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| ID | Type | Description | Link |
|---|---|---|---|
| CA121165 |
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| Name | Class |
|---|---|
| Oregon Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active | Active Comparator | Self-help counseling material and 4 mg nicotine lozenges |
|
| 2 | Placebo Comparator | self help counseling material and placebo nicotine lozenges |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine replacement therapy | Drug | 4 mg nicotine lozenges, ad lib, for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tobacco Abstinence | self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon O Ebbert, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Oregon Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20060229 | Result | Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users. Addict Behav. 2010 May;35(5):522-5. doi: 10.1016/j.addbeh.2009.12.020. Epub 2010 Jan 4. |
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The first person was pre-screened on 05/20/08 and the last person was randomized on 09/29/08.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | 4 mg nicotine lozenges |
| FG001 | Placebo | placebo nicotine lozenges (similar in appearance to the 4 mg lozenge) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | 4 mg nicotine lozenges |
| BG001 | Placebo | placebo nicotine lozenges (similar in appearance to the 4 mg lozenge) |
| 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 | Number of Participants With Tobacco Abstinence | self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment) | intention to treat | Posted | Number | participants | 12 weeks |
|
|
12 weeks
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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 | Active | 4 mg nicotine lozenges |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon O. Ebbert | Mayo Clinic | 507-266-1944 | ebbert.jon@mayo.edu |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| placebo NRT | Drug | Placebo nicotine lozenges |
|
|
| Eugene |
| Oregon |
| 97403 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Smokeless tobacco | Mean | Standard Deviation | cans/week |
|
| Participants |
|
|
|
| 0 |
| 30 |
| 3 |
| 30 |
| EG001 | Placebo | placebo nicotine lozenges (similar in appearance to the 4 mg lozenge) | 0 | 30 | 0 | 30 |
| Sleep disturbance | Psychiatric disorders | Non-systematic Assessment |
|
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