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| Sponsor: | Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00612352 |
Purpose
The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an enhanced understanding of the underlying neurobiological mechanism in high risk individuals that may lead to the transition from moderate to excessive use of alcohol.
| Condition | Intervention |
|---|---|
|
Alcoholism |
Drug: 0.1 and 0.04 ethanol doses - IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
| Official Title: | Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2001 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: High Dose Ethanol
Ethanol administered through an IV to 0.1 and clamped for 1 hour.
|
Drug: 0.1 and 0.04 ethanol doses - IV
Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.
|
|
Active Comparator: Low Dose Ethanol
Ethanol administered through an IV to 0.04 and clamped for 1 hour.
|
Drug: 0.1 and 0.04 ethanol doses - IV
Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.
|
|
Placebo Comparator: Placebo
Placebo administered through an IV and clamped for 1 hour.
|
Drug: 0.1 and 0.04 ethanol doses - IV
Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.
|
Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to have decreased dysphoric responses to alcohol self-administration that may promote the excessive use of alcohol. Ethanol has been shown to be an antagonist at the N-methyl-D-aspartate (NMDA) glutamate receptor. We have recently shown that sober alcoholics have decreased dysphoric response to the NMDA antagonist, ketamine. We propose to test the hypothesis that this characteristic exists as a vulnerability factor in those individuals susceptible to develop alcoholism. Specifically, the objective is to determine whether individuals with a family history positive (FHP) for alcoholism will experience less dysphoric, anxiogenic, and psychotogenic effects to alcohol infusion when compared to family history negative (FHN) control subjects.
Male and female subjects, FHP (biological father and one other first degree relative) between the ages of 21-30, and matched controls (FHN) will complete 3 test days in a randomized balanced order under double-blind conditions. Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for over 60 minutes. Outcome measures include the Positive and Negative Symptom Scale, visual analog scales of mood state, (i.e. anxiety) and the Clinician-Administered Dissociative States Scale (CADSS) to measure perceptual responses to alcohol. Secondary measures include visual analog scales for high, similarity to ethanol, Mini Mental Status Examination (MMSE), Placement of electrodes, Biphasic Alcohol Effects Scale, Hopkins Verbal Learning, and number of drinks scale, aspects of craving for alcohol and tests of cognitive impairment.
Eligibility| Ages Eligible for Study: | 21 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For Family History Positive (FHP) Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by FHAM-Family History Assessment Module developed by COGA.
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| VA Connecticut Healthcare System | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Contact: Diana Limoncelli, BA 203-397-7684 ext 5217 arc1@yale.edu | |
| Principal Investigator: | Ismene L Petrakis, MD | Yale University |
More Information
| Responsible Party: | Ismene Petrakis, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00612352 History of Changes |
| Other Study ID Numbers: | 0304025194, 2P50-AA012870-07 NIAAA |
| Study First Received: | December 27, 2007 |
| Last Updated: | January 25, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
