Long-term Varenicline Treatment for Smoking Cessation
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- daily smoker
- 5+ cigarettes per day for at least one year
- expired carbon monoxide level of 5+ ppm
Exclusion criteria
- current use of smoking cessation pharmacotherapies
- current or history of psychotic disorder
- current major depressive disorder
- history of suicidal ideation in the previous 3 months
- unstable medical condition
- pregnant, nursing, or planning to become pregnant
- planning to move from study area within 18 months
Trial design
Primary purpose
Allocation
Interventional model
Masking
101 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal