Phase 4
N=29
Measuring Smoking Behaviors While Using Varenicline
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00948155 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Smoking Topography: Total Puff Volume — 523.4; 684.6 milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varenicline (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Topography: Total Puff Volume |
523.4; 684.6 | — |
| PRIMARY The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette. |
12; 11.5 | — |
| PRIMARY Daily Cigarette Consumption |
16.2; 16.1; 14.4; 12.8 | — |
| SECONDARY Total Nicotine Metabolites From Urine Samples |
110; 111; 79; 81 | — |
| SECONDARY Nicotine Levels From Urine Samples |
20.0; 24.0; 18.0; 13.8 | — |
| SECONDARY Cotinine Levels From Urine Samples |
19.0; 16.9; 12.0; 14.0 | — |
| SECONDARY Carbon Monoxide Levels |
30; 23.2; 25; 22 | — |
| SECONDARY Subjective Measures to Assess Smoking Urges |
4.2; 4.3; 3.9; 3.7; 2.5; 2.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00948155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.