Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

NCT01018394 | Completed Phase 2 Results

• 1 other identifier: 09-005172
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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.

Conditions

Tobacco Dependence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Smokeless Tobacco Reduction Greater or Equal to 50%

  baseline, week 4

Study Arms (2)

nicotine lozenges

ACTIVE COMPARATOR

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

tobacco free snuff

ACTIVE COMPARATOR

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

Interventions

nicotine lozenges DRUG

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

nicotine lozenges

tobacco-free snuff DRUG

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

tobacco free snuff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related 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.

  PMID: 23454876 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Jon Ebbert
• Organization: Mayo Clinic

nicotineresearch@mayo.edu

507-266-1944

Study Officials

• Jon O Ebbert, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 13, 2013
• Results First Posted: September 13, 2013

Record last verified: 2013-09

Locations

US (2)