Smoking
Conditions
Keywords
smoking, relapse, withdrawal
Brief summary
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.
Interventions
DRUGvarenicline
Extension of 1 mg twice daily treatment to 52 weeks
BEHAVIORALIndividual smoking cessation counseling
Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits
Sponsors
Pfizer
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 | 7-day point prevalence | Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extended Treatment 52-week varenicline therapy + individual smoking cessation counseling | 50 |
| Standard Treatment 13 weeks of varenicline therapy + individual smoking cessation counseling | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Withdrawal by Subject | 27 | 26 |
Baseline characteristics
| Characteristic | Standard Treatment | Extended Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 50 Participants | 101 Participants |
| Age, Continuous | 43.2 years STANDARD_DEVIATION 12.4 | 42.6 years STANDARD_DEVIATION 11.6 | 42.9 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 51 participants | 50 participants | 101 participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 33 | 12 / 34 |
| serious Total, serious adverse events | 1 / 33 | 1 / 34 |
Outcome results
Primary
Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52
Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52
Time frame: 7-day point prevalence
Population: Participants randomized at 12 weeks who continued in the study to Week 52 and provided CO-verified smoking status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Treatment | Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 | 10 participants |
| Standard Treatment | Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 | 11 participants |