Varenicline and Nicotine Interactions in Humans (VA)

Smoking Cessation Clinical Trial

Official title:

Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606892
• Other study ID #: HIC # 0702002338
• Secondary ID: MIRECC 000000000
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: September 9, 2014
• Start date: August 2007
• Est. completion date: November 2009

Study information

• Verified date: September 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Varenicline
Varenicline (1 mg per day) given for 4 days prior to laboratory session
• Placebo
Sugar Pill
• 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.

Locations

Country	Name	City	State
United States	Veterans Affairs Hospital	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sofuoglu M, Herman AI, Mooney M, Waters AJ. Varenicline attenuates some of the subjective and physiological effects of intravenous nicotine in humans. Psychopharmacology (Berl). 2009 Nov;207(1):153-62. doi: 10.1007/s00213-009-1643-z. Epub 2009 Aug 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Responses to Intravenous Nicotine	The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.	30 minutes after each nicotine infusion	No
Secondary	Mean Reaction Time (RT) on Modified Stroop Task.	A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).	pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)	No
Secondary	Cotinine Levels	Subject Cotinine Levels before each laboratory session.	Before each laboratory session on day 5	No
Secondary	Heart Rate	The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.	30 minutes after each nicotine infusion	Yes
Secondary	Changes in Systolic and Diastolic Blood Pressure	The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.	30 minutes after each nicotine infusion	Yes