Tobacco Use Disorder
Conditions
Keywords
Nicotine Dependence, Tobacco Dependence
Brief summary
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.
Detailed description
Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users. This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.
Interventions
DRUGUsual Care Group
Nicotine replacement therapy
OTHERReduction Group
Subject selects preferred method for reduction.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* No interest in stopping ST use within 90 days of study entry * Daily use of ST in the 6 months prior to study entry
Exclusion criteria
* Current use of tobacco or nicotine products, other than ST * Current unstable medical and mental health conditions * Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) | 12 weeks | No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO) |
| Percent Prolonged Abstinence From Tobacco at Week 12 | 12 weeks | Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO) |
| Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) | 26 week | Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date) |
| Percent Prolonged Abstinence From Tobacco at Week 26 | 26 weeks | Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care). |
| Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) | 32 Weeks | Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care). |
| Percent Prolonged Abstinence From Tobacco at Week 32 | 32 Weeks | Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 3/2007 through 5/2008.
Pre-assignment details
Subjects who called the clinic were randomized to usual care (immediate cessation) or tobacco reduction to quit. Those who did not meet eligibility criteria at their first clinic visit due to unstable health, tobacco use rate, or other exclusionary criteria were dropped from the study.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Group Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period. | 97 |
| Reduction Group Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure. | 102 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Randomized but did not enter treatment | 66 | 67 |
| Overall Study | Withdrawal by Subject | 36 | 47 |
Baseline characteristics
| Characteristic | Reduction Group | Usual Care Group | 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 | 102 Participants | 97 Participants | 199 Participants |
| Age, Continuous | 35.1 years STANDARD_DEVIATION 8.6 | 34.4 years STANDARD_DEVIATION 8.4 | 34.8 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 102 participants | 97 participants | 199 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 102 Participants | 97 Participants | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 97 | 25 / 102 |
| serious Total, serious adverse events | 0 / 97 | 0 / 102 |
Outcome results
Primary
Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)
No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)
Time frame: 12 weeks
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Group | Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) | 31 percentage of randomized |
| Reduction Group | Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) | 17 percentage of randomized |
Comparison: The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.p-value: 0.0495% CI: [0.26, 0.99]Chi-squared
Primary
Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)
Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)
Time frame: 26 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Group | Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) | 20 percentage of randomized |
| Reduction Group | Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) | 10 percentage of randomized |
Comparison: The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.p-value: 0.0395% CI: [0.18, 0.94]Chi-squared
Primary
Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)
Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).
Time frame: 32 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Group | Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) | 20 percentage of randomized |
| Reduction Group | Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) | 11 percentage of randomized |
Comparison: The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.p-value: 0.05695% CI: [0.2, 1.03]Chi-squared
Primary
Percent Prolonged Abstinence From Tobacco at Week 12
Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Group | Percent Prolonged Abstinence From Tobacco at Week 12 | 13 percentage of randomized |
| Reduction Group | Percent Prolonged Abstinence From Tobacco at Week 12 | 4 percentage of randomized |
Comparison: The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.p-value: 0.01995% CI: [0.07, 0.83]Chi-squared
Primary
Percent Prolonged Abstinence From Tobacco at Week 26
Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
Time frame: 26 weeks
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Group | Percent Prolonged Abstinence From Tobacco at Week 26 | 11 percentage of randomized |
| Reduction Group | Percent Prolonged Abstinence From Tobacco at Week 26 | 1 percentage of randomized |
Comparison: The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.p-value: 0.00295% CI: [0.004, 0.48]Chi-squared
Primary
Percent Prolonged Abstinence From Tobacco at Week 32
Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
Time frame: 32 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Group | Percent Prolonged Abstinence From Tobacco at Week 32 | 11 percentage of randomized |
| Reduction Group | Percent Prolonged Abstinence From Tobacco at Week 32 | 1 percentage of randomized |
Comparison: The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.p-value: 0.00295% CI: [0.004, 0.48]Chi-squared