Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00616746
• Collaborator: VA Connecticut Healthcare System (U.S. Fed)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 41
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• 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: Jan 1, 2007
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Behavioral and Cognitive Measures [Baseline and Test Day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or Female, 21 to 50 years old.

Exclusion Criteria:

• Alcohol or Nicotine Naive

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00616746
• Other Study ID Numbers: 0607001614
• First Posted: Feb 15, 2008
• Last Update Posted: Jul 8, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Yale University: Alcohol, nicotine
• Additional relevant MeSH terms: Alcohol Drinking; Ethanol; Nicotine

Study Results

No Results Posted as of Jul 8, 2014