Smokeless Tobacco Use
Conditions
Keywords
tobacco use, smokeless tobacco, chewing tobacco, snuff, nicotine replacement, tobacco dependence, tobacco cessation, tobacco abstinence
Brief summary
Smokeless tobacco use (chewing) is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.
Detailed description
Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality. A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (\> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (\> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.
Interventions
2- 21 mg patches per day for 8 weeks
DRUGplacebo NRT
2 placebo patches (containing no active ingredient)per day for 8 weeks
Sponsors
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. are at least 18 years of age and at most 55 years of age; 2. report daily ST use for the past 12 months; 3. identify ST as their primary tobacco product; 4. use an average of ≥ 3 cans/pouches per week; 5. are in general good health (determined by medical history and screening physical examination); 6. have been provided with, understand, and have signed the informed consent.
Exclusion criteria
1. are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program; 2. are currently pregnant or lactating; 3. have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months; 4. have a history of arrhythmia or an abnormal tracing on the baseline EKG; 5. have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute; 6. have a history of severe skin allergies or dermatoses; 7. have a history of intolerance to nicotine patches; 8. have another member of their household already participating in this study; 9. are taking a medication known to interact with nicotine (i.e., clozapine); 10. are taking any prescription medication for depression or asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End of Treatment (Week 8) Point Prevalence Abstinence | weeks 8 | 7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine \< 2 ng per ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Point-prevalence Abstinence at 3 Months | week 12 | 7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine \< 2 ng per ml |
| Point-prevalence Abstinence at 6 Months | week 24 | 7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine \< 2 ng per ml. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active 2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks | 25 |
| Placebo 2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 7 |
Baseline characteristics
| Characteristic | Active | Placebo | 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 | 25 Participants | 27 Participants | 52 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 9.1 | 35.3 years STANDARD_DEVIATION 9.5 | 37.2 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Caucasian, Hispanic | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Caucasian, non-Hispanic | 23 participants | 26 participants | 49 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 27 Participants | 52 Participants |
| Smokeless tobacco use | 4.6 cans or pouches per week STANDARD_DEVIATION 1.8 | 4.0 cans or pouches per week STANDARD_DEVIATION 1.3 | 4.3 cans or pouches per week STANDARD_DEVIATION 1.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 25 | 4 / 27 |
| serious Total, serious adverse events | 1 / 25 | 0 / 27 |
Outcome results
Primary
End of Treatment (Week 8) Point Prevalence Abstinence
7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine \< 2 ng per ml
Time frame: weeks 8
Population: intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active | End of Treatment (Week 8) Point Prevalence Abstinence | 11 participants |
| Placebo | End of Treatment (Week 8) Point Prevalence Abstinence | 6 participants |
p-value: 0.0590% CI: [1, 7.5]Regression, Logistic
Secondary
Point-prevalence Abstinence at 3 Months
7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine \< 2 ng per ml
Time frame: week 12
Population: intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active | Point-prevalence Abstinence at 3 Months | 12 participants |
| Placebo | Point-prevalence Abstinence at 3 Months | 5 participants |
p-value: 0.01490% CI: [1.4, 11.6]Regression, Logistic
Secondary
Point-prevalence Abstinence at 6 Months
7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine \< 2 ng per ml.
Time frame: week 24
Population: intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active | Point-prevalence Abstinence at 6 Months | 11 participants |
| Placebo | Point-prevalence Abstinence at 6 Months | 7 participants |
p-value: 0.08790% CI: [0.8, 6]Regression, Logistic