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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01063166
First received: February 4, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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
Alcoholism

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Alcohol consumption [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.


Secondary Outcome Measures:
  • Alcohol Use Disorders [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: June 2010
Estimated Study Completion Date: March 2016
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063166

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

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01063166     History of Changes
Other Study ID Numbers: U01 AA017900 SA1
Study First Received: February 4, 2010
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014