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Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

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ClinicalTrials.gov Identifier: NCT00616746
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Tobacco Use Drug: Nicotine Drug: Ethanol Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans
Study Start Date : January 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Three test days, within-subject design.
Drug: Nicotine
1.0 microg/kg/min IV x 10 minutes
Drug: Ethanol
IV



Primary Outcome Measures :
  1. Behavioral and Cognitive Measures [ Time Frame: Baseline and Test Day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female, 21 to 50 years old.

Exclusion Criteria:

  • Alcohol or Nicotine Naive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616746


Locations
United States, Connecticut
VA Connecticut Healthcare System, West Haven Campus
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
Investigators
Principal Investigator: Deepak C D'Souza, M.D. Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00616746     History of Changes
Other Study ID Numbers: 0607001614
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Yale University:
Alcohol, nicotine

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Nicotine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action