Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Yale University |
---|---|
Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00588952 |
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: Ketamine Drug: Thiopental Drug: Placebo |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | NMDA Dysregulation in Individuals With a Family Vulnerability to Alcoholism |
Estimated Enrollment: | 60 |
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 |
---|---|
Ketamine: Active Comparator
0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Ketamine
|
Drug: Ketamine
Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV
|
Thiopental: Active Comparator
1.5 mg/kg, loading dose and an infusion rate of 40 mcg/kg/minute for 60 minutes, IV Thiopental
|
Drug: Thiopental
Thiopental: 1.5 mg/kg, loading dose and an infusion rate of 40 mcg/kg/minute for 60 minutes
|
Placebo: Placebo Comparator
loading dose and an infusion for 60 minutes saline solution (Placebo)
|
Drug: Placebo
Placebo: loading dose and an infusion for 60 minutes saline solution
|
Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to decrease 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 ketamine 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 the 60-minute intravenous infusion of placebo, ketamine, thiopental. Outcome measures include the Positive and Negative Symptom Scale and the Clinician-Administered Dissociative States Scale to measure perceptual responses to ketamine, and visual analog scales for mood states. Secondary measures include visual analog scales for high, similarity to ethanol, the Sensation Scale (a validated measure of ethanol-like sensations) and aspects of craving for alcohol.
Ages Eligible for Study: | 21 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diana D. Limoncelli, BA | 203-932-5711 ext 5217 | arc1@yale.edu |
United States, Connecticut | |
VA Connecticut Healthcare System | Recruiting |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Ismene L. Petrakis, MD | Yale University |
Responsible Party: | Yale University ( Ismene Petrakis ) |
Study ID Numbers: | 0103012310, 2P50-AA012870-07 NIAAA |
Study First Received: | December 27, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00588952 |
Health Authority: | United States: Institutional Review Board |
Excitatory Amino Acids Mental Disorders Thiopental Alcoholism Ketamine |
Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders N-Methylaspartate |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Anesthetics, Dissociative Pharmacologic Actions |
Sensory System Agents Anesthetics, General Therapeutic Uses Hypnotics and Sedatives GABA Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |