Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

This study has been completed.
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00616746
First received: February 4, 2008
Last updated: July 7, 2014
Last verified: July 2014
  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 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Yale University
ClinicalTrials.gov 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
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014