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Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939029
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : April 25, 2014
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic

Brief Summary:
Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.

Condition or disease Intervention/treatment Phase
Smokeless Tobacco Use Drug: nicotine replacement therapy (nicotine patches) Drug: placebo NRT Phase 2 Phase 3

Detailed Description:

Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality.

A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
Study Start Date : July 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Active
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
Drug: nicotine replacement therapy (nicotine patches)
2- 21 mg patches per day for 8 weeks

Placebo Comparator: placebo
2 patches (containing non active ingredients) per day for 8 weeks
Drug: placebo NRT
2 placebo patches (containing no active ingredient)per day for 8 weeks

Primary Outcome Measures :
  1. End of Treatment (Week 8) Point Prevalence Abstinence [ Time Frame: weeks 8 ]
    7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml

Secondary Outcome Measures :
  1. Point-prevalence Abstinence at 3 Months [ Time Frame: week 12 ]
    7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml

  2. Point-prevalence Abstinence at 6 Months [ Time Frame: week 24 ]
    7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. are at least 18 years of age and at most 55 years of age;
  2. report daily ST use for the past 12 months;
  3. identify ST as their primary tobacco product;
  4. use an average of ≥ 3 cans/pouches per week;
  5. are in general good health (determined by medical history and screening physical examination);
  6. have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

  1. are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
  2. are currently pregnant or lactating;
  3. have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;
  4. have a history of arrhythmia or an abnormal tracing on the baseline EKG;
  5. have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;
  6. have a history of severe skin allergies or dermatoses;
  7. have a history of intolerance to nicotine patches;
  8. have another member of their household already participating in this study;
  9. are taking a medication known to interact with nicotine (i.e., clozapine);
  10. are taking any prescription medication for depression or asthma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00939029

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Study Chair: Jon O Ebbert, MD Mayo Clinic
Publications of Results:
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Responsible Party: Jon Ebbert, Priniciple Investigator, Mayo Clinic Identifier: NCT00939029    
Other Study ID Numbers: 09-002581
First Posted: July 14, 2009    Key Record Dates
Results First Posted: April 25, 2014
Last Update Posted: May 19, 2014
Last Verified: May 2014
Keywords provided by Jon Ebbert, Mayo Clinic:
tobacco use
smokeless tobacco
chewing tobacco
nicotine replacement
tobacco dependence
tobacco cessation
tobacco abstinence
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action