Smoking Cessation
Conditions
Keywords
smoking cessation, varenicline, smoking cessation treatment
Brief summary
The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.
Detailed description
This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.
Interventions
DRUGvarenicline
variable dosing schedule
DRUGplacebo
placebo
Sponsors
Pfizer
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* currently smoking at least 15 cigarettes daily * in good health * able to read and speak English fluently * have a home telephone and plan to reside in Western New York for 6 months * willing to make quit attempt * signed informed consent * who planned quit attempt.
Exclusion criteria
* serious medical condition * depression or mental health condition requiring treatment in the past year * history of panic disorder, psychosis, bipolar disorder * alcohol or drug abuse in the past year * use of tobacco products other than cigarettes * current use of other cessation pharmacotherapies * pregnancy/planned pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Smoking Behavior | Change in cigarettes per day from Week 2 to Week 5 | Change in cigarettes per day from Week 2 to Week 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Smoking Cessation. | 12 weeks after quit date. | To parallel most clinical trials of varenicline, we focused on CO-verified (\<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extended Run-In The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment. | 32 |
| Standard Run-In The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.
Both groups received brief cognitive-behavioral counseling. | 28 |
| Total | 60 |
Baseline characteristics
| Characteristic | Extended Run-In | Standard Run-In | Total |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 10 | 49 years STANDARD_DEVIATION 10 | 48 years STANDARD_DEVIATION 9 |
| Baseline CPD | 21 Cigarettes Per Day STANDARD_DEVIATION 5 | 21 Cigarettes Per Day STANDARD_DEVIATION 5 | 21 Cigarettes Per Day STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Nonwhite | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 29 Participants | 23 Participants | 52 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 28 |
| other Total, other adverse events | 18 / 32 | 6 / 28 |
| serious Total, serious adverse events | 0 / 32 | 1 / 28 |
Outcome results
Primary
Change in Smoking Behavior
Change in cigarettes per day from Week 2 to Week 5
Time frame: Change in cigarettes per day from Week 2 to Week 5
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Run-In | Change in Smoking Behavior | -6.3 Change in Cigarettes Per Day | Standard Error 0.9 |
| Standard Run-In | Change in Smoking Behavior | -3.2 Change in Cigarettes Per Day | Standard Error 0.7 |
Secondary
Rates of Smoking Cessation.
To parallel most clinical trials of varenicline, we focused on CO-verified (\<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.
Time frame: 12 weeks after quit date.
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Run-In | Rates of Smoking Cessation. | 17 Participants |
| Standard Run-In | Rates of Smoking Cessation. | 11 Participants |