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

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Dresden, Saxony, 01307, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Alcohol consumption

Time frame: 2 years

Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.

Secondary outcomes

Alcohol Use Disorders

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

Indiana University

Registry information

Official study title

Collaboration on Alcohol Self Administration in Adolescents and Young Adults - Specific Aim 1: Assess the Initial Slope of Adolescent Drinking Trajectories, Beginning at the Age of Eighteen

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2015
First posted: Feb 5, 2010
Registry last updated: Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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