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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA121165 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.
Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 4 mg nicotine lozenges for 3 months |
|
| B | Placebo Comparator | Placebo nicotine lozenges for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Lozenges | Drug | Nicotine lozenges, 4 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged Smokeless Tobacco Abstinence at 3 Months | Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Point Prevalence All Tobacco Abstinence at 3 Months | Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit. | 3 months |
| Prolonged Smokeless Tobacco Abstinence at 6 Months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon O. Ebbert, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Oregon Research Institute |
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The study was conducted at the Mayo Clinic in Rochester, MN, and the Oregon Research Institute (ORI) in Eugene, OR. Enrollment took place between January, 2007 and April, 2008. Smokeless tobacco (ST) users were recruited through press releases and advertising from the surrounding communities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Lozenge | Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. |
| FG001 | Placebo Nicotine Lozenge | Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Lozenge | Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Prolonged Smokeless Tobacco Abstinence at 3 Months | Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline. | ITT | Posted | Number | Participants | 3 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine Lozenge | Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reflux | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon O. Ebbert, MD | Mayo Clinic | 507-266-1944 | nicotineresearch@mayo.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Placebo lozenge | Drug | Placebo lozenge |
|
Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).
| 6 months |
| Eugene |
| Oregon |
| 97403 |
| United States |
| Adverse Event |
|
| BG001 | Placebo Nicotine Lozenge | Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ST Use | Can's week | Mean | Standard Deviation | Cans/week |
|
| Placebo Nicotine Lozenge |
Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. |
|
|
|
| Secondary | Self-reported Point Prevalence All Tobacco Abstinence at 3 Months | Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit. | Posted | Number | Participants | 3 months |
|
|
|
| Secondary | Prolonged Smokeless Tobacco Abstinence at 6 Months | Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks). | Posted | Number | Participants | 6 months |
|
|
|
| 0 |
| 136 |
| 33 |
| 136 |
| EG001 | Placebo Nicotine Lozenge | Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours. | 0 | 134 | 17 | 134 |
| Sleep disturbance | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
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| D001519 | Behavior |