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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063166
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : January 21, 2016
Indiana University School of Medicine
Information provided by (Responsible Party):
Technische Universität Dresden

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.

Condition or disease

Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : June 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : December 2015

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U.S. FDA Resources

Primary Outcome Measures :
  1. Alcohol consumption [ Time Frame: 2 years ]
    Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.

Secondary Outcome Measures :
  1. Alcohol Use Disorders [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 19 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Residents living within 15 km (9.5 miles) from downtown Dresden

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01063166

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Indiana University School of Medicine
Principal Investigator: Ulrich S Zimmermann, Dr. Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Responsible Party: Technische Universität Dresden Identifier: NCT01063166     History of Changes
Other Study ID Numbers: U01 AA017900 SA1
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Underage Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Drinking
Drinking Behavior