Smoking Cessation
Conditions
Brief summary
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
Interventions
DRUGvarenicline tartrate (CP-526, 555-18)
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
DRUGPlacebo
matching placebo 1 tablet twice a day for 12 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Current male or female cigarette smokers who are motivated to stop smoking. * Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.
Exclusion criteria
* Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months. * Patients currently with depression or diagnosed with depression in past 12 months. * Past or present history of psychosis, panic disorder, or bipolar disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 4-week Continuous Abstinence | Weeks 9 through 12 | The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Continuous Abstinence | Weeks 9 through 24 | The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO \> 10 ppm |
| Number of Participants With Seven-day Point Prevalence of Abstinence | Week 12 and 24 | Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO \>10 ppm on that day |
Countries
Brazil, Colombia, Costa Rica, Egypt, Jordan, Lebanon, Mexico, Saudi Arabia, South Africa, United Arab Emirates, Venezuela
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline 0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks | 390 |
| Placebo matching placebo following the same treatment schema as the varenicline group | 198 |
| Total | 588 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 3 |
| Overall Study | Lack of Efficacy | 3 | 4 |
| Overall Study | Lost to Follow-up | 9 | 5 |
| Overall Study | Other | 4 | 3 |
| Overall Study | Randomized but not treated | 4 | 1 |
| Overall Study | Withdrawal by Subject | 23 | 29 |
Baseline characteristics
| Characteristic | Varenicline | Placebo | Total |
|---|---|---|---|
| Age, Customized < 55 | 334 years | 164 years | 498 years |
| Age, Customized 55 - 65 | 49 years | 28 years | 77 years |
| Age, Customized > 65 | 7 years | 6 years | 13 years |
| Sex: Female, Male Female | 165 Participants | 68 Participants | 233 Participants |
| Sex: Female, Male Male | 225 Participants | 130 Participants | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 224 / 390 | 82 / 198 |
| serious Total, serious adverse events | 11 / 390 | 2 / 198 |
Outcome results
Primary
Number of Participants With 4-week Continuous Abstinence
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits
Time frame: Weeks 9 through 12
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Participants With 4-week Continuous Abstinence | 209 participants |
| Placebo | Number of Participants With 4-week Continuous Abstinence | 37 participants |
p-value: <0.000195% CI: [3.74, 8.88]Regression, Logistic
Secondary
Number of Participants With Continuous Abstinence
The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO \> 10 ppm
Time frame: Weeks 9 through 24
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Participants With Continuous Abstinence | 155 participants |
| Placebo | Number of Participants With Continuous Abstinence | 26 participants |
p-value: <0.000195% CI: [2.97, 7.68]Regression, Logistic
Secondary
Number of Participants With Seven-day Point Prevalence of Abstinence
Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO \>10 ppm on that day
Time frame: Week 12 and 24
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Seven-day Point Prevalence of Abstinence | Week 12 | 220 participants |
| Varenicline | Number of Participants With Seven-day Point Prevalence of Abstinence | Week 24 | 185 participants |
| Placebo | Number of Participants With Seven-day Point Prevalence of Abstinence | Week 12 | 45 participants |
| Placebo | Number of Participants With Seven-day Point Prevalence of Abstinence | Week 24 | 38 participants |
Comparison: Week 12p-value: <0.000195% CI: [3.3, 7.5]Regression, Logistic
Comparison: Week 24p-value: <0.000195% CI: [2.8, 6.5]Regression, Logistic