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

Alcoholism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063166
• Other study ID #: U01 AA017900 SA1
• Status: Completed
• Phase: N/A
• First received: February 4, 2010
• Last updated: January 20, 2016
• Start date: June 2010
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2015
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 19 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcoholism

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Indiana University School of Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption	Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.	2 years	No
Secondary	Alcohol Use Disorders		2 years	No