Neural Mechanisms Underlying Alcohol Induced Disinhibition

NCT ID: NCT01097213

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-04-30

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)"; 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael N. Smolka, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Technische Universitaet Dresden - - Faculty of Medicine Carl Gustav Carus - Department of Psychiatry and Psychotherapy

Ulrich S. Zimmermann, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Locations

Technische Universitaet Dresden - Dresden fMRT-Neuroimaging Center

Dresden, Saxony, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 24560581 (View on PubMed)

Other Identifiers

U01AA017900

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01 AA017900 SA2

Identifier Type: -

Identifier Source: org_study_id