Smokeless Tobacco Use
Conditions
Keywords
tobacco, chew, nrt, nicotine lozenges, self-help
Brief summary
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Detailed description
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.
Interventions
DRUGplacebo NRT
Placebo nicotine lozenges
DRUGnicotine replacement therapy
4 mg nicotine lozenges, ad lib, for 12 weeks.
Sponsors
Oregon Research Institute
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. male; 2. ≥18 years of age; 3. report ST as their primary tobacco of use; 4. have used ST daily for the past 6 months; 5. indicate that they want to quit; 6. have been provided with, understand, and have signed the informed consent.
Exclusion criteria
1. previously enrolled in a study involving the use of the nicotine lozenge; 2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program; 3. currently enrolled in another research study; 4. 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 PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic; 5. have phenylketonuria (PKU) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\]; 6. have another member of their household already participating in this study; 7. have other medical or psychiatric conditions that would exclude the participant; 8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Tobacco Abstinence | 12 weeks | self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment) |
Countries
United States
Participant flow
Recruitment details
The first person was pre-screened on 05/20/08 and the last person was randomized on 09/29/08.
Participants by arm
| Arm | Count |
|---|---|
| Active 4 mg nicotine lozenges | 30 |
| Placebo placebo nicotine lozenges (similar in appearance to the 4 mg lozenge) | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Active | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 16 | 42.4 years STANDARD_DEVIATION 11.7 | 43.0 years STANDARD_DEVIATION 13.9 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
| Smokeless tobacco | 3.9 cans/week STANDARD_DEVIATION 3.1 | 3.7 cans/week STANDARD_DEVIATION 2.1 | 3.8 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 | 3 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Number of Participants With Tobacco Abstinence
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
Time frame: 12 weeks
Population: intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active | Number of Participants With Tobacco Abstinence | 14 participants |
| Placebo | Number of Participants With Tobacco Abstinence | 11 participants |
p-value: 0.432Chi-squared