Prospective Assessment of Adolescent Drinking Trajectorie... | NCT01063166

Studies
Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)

NCT01063166

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Jan 21, 2016Estimated

Enrollment

96Actual

Phase

Not provided

Conditions

Alcoholism

Interventions

Not provided

Countries

Germany

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
U01AA017900	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2016

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

Jun 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 4, 2010

First Submission Date that Met QC Criteria

Feb 4, 2010

First Posted Date

Feb 5, 2010Estimated

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

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Name	Class
Indiana University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The Computer-Assisted Self-administration of Ethanol (CASE)will be administered twice, at the ages 18 and 20, in a prospective study of 80 adolescents living in the Dresden area. The sample will be recruited for a differential family history of alcoholism (FHA) and gender, with inventories of alcohol use disorder (AUD) symptoms and personal recent drinking history (RDH) obtained prior to each CASE session.

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

Not provided

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

96Actual

Measure	Description	Time Frame
Alcohol consumption	Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.	2 years

Measure	Description	Time Frame
Alcohol Use Disorders		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(a) male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
(b) written informed consent by the subject;
(c) habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
(d) at least one prior experience of alcohol intoxication
(e) being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
(f) effective contraception in female participants;
(g) consenting to abstain from any illegal substance use for 2 weeks prior to participation;
(h) living within 15 km (9.5 miles) from downtown Dresden;
(i) sufficient information concerning alcohol use in both parents and in at least four second-degree relatives

Exclusion Criteria:

(a) prior medical treatment due to alcohol use;
(b) current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
(c) current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
(d) current or prior history of alcohol-induced flushing reactions;
(e) positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;
(f) light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;
(g) intention to become pregnant
(h) pregnancy or positive urine pregnancy screening or breast-feeding;
(i) any alcohol intake on the test day or the day before;
(k) use of medications known to interact with alcohol within 2 weeks of the study;
(l) positive hepatitis or HIV at screening, provided the subject consented to these tests

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

19 Years

Standard Ages

Adult

Study Population

Residents living within 15 km (9.5 miles) from downtown Dresden

Sampling Method

Probability Sample

Name	Affiliation	Role
Ulrich S Zimmermann, Dr.	Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden		Dresden	Saxony	01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32584051	Derived	Obst E, Bernhardt N, Gan G, Plawecki MH, O'Connor S, Smolka MN, Zimmermann US. Sensation seeking, impulsivity, and aggression moderate sex effects on adolescent laboratory binging. Psychol Addict Behav. 2021 Mar;35(2):208-214. doi: 10.1037/adb0000651. Epub 2020 Jun 25.

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders