Smokeless Tobacco Use
Conditions
Keywords
Tobacco use disorder, Tobacco cessation
Brief summary
This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.
Detailed description
Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment
Interventions
Nicotine lozenges, 4 mg
DRUGPlacebo lozenge
Placebo lozenge
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* are at least 18 years of age; * report smokeless tobacco (ST) as their primary tobacco of use; * have used ST daily for the past 6 months; * are in general good health (determined by medical history and screening physical examination); * have been provided with, understand, and have signed the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Smokeless Tobacco Abstinence at 3 Months | 3 months | Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Point Prevalence All Tobacco Abstinence at 3 Months | 3 months | Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit. |
| Prolonged Smokeless Tobacco Abstinence at 6 Months | 6 months | Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at the Mayo Clinic in Rochester, MN, and the Oregon Research Institute (ORI) in Eugene, OR. Enrollment took place between January, 2007 and April, 2008. Smokeless tobacco (ST) users were recruited through press releases and advertising from the surrounding communities.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Lozenge Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. | 136 |
| Placebo Nicotine Lozenge Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. | 134 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 9 |
| Overall Study | Withdrawal by Subject | 17 | 28 |
Baseline characteristics
| Characteristic | Total | Nicotine Lozenge | Placebo Nicotine Lozenge |
|---|---|---|---|
| Age Continuous | 36.6 years STANDARD_DEVIATION 10.8 | 36.6 years STANDARD_DEVIATION 10.7 | 36.5 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 270 participants | 136 participants | 134 participants |
| Sex: Female, Male Female | 6 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 264 Participants | 136 Participants | 128 Participants |
| ST Use | 4.2 Cans/week STANDARD_DEVIATION 2.6 | 4.3 Cans/week STANDARD_DEVIATION 2.6 | 4.2 Cans/week STANDARD_DEVIATION 2.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 136 | 17 / 134 |
| serious Total, serious adverse events | 0 / 136 | 0 / 134 |
Outcome results
Primary
Prolonged Smokeless Tobacco Abstinence at 3 Months
Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.
Time frame: 3 months
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Lozenge | Prolonged Smokeless Tobacco Abstinence at 3 Months | 65 Participants |
| Placebo Nicotine Lozenge | Prolonged Smokeless Tobacco Abstinence at 3 Months | 41 Participants |
Comparison: Based upon previous research, we hypothesized that the end-of-treatment abstinence rate for subjects receiving placebo would be 35% and the abstinence rate for subjects receiving the 4-mg nicotine lozenge would be 53%. A resulting power calculation indicated that 270 subjects (135 per group) were required in order to have 85% power to detect a significant difference (two-sided, α = 0.05 level test).p-value: <0.05Regression, Logistic
Secondary
Prolonged Smokeless Tobacco Abstinence at 6 Months
Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Lozenge | Prolonged Smokeless Tobacco Abstinence at 6 Months | 41 Participants |
| Placebo Nicotine Lozenge | Prolonged Smokeless Tobacco Abstinence at 6 Months | 31 Participants |
Secondary
Self-reported Point Prevalence All Tobacco Abstinence at 3 Months
Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Lozenge | Self-reported Point Prevalence All Tobacco Abstinence at 3 Months | 60 Participants |
| Placebo Nicotine Lozenge | Self-reported Point Prevalence All Tobacco Abstinence at 3 Months | 39 Participants |