Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01-DA14404-4 | |||
| DPMCDA | |||
| R01DA014404 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | Active Comparator | Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied. |
|
| Reduction Group | Experimental | Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care Group | Drug | Nicotine replacement therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks |
| Percent Prolonged Abstinence From Tobacco at Week 12 | Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO) | 12 weeks |
| 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) | 26 week |
| 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). | 26 weeks |
| 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). | 32 Weeks |
| 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). | 32 Weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dorothy Hatsukami, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerisity of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22218402 | Result | Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res. 2012 Aug;14(8):902-9. doi: 10.1093/ntr/ntr302. Epub 2012 Jan 4. |
| Label | URL |
|---|---|
| Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res 2012. | View source |
Not provided
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.
Subjects were recruited from 3/2007 through 5/2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Group | Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period. |
| FG001 | Reduction Group | Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Reduction Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Intent to treat | Posted | Sep 2011 | Number | percentage of randomized | 12 weeks |
|
6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleep Disturbance | General disorders | Systematic Assessment |
Sample size was limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dorothy Hatsukami, Ph.D. | University of Minnesota | 612-626-2121 | hatsu001@umn.edu |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Reduction Group | Other | Subject selects preferred method for reduction. |
|
|
| Randomized but did not enter treatment |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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) | Posted | Number | percentage of randomized | 12 weeks |
|
|
|
|
| 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) | Posted | Number | percentage of randomized | 26 week |
|
|
|
|
| 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). | Intent to treat | Posted | Number | percentage of randomized | 26 weeks |
|
|
|
|
| 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). | Posted | Number | percentage of randomized | 32 Weeks |
|
|
|
|
| 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). | Posted | Number | percentage of randomized | 32 Weeks |
|
|
|
|
| 0 |
| 97 |
| 46 |
| 97 |
| EG001 | 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. | 0 | 102 | 25 | 102 |
| Dry Mouth | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Muscle Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Redness at Patch Site | General disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |