Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

NCT ID: NCT01018394

Last Updated: 2013-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

Tobacco Dependence

Keywords

tobacco dependence; tobacco reduction; chewing tobacco; snuff; moist snuff

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

nicotine lozenges

Intervention Type: DRUG

4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.

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.

Group Type: ACTIVE_COMPARATOR

tobacco-free snuff

Intervention Type: DRUG

Tobacco-free snuff used ad lib for a maximum of 12 weeks

Interventions

nicotine lozenges

4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.

Intervention Type: DRUG

tobacco-free snuff

Tobacco-free snuff used ad lib for a maximum of 12 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jon Ebbert

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon O Ebbert, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Oregon Research Institute

Eugene, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23454876 (View on PubMed)

Other Identifiers

09-005172

Identifier Type: -

Identifier Source: org_study_id