Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Tobacco Dependence Clinical Trial

Official title:

A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018394
• Other study ID #: 09-005172
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 19, 2009
• Last updated: September 11, 2013
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• nicotine lozenges
4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.
• tobacco-free snuff
Tobacco-free snuff used ad lib for a maximum of 12 weeks

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smokeless Tobacco Reduction Greater or Equal to 50%	Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline	baseline, week 4	No
Primary	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.	week 12	No