Smokeless Tobacco Cessation Clinical Trial
— LASHOfficial title:
Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
Verified date | July 2021 |
Source | Oregon Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: 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.
Status | Completed |
Enrollment | 1067 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years old or over - 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: - have used behavioral or pharmacologic tobacco treatment in last 30 days - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Research Insititute | Eugene | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Research Institute | Mayo Clinic, National Cancer Institute (NCI) |
United States,
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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