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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

Page last updated: August 23, 2015

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