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Neural Mechanisms Underlying Alcohol Induced Disinhibition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01097213
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : March 12, 2013
Indiana University School of Medicine
Information provided by (Responsible Party):
Technische Universität Dresden

Brief 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)"; 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.

Condition or disease Intervention/treatment
Alcoholism Drug: Ethanol Drug: Placebo - half-normal saline

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : December 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Ethanol
    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).
  • Drug: Placebo - half-normal saline
    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.

Primary Outcome Measures :
  1. Alcohol consumption [ Time Frame: 2 years ]
    Alcohol consumption, as measured by a Timeline Followback Interview.

Secondary Outcome Measures :
  1. Absolute perfusion levels assessed with arterial spin labeling [ Time Frame: 1 week ]
  2. Behavioural Stop Signal Reaction Time (SSRT) [ Time Frame: 1 week ]
  3. BOLD fMRI correlate of aggression [ Time Frame: 1 week ]
  4. Taylor aggression score [ Time Frame: 1 week ]
  5. BOLD fMRI correlate of disinhibition [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 19 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Residents living within 15 km (9.5 miles) from downtown Dresden

Inclusion Criteria:

  • 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;
  • 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

Exclusion Criteria:

  • 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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01097213

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Technische Universitaet Dresden - Dresden fMRT-Neuroimaging Center
Dresden, Saxony, Germany, 01187
Sponsors and Collaborators
Technische Universität Dresden
Indiana University School of Medicine
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Principal Investigator: Michael N. Smolka, Prof. Dr. Technische Universitaet Dresden - - Faculty of Medicine Carl Gustav Carus - Department of Psychiatry and Psychotherapy
Principal Investigator: Ulrich S. Zimmermann, Dr. Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Technische Universität Dresden Identifier: NCT01097213    
Other Study ID Numbers: U01 AA017900 SA2
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs