Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

Verified by: Yale University, July 2011
First Received: February 4, 2008 | Last Updated: July 26, 2011 | Phase: N/A | Start Date: January 2007
Overall Status: Active, not recruiting | Estimated Enrollment: 34
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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...

Brief Summary

Official Title: “Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans”

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.

  • Study Type: Interventional
  • Study Design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

  • Drug: Nicotine
    • 1.0 microg/kg/min IV x 10 minutes
  • Drug: Ethanol
    • IV

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Three test days, within-subject design.

Outcome Measures for this Clinical Trial

Primary Measures

  • Behavioral and Cognitive Measures
    • Time Frame: Baseline and Test Day
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male or Female, 21 to 50 years old.

Exclusion Criteria:

  • Alcohol or Nicotine Naive

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Yale University Other

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00616746

Study ID Number: 0607001614

ClinicalTrials.gov Identifier: NCT00616746

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00616746