Tobacco Use Disorder
Conditions
Brief summary
This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking
Detailed description
PRIMARY OBJECTIVES: I. To determine if mail delivery of 12 weeks of varenicline results in improved smoking cessation outcomes relative to nicotine replacement therapy (NRT) in 300 smokers. II. To determine if delivery of varenicline is cost-effective as compared to nicotine patch. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28. Courses repeat every 28 days for up to 12 weeks. ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks. After completion of study treatment, patients are followed up at 4 months.
Interventions
DRUGvarenicline
Given PO
DRUGnicotine patch
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking * State that they are under the care of a primary care physician * Are eligible for receipt of pharmacotherapy by mail using the standard NRT criteria * Speak English * Answer no to the following 3 questions: * Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder? * Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself? * Is there any reason that you cannot use varenicline/Chantix?
Exclusion criteria
* State that they are not under the care of a primary care physician * Are not eligible for receipt of pharmacotherapy by mail using the standard NRT criteria * Do not speak English * Answer yes to the question, have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder? * Answer yes to the question, have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself? * Answer yes to the question, is there any reason that you cannot use varenicline/Chantix? * Are women who are currently pregnant * Report that they are unwilling to receive or take varenicline on screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Rate | 4 months | The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Varenicline) Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.
varenicline: Given PO | 200 |
| Arm II (Nicotine Patch) Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.
nicotine patch | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | Total | Arm II (Nicotine Patch) | Arm I (Varenicline) |
|---|---|---|---|
| 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 | 300 Participants | 100 Participants | 200 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 13 | 46.1 years STANDARD_DEVIATION 13.8 | 47.2 years STANDARD_DEVIATION 13.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 13 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 266 Participants | 87 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 62 Participants | 16 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 238 Participants | 84 Participants | 154 Participants |
| Region of Enrollment United States | 300 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 140 Participants | 47 Participants | 93 Participants |
| Sex: Female, Male Male | 160 Participants | 53 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 100 |
| other Total, other adverse events | 0 / 200 | 0 / 100 |
| serious Total, serious adverse events | 0 / 200 | 0 / 100 |
Outcome results
Primary
Quit Rate
The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval.
Time frame: 4 months
Population: self reported abstinence
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Varenicline) | Quit Rate | 13 Participants |
| Arm II (Nicotine Patch) | Quit Rate | 23 Participants |