Varenicline for the Treatment of Smokeless Tobacco

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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 increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Institutes of Health (NIH)
• Treatments: Lobeline; Varenicline

Criteria

Inclusion Criteria:

Subjects will be eligible to participate if they:

1. Are at least 18 years of age

2. Have used ST daily for the past 12 months (regular user)

3. Identify ST as their primary tobacco product

4. Are in general good health (determined by medical history and screening physical examination)

5. Has provided written informed consent to participate

6. Are able to participate in all aspects of the study

Exclusion Criteria:

Individuals will be excluded from study participation if they:

1. 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)

2. Have self-reported current, untreated depression or a Beck Depression Inventory (BDI-II) Score of ≥ 20

3. 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.")

4. History of psychosis or bipolar disorder

5. Are currently pregnant or lactating or is of childbearing potential and not willing to use any form of contraception

6. Have another member of their household already participating in this study

7. Are allergic to varenicline

8. 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