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CompletedNCT01063166Updated Jan 21, 2016

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

An observational study in Alcoholism, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-21.

Sponsored by Technische Universität Dresden · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
96
Ages
18 Years to 19 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcoholism
03

Who can participate

Ages eligible
18 Years to 19 Years
Sexes eligible
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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
96 participants (actual)
05

What researchers measure

Primary outcomes

  1. Alcohol consumption

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

    Time frame: 2 years

Secondary outcomes

  1. Alcohol Use Disorders

    Time frame: 2 years

06

Study locations

1 site
  • Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
    Dresden, Saxony 01307, Germany
07

References and documents

Publications

  • 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. PubMed 32584051 ↗
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Registry details

Key details

Study ID
NCT01063166
Lead sponsor
Technische Universität Dresden
Collaborators
Indiana University School of Medicine
Responsible party
Sponsor
First posted
Feb 5, 2010
Start date
Jun 2010
Primary completion
Mar 2012
Completion
Dec 2015
Last update
Jan 21, 2016

Study contacts

Ulrich S Zimmermann, Dr.
principal investigator · Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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