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Varenicline for the Treatment of Smokeless Tobacco (CHANCHEW)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00813917
First received: December 22, 2008
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Nicotine Dependence
 Drug: varenicline
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline for the Treatment of Smokeless Tobacco Use

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 7-day Point Prevalence All Tobacco Abstinence [ Time Frame: 12 weeks - end of treatment ] [ Designated as safety issue: No ]
    7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml


Enrollment: 76
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline Drug: varenicline
12 weeks of varenicline 1 mg by mouth twice per day
Other Name: Chantix
Placebo Comparator: Placebo Drug: placebo
12 weeks of placebo (double blinded) by mouth twice per day
Other Name: Chantix placebo

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 cancer as well as cardiovascular and cerebrovascular disease. To date, no pharmacotherapies have been shown to increase long-term (≥ 6 months) abstinence rates in ST users. Novel pharmacotherapies that decrease withdrawal symptoms and nicotine self-administration need to be tested in ST users. 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. To evaluate this hypothesis, we will conduct a pilot study to obtain preliminary estimates of efficacy of 12-weeks of varenicline for increasing the prolonged and point prevalence tobacco abstinence rates at 12 weeks (end-of-treatment) in ST users. We will also evaluate the effect of varenicline on nicotine withdrawal symptoms and tobacco craving. If the results are promising, we will plan for a multicenter, randomized, double-blinded, placebo-controlled clinical trial with the Oregon Research Institute in Eugene, OR, to investigate the efficacy of varenicline to increase long-term (≥ 6 months) abstinence rates in ST users.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813917

Locations
United States, Minnesota
Nicotine Research Program
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jon O. Ebbert, M.D. Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jon Ebbert, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00813917     History of Changes
Other Study ID Numbers: 08-005359, CA132621-01A1
Study First Received: December 22, 2008
Results First Received: August 5, 2011
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Lobeline
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013