AlcoholismNCT01097213
Neural Mechanisms Underlying Alcohol Induced Disinhibition
An observational study of Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1 ("Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)"; ClinicalTrials.gov identifier: NCT01063166). Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- Ethanol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Apr 2012
- 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
- male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
- written informed consent by the subject;
- habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
- at least one prior experience of alcohol intoxication
- being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
- effective contraception in female participants;
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- consenting to abstain from any illegal substance use for 2 weeks prior to participation;
- living within 15 km (9.5 miles) from downtown Dresden;
- sufficient information concerning alcohol use in both parents and in at least four second-degree relatives
Who cannot join
- prior medical treatment due to alcohol use;
- current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
- current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
- current or prior history of alcohol-induced flushing reactions;
- positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;
- light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;
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- intention to become pregnant
- pregnancy or positive urine pregnancy screening or breast-feeding;
- any alcohol intake on the test day or the day before;
- use of medications known to interact with alcohol within 2 weeks of the study;
- positive hepatitis or HIV at screening, provided the subject consented to these tests
- any conditions posing safety issues with the fMRI scan, such as ferromagnetic implants, cardiac pacemakers or insulin pumps
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technische Universitaet Dresden - Dresden fMRT-Neuroimaging Center
Dresden, Saxony, 01187
About this study
Official title: Collaboration on Alcohol Self Administration in Adolescents and Young Adults - Specific Aim 2: To Examine the Effect of Acute Alcohol Administration on Forebrain Disinhibition Using Functional Magnetic Resonance Imaging (fMRI)
Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1 ("Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)"; ClinicalTrials.gov identifier: NCT01063166). The functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity related to disinhibition measured with the Stop Signal task will be assessed during a continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at 60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is associated with the initial drinking trajectories and the alcohol consumption at age 18 and at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor Aggression Paradigm to determine which brain areas mediate increased physical aggression during the same continuous infusion of alcohol as described above. All participants will undergo an alcohol and a placebo fMRI session.
- Conditions
- Alcoholism
- Being tested
- Ethanol, Placebo - half-normal saline
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
Intravenous infusion of 6% ethanol in half-normal saline for approximately 1 hour: The dosage is controlled by a physiologically-based pharmacokinetic (PBPK) model of alcohol distribution and elimination, developed by O'Connor and his associates at the Indiana Alcohol Research Center (IARC) (Ramchandani et al, 1999). PBPK Parameters that determine the dosage and frequency of the infusion for a specific individual are estimated by means of morphometric variables (age, height, weight and gender).
Placebo - half-normal salineDrug
Intravenous infusion of half-normal saline for approximately 1 hour: The dosage is equal to the infusion dosage estimated by the PBPK model of alcohol distribution and elimination (Ramchandani et al., 1999) for the drug - ethanol condition.
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.
Measured: 2 years
Secondary outcomes (5)
Absolute perfusion levels assessed with arterial spin labeling
Measured: 1 week
Behavioural Stop Signal Reaction Time (SSRT)
Measured: 1 week
BOLD fMRI correlate of aggression
Measured: 1 week
Taylor aggression score
Measured: 1 week
BOLD fMRI correlate of disinhibition
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionApr 2012
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Michael N. Smolka, Prof. Dr., Principal investigator, Technische Universitaet Dresden - - Faculty of Medicine Carl Gustav Carus - Department of Psychiatry and PsychotherapyUlrich S. Zimmermann, Dr., Principal investigator, Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097213
- Sponsor's protocol ID
- U01 AA017900 SA2
- Other IDs
- U01AA017900
- Status last verified
- Mar 2013
- First submitted
- 11 Mar 2010
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gan G, Guevara A, Marxen M, Neumann M, Junger E, Kobiella A, Mennigen E, Pilhatsch M, Schwarz D, Zimmermann US, Smolka MN. Alcohol-induced impairment of inhibitory control is linked to attenuated brain responses in right fronto-temporal cortex. Biol Psychiatry. 2014 Nov 1;76(9):698-707. doi: 10.1016/j.biopsych.2013.12.017. Epub 2014 Jan 15.
PubMed 24560581
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. 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 2: To Examine the Effect of Acute Alcohol Administration on Forebrain Disinhibition Using Functional Magnetic Resonance Imaging (fMRI)
- ClinicalTrials.gov ID
- NCT01097213
- Acronym / sponsor ID
- U01 AA017900 SA2
- Conditions
- Alcoholism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Apr 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.
Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1 ("Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)"; ClinicalTrials.gov identifier: NCT01063166). The functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity related to disinhibition measured with the Stop Signal task will be assessed during a continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at 60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is associated with the initial drinking trajectories and the alcohol consumption at age 18 and at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor Aggression Paradigm to determine which brain areas mediate increased physical aggression during the same continuous infusion of alcohol as described above. All participants will undergo an alcohol and a placebo fMRI 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)
- male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
- written informed consent by the subject;
- habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
- at least one prior experience of alcohol intoxication
- being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
Key exclusion criteria (12 listed)
- prior medical treatment due to alcohol use;
- current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
- current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
- current or prior history of alcohol-induced flushing reactions;
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolIntravenous infusion of 6% ethanol in half-normal saline for approximately 1 hour: The dosage is controlled by a physiologically-based pharmacokinetic (PBPK) model of alcohol distribution and elimination, developed by O'Connor and his associates at the Indiana Alcohol Research Center (IARC) (Ramchandani et al, 1999). PBPK Parameters that determine the dosage and frequency of the infusion for a specific individual are estimated by means of morphometric variables (age, height, weight and gender). | Drug | – |
| Placebo - half-normal salineIntravenous infusion of half-normal saline for approximately 1 hour: The dosage is equal to the infusion dosage estimated by the PBPK model of alcohol distribution and elimination (Ramchandani et al., 1999) for the drug - ethanol condition. | Drug | – |
Primary outcome
Alcohol consumption
Time frame: 2 years
Alcohol consumption, as measured by a Timeline Followback Interview.
5 secondary outcomes
Absolute perfusion levels assessed with arterial spin labeling
Time frame: 1 week
Behavioural Stop Signal Reaction Time (SSRT)
Time frame: 1 week
BOLD fMRI correlate of aggression
Time frame: 1 week
Taylor aggression score
Time frame: 1 week
BOLD fMRI correlate of disinhibition
Time frame: 1 week
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 12 Mar 2013.
- Derived from this study: PubMed 24560581Gan G, Guevara A, Marxen M, Neumann M, Junger E, Kobiella A, Mennigen E, Pilhatsch M, Schwarz D, Zimmermann US, Smolka MN. Alcohol-induced impairment of inhibitory control is linked to attenuated brain responses in right fronto-temporal cortex. Biol Psychiatry. 2014 Nov 1;76(9):698-707. doi: 10.1016/j.biopsych.2013.12.017. Epub 2014 Jan 15.
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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.
Michael N. Smolka, Prof. Dr. principal investigator
Technische Universitaet Dresden - - Faculty of Medicine Carl Gustav Carus - Department of Psychiatry and Psychotherapy
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 12 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 12 Mar 2013. 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 NCT01097213, 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 12 Mar 2013.