Cigarette Smoking
Conditions
Keywords
Smoking, Smoking cessation, Smokeless tobacco, Snus
Brief summary
The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use (snus) can increase the quit rate among cigarette smokers who wish to stop smoking
Detailed description
In a multicenter, double-blind, placebo-controlled setting, participants are randomly allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo product with identical flavoring and physical appearance. The study consists of three phases: Study Product Test Period (4 weeks), Intervention Phase (12 weeks), and a Follow-Up Phase (12 weeks). The participants are all cigarette smokers who are motivated to quit. They are encouraged to gradually substitute as many cigarettes as possible with study products during the Study Product Test Period and to refrain from all cigarettes at the latest by the first day of Week 5. Use of study products will continue during the 12 week Intervention Phase. The participants are encouraged to cut down on use of study products during the last 3 weeks to avoid a too abrupt ending of nicotine intake. All subjects are encouraged to continue in the study for clinical follow-up independent of smoking status although use of study products is discontinued during the Follow-Up Phase. If a subject has managed to quit smoking during the Intervention Phase but there is an imminent danger of smoking relapse during the Follow-Up Phase, that subject is informed that use of nicotine replacement therapy or a smokefree tobacco product is a better option in terms of health risks than a smoking relapse.
Interventions
DRUGLow-nitrosamine smokefree tobacco product for oral use
Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke \>15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
OTHERNon-tobacco, non-nicotine placebo product
Placebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke \>15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
Sponsors
Swedish Match AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Cigarette smoker who smoke more than 9 cigarettes per day (average during past month) * Daily smoking more than 1 year * Motivated to quit smoking using a smokefree tobacco product * Good general health
Exclusion criteria
* Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months * Unable to refrain from nicotine replacement therapy during the study * Current oral condition that could be made worse by study interventions * History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation * History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation * History of alcohol or substance abuse other than cigarette smoking within the past year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm | Week 6-28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale | Baseline, week 6, 10, 16 and 28 | — |
| Fagerström Test for Nicotine Dependence | Baseline, week 16 and 28 | — |
| Biomarkers | Baseline, week 6, 16, and 28 | — |
| Point Prevalence Smoking Cessation | 6, 16, 28 weeks | 7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less |
| Continuous Smoking Cessation | 6-16 weeks | Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits |
Countries
United States
Participant flow
Recruitment details
Participants recruited from database of clinical trial volunteers, and media ads
Pre-assignment details
Participants were checked for eligibility prior to group assignment
Participants by arm
| Arm | Count |
|---|---|
| Active Snus Tobacco-based, smokefree product | 125 |
| Placebo Snus Non-tobacco, non-nicotine placebo product | 125 |
| Total | 250 |
Baseline characteristics
| Characteristic | Active Snus | Placebo Snus | 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 | 125 Participants | 125 Participants | 250 Participants |
| Region of Enrollment United States | 125 participants | 125 participants | 250 participants |
| Sex: Female, Male Female | 81 Participants | 71 Participants | 152 Participants |
| Sex: Female, Male Male | 44 Participants | 54 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 125 | 37 / 125 |
| serious Total, serious adverse events | 2 / 125 | 2 / 125 |
Outcome results
Primary
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm
Time frame: Week 6-28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Snus | Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm | 5 participants |
| Placebo Snus | Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm | 2 participants |
Secondary
Biomarkers
Time frame: Baseline, week 6, 16, and 28
Secondary
Continuous Smoking Cessation
Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits
Time frame: 6-16 weeks
Secondary
Fagerström Test for Nicotine Dependence
Time frame: Baseline, week 16 and 28
Secondary
Minnesota Nicotine Withdrawal Scale
Time frame: Baseline, week 6, 10, 16 and 28
Secondary
Point Prevalence Smoking Cessation
7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less
Time frame: 6, 16, 28 weeks