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Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nicotine lozenges
tobacco-free snuff
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring tobacco dependence, tobacco reduction, chewing tobacco, snuff, moist snuff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

nicotine lozenges

tobacco free snuff

Arm Description

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.

41 subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.

Outcomes

Primary Outcome Measures

Tobacco Abstinence at 12 Weeks
Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2009
Last Updated
September 11, 2013
Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01018394
Brief Title
Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction
Official Title
A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
tobacco dependence, tobacco reduction, chewing tobacco, snuff, moist snuff

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nicotine lozenges
Arm Type
Active Comparator
Arm Description
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.
Arm Title
tobacco free snuff
Arm Type
Active Comparator
Arm Description
41 subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
Intervention Type
Drug
Intervention Name(s)
nicotine lozenges
Intervention Description
4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.
Intervention Type
Drug
Intervention Name(s)
tobacco-free snuff
Intervention Description
Tobacco-free snuff used ad lib for a maximum of 12 weeks
Primary Outcome Measure Information:
Title
Tobacco Abstinence at 12 Weeks
Description
Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.
Time Frame
week 12
Other Pre-specified Outcome Measures:
Title
Smokeless Tobacco Reduction Greater or Equal to 50%
Description
Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline
Time Frame
baseline, week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: at least 18 years of age; no intention of quitting in the next one month; report ST as their primary tobacco of use; have used ST daily for the past 12 months; have been provided with, understand, and have signed the informed consent are able to complete all study visits; are in general good health as determined by medical history. Exclusion Criteria: currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program; currently enrolled in another research study; 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; have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU]; have another member of their household already participating in this study; have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators; have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen; are currently pregnant are trying to become pregnant; are currently breast-feeding and unwilling to stop during this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon O Ebbert, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23454876
Citation
Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. Comparative effectiveness of the nicotine lozenge and tobacco-free snuff for smokeless tobacco reduction. Addict Behav. 2013 May;38(5):2140-5. doi: 10.1016/j.addbeh.2013.01.023. Epub 2013 Feb 4.
Results Reference
result

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Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

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