Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

NCT ID: NCT00616746

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Consumption Tobacco Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Three test days, within-subject design.

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

1.0 microg/kg/min IV x 10 minutes

Ethanol

Intervention Type DRUG

IV

Interventions

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Nicotine

1.0 microg/kg/min IV x 10 minutes

Intervention Type DRUG

Ethanol

IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or Female, 21 to 50 years old.

Exclusion Criteria

* Alcohol or Nicotine Naive
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Connecticut Healthcare System

FED

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deepak C D'Souza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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VA Connecticut Healthcare System, West Haven Campus

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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0607001614

Identifier Type: -

Identifier Source: org_study_id

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