Varenicline and Nicotine Interactions in Humans (VA)
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking Cessation
Intervention: Varenicline (Drug); Placebo (Drug); IV Nic (Drug)
Phase: N/A
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s): Mehmet Sofuoglu, M.D., Ph.D., Principal Investigator, Affiliation: Yale University Associate Professor
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.
Clinical Details
Official title: Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Subjective Responses to Intravenous Nicotine
Secondary outcome: Mean Reaction Time (RT) on Modified Stroop Task.Cotinine Levels Heart Rate Changes in Systolic and Diastolic Blood Pressure
Detailed description:
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female
smokers will have two 4-day treatment periods, in which they will be randomized to
varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers
will have daily clinic visits and receive their study medication. On Day 4, subjects will
come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine
(0. 1, 0. 4, and 0. 7 mg per 70kg). This procedure will allow accurate assessment of
varenicline effects on the subjective, physiological and cognitive responses to nicotine.
Following a washout period, subjects will be crossed over to the alternative treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Female and male smokers, aged 18 to 55 years
- History of smoking daily for the past 12 months, at least 15 cigarettes daily
- Carbon Monoxide (Alveolar) level > 10ppm
- For women: not pregnant as determined by pregnancy screening, nor breast feeding, and
using acceptable birth control methods
Exclusion Criteria:
- History of heart disease, renal or hepatic diseases
- other medical conditions that the physician investigator deems as contraindicated for
the subject to be in the study
- Regular use of psychotropic medication (antidepressants, antipsychotics, or
anxiolytics)
- recent psychiatric diagnosis and treatment for Axis I disorders including
- major depression, bipolar affective disorder,
- schizophrenia and panic disorder within the past year
- Current dependence on alcohol
- drugs or treatments for drug
- alcohol addiction within the past 5 years
- Allergy to varenicline
Locations and Contacts
Veterans Affairs Hospital, West Haven, Connecticut 06516, United States
Additional Information
Starting date: August 2007
Last updated: September 9, 2014
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