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Varenicline and Nicotine Interactions in Humans (VA)

NCT00606892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-09-25

Study results available
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Summary

To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.

Conditions

  • Smoking Cessation

Interventions

DRUG

Varenicline

Varenicline (1 mg per day) given for 4 days prior to laboratory session

DRUG

Placebo

Sugar Pill

DRUG

IV Nic

IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.

Sponsors & Collaborators

Principal Investigators

  • Mehmet Sofuoglu, M.D., Ph.D. · Yale University Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00606892 on ClinicalTrials.gov