Text Size

Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00616746
First received: February 4, 2008
Last updated: July 26, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Alcohol Consumption
Tobacco Use
 Drug: Nicotine
Drug: Ethanol

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:

MedlinePlus related topics: Alcohol
U.S. FDA Resources

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 ]

Estimated Enrollment: 34
Study Start Date: January 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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
IV

  Eligibility

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

Inclusion Criteria:

  • Male or Female, 21 to 50 years old.

Exclusion Criteria:

  • Alcohol or Nicotine Naive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Deepak Cyril D'Souza, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00616746     History of Changes
Other Study ID Numbers: 0607001614
Study First Received: February 4, 2008
Last Updated: July 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Alcohol, nicotine

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013