Varenicline and Nicotine Interactions in Humans (VA)

Yale University

Status: Completed

Conditions: Smoking Cessation

Treatments: Drug: Placebo; Drug: IV Nic; Drug: Varenicline

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00606892

R01DA014537 (U.S. NIH Grant/Contract)

HIC # 0702002338

MIRECC 000000000 (Registry Identifier)

DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 2 patient groups

Placebo First, varenicline, + IV Nic

Experimental group

Description:

Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg).

Treatment:

Drug: Varenicline

Drug: IV Nic

Drug: Placebo

Varenicline first, placebo, + IV Nic

Experimental group

Description:

Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg).

Treatment:

Drug: Varenicline

Drug: IV Nic

Drug: Placebo