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

NCT ID: NCT01063166

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Alcoholism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrich S Zimmermann, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Locations

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Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Dresden, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 32584051 (View on PubMed)

Other Identifiers

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U01AA017900

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01 AA017900 SA1

Identifier Type: -

Identifier Source: org_study_id

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