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Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

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ClinicalTrials.gov Identifier: NCT01018394
Recruitment Status : Completed
First Posted : November 23, 2009
Results First Posted : September 13, 2013
Last Update Posted : September 13, 2013
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic

Study Description
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Brief Summary:
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: nicotine lozenges Drug: tobacco-free snuff Phase 2 Phase 3

Detailed Description:
In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction
Study Start Date : January 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: nicotine lozenges
40 subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
 Drug: nicotine lozenges
4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.
Active Comparator: tobacco free snuff
41 subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
 Drug: tobacco-free snuff
Tobacco-free snuff used ad lib for a maximum of 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Tobacco Abstinence at 12 Weeks [ Time Frame: week 12 ]
    Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.


Other Outcome Measures:
  1. Smokeless Tobacco Reduction Greater or Equal to 50% [ Time Frame: baseline, week 4 ]
    Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. at least 18 years of age;
  2. no intention of quitting in the next one month;
  3. report ST as their primary tobacco of use;
  4. have used ST daily for the past 12 months;
  5. have been provided with, understand, and have signed the informed consent
  6. are able to complete all study visits;
  7. are in general good health as determined by medical history.

Exclusion Criteria:

  1. currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program;
  2. currently enrolled in another research study;
  3. describe having a medical history of: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
  4. have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];
  5. have another member of their household already participating in this study;
  6. have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators;
  7. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen;
  8. are currently pregnant are trying to become pregnant;
  9. are currently breast-feeding and unwilling to stop during this study.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01018394


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Jon O Ebbert, MD Mayo Clinic
More Information
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Publications of Results:

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Responsible Party: Jon Ebbert, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01018394    
Other Study ID Numbers: 09-005172
First Posted: November 23, 2009    Key Record Dates
Results First Posted: September 13, 2013
Last Update Posted: September 13, 2013
Last Verified: September 2013
Keywords provided by Jon Ebbert, Mayo Clinic:
tobacco dependence
tobacco reduction
chewing tobacco
snuff
moist snuff
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
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