NCT01063166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

February 4, 2010

Last Update Submit

January 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption

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

    2 years

Secondary Outcomes (1)

  • Alcohol Use Disorders

    2 years

Eligibility Criteria

Age18 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • (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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ulrich S Zimmermann, Dr.

    Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2012

Study Completion

December 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations