Measuring Smoking Behaviors While Using Varenicline

NCT00948155 | Completed Phase 4 Results DMC

• 1 other identifier: 808930
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

smoking; nicotine; varenicline

Outcome Measures

Primary Outcomes (3)

• Smoking Topography: Total Puff Volume

  Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.

  Days 1-21 of each of 2 study periods

• The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.

  Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.

  Days 1, 7, 21 of each of two 21 day study periods

• Daily Cigarette Consumption

  Average of the number of cigarettes smoked per day

  Two 21 day study periods

Secondary Outcomes (5)

• Total Nicotine Metabolites From Urine Samples

  Samples from Day 1 and Day 21 of two 21 day Periods

• Nicotine Levels From Urine Samples

  Samples from Day 1 and Day 21 of two 21 day Periods

• Cotinine Levels From Urine Samples

  Samples from Day 1 and Day 21 of two 21 day Periods

• Carbon Monoxide Levels

  Samples from Day 1 and Day 21 of two 21 day Periods

• Subjective Measures to Assess Smoking Urges

  Days 21 of each of the two 21-day study periods, range 1(low)-7(high)

Study Arms (2)

Varenicline before placebo

EXPERIMENTAL

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.

Drug: Varenicline

Placebo then Varenicline

EXPERIMENTAL

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'

Drug: Varenicline

Interventions

Varenicline 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.

Also known as: Chantix

Placebo then Varenicline; Varenicline before placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pfizer: collaborator

Study Sites (1)

Tobacco Use Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 22695488 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Attrition rates were high. The final sample consisted primarily of Caucasian males, which may limit the generalizability of the present findings.

Results Point of Contact

• Title: Andrew A. Strasser, Ph.D., Associate Professor
• Organization: University of Pennsylvania

strasse3@mail.med.upenn.edu

215 746 5788

Study Officials

• Andrew Strasser, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Psychiatry

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 16, 2014
• Results First Posted: December 16, 2014

Record last verified: 2014-12

Locations

US (1)