Phase 4
N=1,493
A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01370356 ↗Enrolled (actual)
1,493
Serious AEs
2.9%
Results posted
Sep 2014
Primary outcome: Primary: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking — 32.1; 6.9 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varenicline Tartrate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking |
32.1; 6.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With CO Confirmed 4-Week CA From Smoking |
37.8; 12.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With CO Confirmed Long Term CA From Smoking |
27.0; 9.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation |
31.2; 6.7; 43.2; 17.5; 34.1; 18.3 | <0.0001 sig |
| SECONDARY Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation |
32.8; 17.3 | <0.0001 sig |
Summary
This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.
Eligibility Criteria
Inclusion Criteria
- Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) >10 ppm at screening.
- Subjects with mild to moderate depression or anxiety may be included if their condition is stable.
Exclusion Criteria
- Subjects with a history of a suicide attempt or any suicidal behavior in the past two years.
- Subjects with severe depression or anxiety.
- Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
- Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.
Data sourced from ClinicalTrials.gov (NCT01370356). 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.