Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: nicotine lozenges; Drug: tobacco-free snuff

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Oregon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institutes of Health (NIH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: November 19, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (ESTIMATE): November 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: tobacco dependence; chewing tobacco; snuff; tobacco reduction; moist snuff
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 09-005172