Measuring Smoking Behaviors While Using Varenicline

NCT ID: NCT00948155

Last Updated: 2014-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-11-30

Brief Summary

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

Detailed Description

This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.

Conditions

Nicotine Dependence

Keywords

smoking; nicotine; varenicline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Varenicline before placebo

Drug (Varenicline (Chantix)): Placebo

Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Placebo then Varenicline

Placebo: Drug Varenicline (Chantix)

Intervention to be administered is: participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Intervention 'Drug (Varenicline (Chantix)): Placebo'

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Interventions

Varenicline

Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Intervention Type: DRUG

Other Intervention Names

Chantix

Eligibility Criteria

Inclusion Criteria

• self report minimum 10 daily cigarettes
• self report smoking every day past 5 years
• between the ages 21-65
• self report intention to try to quit smoking in the next 6 months

Exclusion Criteria

• self reported use of any nicotine-containing products other than non-menthol cigarettes
• self reported history or current treatment of substance abuse (other than nicotine dependence)
• self reported alcohol use greater than 25 standard drinks per week;
• currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
• self reported history or current diagnosis of any Axis 1 disorders except past depression
• self reported serious or unstable disease within past year
• self reported history of epilepsy or seizure disorder;
• self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
• self reported kidney function impairment
• any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
• less than 5 years of daily smoking
• any medical condition or concomitant medication that could compromise participant safety or treatment
• provide a baseline carbon monoxide (CO) reading < 10 ppm
• self reported use of non filtered cigarettes
• inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Andrew Strasser

Associate Professor Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Strasser, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Tobacco Use Research Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

Ashare RL, Tang KZ, Mesaros AC, Blair IA, Leone F, Strasser AA. Effects of 21 days of varenicline versus placebo on smoking behaviors and urges among non-treatment seeking smokers. J Psychopharmacol. 2012 Oct;26(10):1383-90. doi: 10.1177/0269881112449397. Epub 2012 Jun 13.

Reference Type: RESULT

PMID: 22695488 (View on PubMed)

Other Identifiers

808930

Identifier Type: -

Identifier Source: org_study_id