Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

This study has been completed.
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Yale University Identifier:
First received: February 4, 2008
Last updated: July 7, 2014
Last verified: July 2014
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 Intervention Phase
Alcohol Consumption
Tobacco Use
Drug: Nicotine
Drug: Ethanol
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Behavioral and Cognitive Measures [ Time Frame: Baseline and Test Day ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: January 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Three test days, within-subject design.
Drug: Nicotine
1.0 microg/kg/min IV x 10 minutes
Drug: Ethanol


Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or Female, 21 to 50 years old.

Exclusion Criteria:

  • Alcohol or Nicotine Naive
  Contacts and Locations
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Please refer to this study by its identifier: NCT00616746

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
Principal Investigator: Deepak C D'Souza, M.D. Yale University
  More Information

Responsible Party: Yale University Identifier: NCT00616746     History of Changes
Other Study ID Numbers: 0607001614 
Study First Received: February 4, 2008
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Alcohol, nicotine

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 30, 2016