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Sponsors and Collaborators: |
Yale University VA Connecticut Healthcare System |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00616746 |
The purpose of this study is to characterize the interactive psychopharmacologic effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol. The IV alcohol administration will be accomplished using the breath alcohol (BrAc) clamp method.
The primary hypothesis is that nicotine will attenuate the disruptive effects of alcohol on cognitive inhibition as measured by the Continuous Performance Task-Identical Pairs (CPT-IP) task, processing speed and attention as measured by the CPT-IP, and working memory as measured by the Rey Auditory Verbal Learning Task.
The secondary, exploratory hypothesis is that nicotine will attenuate the disruptive effects of alcohol on impulse control (risky decision-making) as measured by the Balloon Analog Risk Task. We also hypothesize that administration of nicotine will decrease alcohol-induced inhibitory effects as measured by the Visual Analog Scales of Mood States and the Biphasic Alcohol Effects Scale, and that alcohol will increase nicotine craving and withdrawal as measured by the QSU-Brief.
Condition | Intervention |
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Alcohol Consumption Tobbaco Use |
Drug: Nicotine Drug: Ethanol |
Study Type: | Interventional |
Study Design: | Double Blind (Subject, Investigator, Outcomes Assessor), Single Group Assignment |
Official Title: | Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans |
Estimated Enrollment: | 34 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Three test days, within-subject design.
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Drug: Nicotine
1.0 microg/kg/min IV x 10 minutes
Drug: Ethanol
IV
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Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vanessa Bufis | 203-932-5711 ext 2526 | vanessa.bufis@yale.edu |
United States, Connecticut | |
VA Connecticut Healthcare System, West Haven Campus | Recruiting |
West Haven, Connecticut, United States, 06516 | |
Principal Investigator: Edward B Perry, M.D. |
Principal Investigator: | Edward B Perry, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Edward Perry, M.D. ) |
Study ID Numbers: | 0607001614 |
Study First Received: | February 4, 2008 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00616746 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Alcohol, nicotine |
Nicotine polacrilex Neurotransmitter Agents Nicotine Nicotinic Agonists Drinking Behavior |
Central Nervous System Stimulants Peripheral Nervous System Agents Cholinergic Agents Alcohol Drinking Ethanol |
Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Physiological Effects of Drugs Drinking Behavior Central Nervous System Stimulants Alcohol Drinking |
Cholinergic Agents Pharmacologic Actions Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |