Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
NCT ID: NCT01341938
Last Updated: 2021-08-04
Study Results
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Basic Information
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COMPLETED
NA
1067 participants
INTERVENTIONAL
2011-07-31
2012-11-30
Brief Summary
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1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials
2. Assisted Self-Help intervention - self-help materials and phone counseling without lozenges
3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy.
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.
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Detailed Description
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The primary aims and hypotheses to be tested in this study are the following:
1. 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.
2. 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:
1. To evaluate the incremental cost-per-quit of adding the nicotine lozenge to an assisted self-help intervention (or of adding an assisted self-help intervention to a nicotine lozenge intervention)for increasing tobacco abstinence rates.
2. To evaluate changes in self-efficacy and other theoretically-relevant measures related to the use of the nicotine lozenge as potential mediators of tobacco abstinence.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lozenge Self Help: self help materials & lozenge NRT.
Self-help materials + Commit® nicotine lozenges (4 mg)
Commit® nicotine lozenges (4 mg) & self-help materials
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.
Phone counseling & self-help materials
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.
Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials
Self-help materials + Commit® nicotine lozenges (4 mg) + Phone counseling
Commit® nicotine lozenges (4 mg) & self-help materials
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.
Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials
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.
Phone counseling & self-help materials
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.
Assisted Self-Help: self-help materials & phone counseling without lozenges
Self-help materials + Phone counseling
Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials
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.
Phone counseling & self-help materials
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.
Interventions
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Commit® nicotine lozenges (4 mg) & self-help materials
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.
Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials
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.
Phone counseling & self-help materials
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently using smokeless tobacco products as primary tobacco product
* Use smokeless tobacco for the last 6 months
* Currently want to quit
* Able to read and write English; and
* Willing to share phone number, e-mail, and mailing address with the research project
* complete informed consent process
Exclusion Criteria
* medical history of unstable angina, myocardial infarction within the past 6 months, cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT or medically treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic
* have phenylketonuria (PKU)
* have another member of their household already participating in this study
* currently pregnant or nursing
* score of ≥ 15 on the Patient Health Questionnaire (PHQ-8)
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Oregon Research Institute
OTHER
Responsible Party
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Principal Investigators
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Herbert H Severson, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Research Institute
Locations
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Oregon Research Insititute
Eugene, Oregon, United States
Countries
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References
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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.
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.
Other Identifiers
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