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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA142952-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Mayo Clinic | OTHER |
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This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions:
Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.
The overarching aim of this line of research is to develop effective ST interventions that can be disseminated. In order to accomplish our aims, the investigators will enroll 1011 ST users in a multicenter, randomized controlled trial.
The primary aims and hypotheses to be tested in this study are the following:
To evaluate the effectiveness of a ST intervention combining the nicotine lozenge and assisted self-help (LASH) for increasing both prolonged and point prevalence all tobacco and ST abstinence rates at 6 months follow-up compared to an assisted self-help intervention (ASH)among ST users who are interested in achieving tobacco abstinence.
Hypothesis: The LASH intervention - adding the lozenge as nicotine replacement therapy(NRT)- will significantly increase both the prolonged and point prevalence all tobacco and ST abstinence rates compared to the ASH intervention at 6 months among ST users who are interested in achieving tobacco abstinence.
To evaluate the effectiveness of a ST intervention combining the nicotine lozenge and assisted self-help (LASH) for increasing both prolonged and point prevalence all tobacco and ST abstinence rates at 6 months follow-up compared to a lozenge plus self-help intervention (LSH group: no telephone counseling) among ST users who are interested in achieving tobacco abstinence.
Hypothesis: The LASH intervention will significantly increase the point prevalence abstinence rates of all tobacco and ST at 6 months compared to the LSH intervention among ST users who are interested in achieving tobacco abstinence.
Secondary aims to be tested in this study:
The investigators will also examine an exploratory aim:
1. The primary outcome for the exploratory aim is to compare the rate of nicotine metabolism with ST abstinence. Prior research with cigarette smokers shows that the Nicotine Metabolite Ratio (NMR) [i.e., ratio of trans-3'-hydroxycotinine to cotinine) is a predictor of smoking cessation success in particular that "faster metabolizers" treated with NRT or placebo had lower quit rates compared to "slower metabolizers". The exploratory aim will test this association with Smokeless Tobacco users. The number of lozenges used is a data point to help inform this evaluation.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lozenge Self Help: self help materials & lozenge NRT. | Active Comparator | Self-help materials + Commit® nicotine lozenges (4 mg) |
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| Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials | Experimental | Self-help materials + Commit® nicotine lozenges (4 mg) + Phone counseling |
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| Assisted Self-Help: self-help materials & phone counseling without lozenges | Experimental | Self-help materials + Phone counseling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commit® nicotine lozenges (4 mg) & self-help materials | Drug | Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) & instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation. |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged All Tobacco Abstinence | The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva Test for Bio-chemical Verification of Tobacco Abstinence | To verify self-report of prolonged abstinence, saliva will be collected once at 6 months. A salivary cotinine of < 15 ng/mL will be adjudicated as prolonged tobacco abstinence. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert H Severson, PhD | Oregon Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Research Insititute | Eugene | Oregon | 97403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25977408 | Result | Ebbert JO, Severson HH, Danaher BG, Benowitz NL, Schroeder DR. Nicotine Metabolite Ratio Is Associated With Lozenge Use But Not Quitting in Smokeless Tobacco Users. Nicotine Tob Res. 2016 Mar;18(3):366-70. doi: 10.1093/ntr/ntv102. Epub 2015 May 14. | |
| 25168034 | Result | Severson HH, Danaher BG, Ebbert JO, van Meter N, Lichtenstein E, Widdop C, Crowley R, Akers L, Seeley JR. Randomized trial of nicotine lozenges and phone counseling for smokeless tobacco cessation. Nicotine Tob Res. 2015 Mar;17(3):309-15. doi: 10.1093/ntr/ntu145. Epub 2014 Aug 28. |
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| Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials | Behavioral | Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation. |
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| Phone counseling & self-help materials | Behavioral | Three phone counseling sessions to assist in cessation from use of all tobacco + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation. |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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