Status:
COMPLETED
Varenicline for the Treatment of Smokeless Tobacco
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for incre...
Detailed Description
In the United States, approximately 7.7 million individuals older than 12 years of age report current (past month) use of smokeless tobacco (ST). ST use has been associated with oral and extra-oral ca...
Eligibility Criteria
Inclusion
- Subjects will be eligible to participate if they:
- Are at least 18 years of age
- Have used ST daily for the past 12 months (regular user)
- Identify ST as their primary tobacco product
- Are in general good health (determined by medical history and screening physical examination)
- Has provided written informed consent to participate
- Are able to participate in all aspects of the study
Exclusion
- Individuals will be excluded from study participation if they:
- Are currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation programs (i.e., behavioral therapy, nicotine replacement therapy, clonidine, bupropion SR, or doxepin)
- Have self-reported current, untreated depression or a Beck Depression Inventory (BDI-II) Score of ≥ 20
- Have, as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale);current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act.")
- History of psychosis or bipolar disorder
- Are currently pregnant or lactating or is of childbearing potential and not willing to use any form of contraception
- Have another member of their household already participating in this study
- Are allergic to varenicline
- Describe having a medical history of:
- Unstable angina
- Myocardial infarction within the past 3 months
- Cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT
- Medically-treated or untreated hypertension with BP ≥ 200 systolic OR ≥ 100 diastolic
- Have other medical or psychiatric conditions that would exclude the participant
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00813917
Start Date
February 1 2009
End Date
January 1 2011
Last Update
July 16 2012
Active Locations (1)
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1
Nicotine Research Program
Rochester, Minnesota, United States, 55905