Smoking, Smoking Cessation, Smoking, Cigarette, Smoking, Tobacco
Conditions
Brief summary
The purpose of this study is to learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not. Smoking use causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit. Varenicline (sometimes called Chantix), is a prescription medication approved by the US FDA. Many studies show that use of varenicline can help smokers quit smoking. Varenicline is a prescription medication, which usually means that people have to see a doctor to get it. This study examines a different way to deliver varenicline, delivered directly to participants for a few weeks, and without need to see a doctor. This method is called varenicline sampling. The study is sponsored by the Hollings Cancer Center at the Medical University of South Carolina. The study is being done at the Medical University of South Carolina, but study recruitment is based state-wide, throughout South Carolina.
Interventions
varenicline comes in bottles of 56 - 0.5 mg pills
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized into one of the two study groups, like drawing numbers from a hat. One group will receive a mailed sample of varenicline, and the other will not. Participants have 50/50 chance of being in either group. Both groups will contain equal numbers of smokers motivated to quit and smokers not currently motivated to quit.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18+ * daily smoker (25+ days/previous month) * smoking 5+ cigarettes/day; * smoking \> 1yr; * some interest in eventual quitting (\>2 on 10-point scale); * has a primary care doctor and has seen that doctor at least once in past year; and * own a smartphone or have regular (daily) access/use of email.
Exclusion criteria
* reports of history of seizures or seizure disorders; * suicidal ideation in past month; * any lifetime suicide attempt; * currently pregnant, breastfeeding, or planning to become pregnant; or * reports of hallucinations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Attempts | From study enrollment through end of three-month follow up | Percent of participants with any self-defined and any self-defined 24-hr quit attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion of Varenicline Use | At the end of the three-month follow up | Percent of participants in the sampling group using varenicline at 3-month follow up assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Group 50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.
Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills | 50 |
| Control Group 50 participants will be enrolled in this group. | 49 |
| Total | 99 |
Baseline characteristics
| Characteristic | Control Group | Total | Varenicline Group |
|---|---|---|---|
| Age, Continuous | 40.4 Years STANDARD_DEVIATION 11.5 | 41.7 Years STANDARD_DEVIATION 12.1 | 43.0 Years STANDARD_DEVIATION 12.8 |
| Baseline Cigarettes Per Day (7 day avg) | 15.1 cigarettes per day STANDARD_DEVIATION 7.3 | 16.8 cigarettes per day STANDARD_DEVIATION 7.3 | 18.4 cigarettes per day STANDARD_DEVIATION 7.2 |
| Cigarette Dependence (Heaviness of Smoking Index) | 2.8 units on a scale STANDARD_DEVIATION 1.5 | 3.1 units on a scale STANDARD_DEVIATION 1.4 | 3.4 units on a scale STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 10 Participants | 18 Participants | 8 Participants |
| Race/Ethnicity, Customized Multiracial | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 75 Participants | 40 Participants |
| Region of Enrollment United States | 49 participants | 99 participants | 50 participants |
| Sex: Female, Male Female | 35 Participants | 57 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 42 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 26 / 50 | 10 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
Quit Attempts
Percent of participants with any self-defined and any self-defined 24-hr quit attempt
Time frame: From study enrollment through end of three-month follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varenicline Group | Quit Attempts | Any self defined quit attempt | 30 Participants |
| Varenicline Group | Quit Attempts | Any 24 hour quit attempt | 26 Participants |
| Control Group | Quit Attempts | Any self defined quit attempt | 24 Participants |
| Control Group | Quit Attempts | Any 24 hour quit attempt | 17 Participants |
Secondary
Conversion of Varenicline Use
Percent of participants in the sampling group using varenicline at 3-month follow up assessment.
Time frame: At the end of the three-month follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varenicline Group | Conversion of Varenicline Use | Any use of varenicline | 12 Participants |
| Varenicline Group | Conversion of Varenicline Use | Daily use of varenicline | 5 Participants |