young adults between the ages of 21-25 who regularly drink alcohol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak estimated blood alcohol concentration		During a 3-hour alcohol drinking period

Secondary Outcomes

Measure	Description	Time Frame
Number of alcoholic drinks consumed		During a 3-hour alcohol drinking period

Other Outcomes

Measure	Description	Time Frame
Self-reported drinks per drinking day		6- and 12-month follow-ups after alcohol drinking session
Self-reported frequency of heavy drinking days		6- and 12-month follow-up after alcohol drinking session

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

25 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample