Neural Mechanisms Underlying Alcohol Induced Disinhibition

Alcoholism Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097213
• Other study ID #: U01 AA017900 SA2
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: March 11, 2013
• Start date: December 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics Commission
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 19 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcoholism

Intervention

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).
• 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.

Locations

Country	Name	City	State
Germany	Technische Universitaet Dresden - Dresden fMRT-Neuroimaging Center	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Indiana University School of Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption	Alcohol consumption, as measured by a Timeline Followback Interview.	2 years	No
Secondary	Absolute perfusion levels assessed with arterial spin labeling		1 week	No
Secondary	Behavioural Stop Signal Reaction Time (SSRT)		1 week	No
Secondary	BOLD fMRI correlate of aggression		1 week	No
Secondary	Taylor aggression score		1 week	No
Secondary	BOLD fMRI correlate of disinhibition		1 week	No