AlcoholismNCT01063166
Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)
An observational study of Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents living within 15 km (9.5 miles) from downtown Dresden
Who may be able to join
- (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;
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- (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
Who cannot join
- (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;
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- (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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Dresden, Saxony, 01307
About this study
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
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.
- Conditions
- Alcoholism
- Medical subject headings
- Alcoholism
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.
Measured: 2 years
Secondary outcomes (1)
Alcohol Use Disorders
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Ulrich S Zimmermann, Dr., Principal investigator, Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063166
- Sponsor's protocol ID
- U01 AA017900 SA1
- Other IDs
- U01AA017900
- Status last verified
- Jan 2016
- First submitted
- 4 Feb 2010
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01063166
- Acronym / sponsor ID
- U01 AA017900 SA1
- Conditions
- Alcoholism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents living within 15 km (9.5 miles) from downtown Dresden
Key inclusion criteria (9 listed)
- (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;
Key exclusion criteria (11 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alcohol consumption
Time frame: 2 years
Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.
1 secondary outcome
Alcohol Use Disorders
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Derived from this study: PubMed 32584051Obst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich S Zimmermann, Dr. principal investigator
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.