Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00939029
First received: July 10, 2009
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Smokeless Tobacco Use
Drug: nicotine replacement therapy (nicotine patches)
Drug: placebo NRT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • End of Treatment (Week 8) Point Prevalence Abstinence [ Time Frame: weeks 8 ] [ Designated as safety issue: No ]
    7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml


Secondary Outcome Measures:
  • Point-prevalence Abstinence at 3 Months [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml

  • Point-prevalence Abstinence at 6 Months [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.


Enrollment: 52
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939029

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Jon O Ebbert, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Jon Ebbert, Priniciple Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00939029     History of Changes
Other Study ID Numbers: 09-002581, CA140125, 09-001763
Study First Received: July 10, 2009
Results First Received: March 25, 2014
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
tobacco use
smokeless tobacco
chewing tobacco
snuff
nicotine replacement
tobacco dependence
tobacco cessation
tobacco abstinence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Lobeline
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014