Tobacco Dependence
Conditions
Keywords
tobacco dependence, tobacco reduction, chewing tobacco, snuff, moist snuff
Brief summary
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.
Detailed description
In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.
Interventions
4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.
DRUGtobacco-free snuff
Tobacco-free snuff used ad lib for a maximum of 12 weeks
Sponsors
National Institutes of Health (NIH)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. at least 18 years of age; 2. no intention of quitting in the next one month; 3. report ST as their primary tobacco of use; 4. have used ST daily for the past 12 months; 5. have been provided with, understand, and have signed the informed consent 6. are able to complete all study visits; 7. are in general good health as determined by medical history.
Exclusion criteria
1. currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program; 2. currently enrolled in another research study; 3. describe having a medical history of: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic; 4. have phenylketonuria (PKU) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\]; 5. have another member of their household already participating in this study; 6. have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators; 7. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen; 8. are currently pregnant are trying to become pregnant; 9. are currently breast-feeding and unwilling to stop during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco Abstinence at 12 Weeks | week 12 | Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Smokeless Tobacco Reduction Greater or Equal to 50% | baseline, week 4 | Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline |
Countries
United States
Participant flow
Recruitment details
Recruitment began on February 2010 and completed on September 2011. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, Minnesota and Oregon Research Institute in Eugene, Oregon) for consenting and additional study procedures to determine eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Lozenges Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day. | 40 |
| Tobacco Free Snuff Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks | 41 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Tobacco Free Snuff | Nicotine Lozenges | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 36 Participants | 73 Participants |
| Age Continuous | 37.5 years STANDARD_DEVIATION 12.5 | 37.8 years STANDARD_DEVIATION 15.9 | 37.6 years STANDARD_DEVIATION 14.3 |
| Baseline tobacco used per week | 4.0 cans of smokeless tobacco STANDARD_DEVIATION 2.7 | 3.2 cans of smokeless tobacco STANDARD_DEVIATION 2.1 | 3.6 cans of smokeless tobacco STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 38 Participants | 40 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 40 | 1 / 41 |
| serious Total, serious adverse events | 0 / 40 | 0 / 41 |
Outcome results
Primary
Tobacco Abstinence at 12 Weeks
Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.
Time frame: week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Lozenges | Tobacco Abstinence at 12 Weeks | 8 participants |
| Tobacco Free Snuff | Tobacco Abstinence at 12 Weeks | 5 participants |
Other Pre-specified
Smokeless Tobacco Reduction Greater or Equal to 50%
Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline
Time frame: baseline, week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Lozenges | Smokeless Tobacco Reduction Greater or Equal to 50% | 25 percentage of participants |
| Tobacco Free Snuff | Smokeless Tobacco Reduction Greater or Equal to 50% | 19 percentage of participants |
Comparison: The percentage of participants who reduced tobacco use by greater or equal to 50% from baseline was compared between groups using Fisher's exact test. A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.p-value: 0.10895% CI: [0.7, 5.1]Fisher Exact