Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01018394
First received: November 19, 2009
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Tobacco Dependence
Drug: nicotine lozenges
Drug: tobacco-free snuff
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Tobacco Abstinence at 12 Weeks [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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:
  • Smokeless Tobacco Reduction Greater or Equal to 50% [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline


Enrollment: 81
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01018394

Locations
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
Investigators
Principal Investigator: Jon O Ebbert, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Jon Ebbert, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01018394     History of Changes
Other Study ID Numbers: 09-005172
Study First Received: November 19, 2009
Results First Received: June 20, 2013
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
tobacco dependence
tobacco reduction
chewing tobacco
snuff
moist snuff

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

ClinicalTrials.gov processed this record on October 29, 2014