Neural Mechanisms Underlying Alcohol Induced Disinhibition

This study has been completed.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01097213
First received: March 11, 2010
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Alcoholism
Drug: Ethanol
Drug: Placebo - half-normal saline

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Alcohol consumption [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Alcohol consumption, as measured by a Timeline Followback Interview.


Secondary Outcome Measures:
  • Absolute perfusion levels assessed with arterial spin labeling [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Behavioural Stop Signal Reaction Time (SSRT) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • BOLD fMRI correlate of aggression [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Taylor aggression score [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • BOLD fMRI correlate of disinhibition [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097213

Locations
Germany
Technische Universitaet Dresden - Dresden fMRT-Neuroimaging Center
Dresden, Saxony, Germany, 01187
Sponsors and Collaborators
Technische Universität Dresden
Indiana University School of Medicine
Investigators
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
  More Information

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01097213     History of Changes
Other Study ID Numbers: U01 AA017900 SA2
Study First Received: March 11, 2010
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014