A Pilot Study Evaluating Nicotine Lozenges and Self Help

Smokeless Tobacco Use Clinical Trial

Official title:

A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888459
• Other study ID #: 07-008574
• Secondary ID: CA121165
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.

Description:

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. male;

2. =18 years of age;

3. report ST as their primary tobacco of use;

4. have used ST daily for the past 6 months;

5. indicate that they want to quit;

6. have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

1. previously enrolled in a study involving the use of the nicotine lozenge;

2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;

3. currently enrolled in another research study;

4. 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 PSVT; or d) medically-treated or untreated hypertension with BP = 180 systolic OR = 100 diastolic;

5. have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];

6. have another member of their household already participating in this study;

7. have other medical or psychiatric conditions that would exclude the participant;

8. have a score of = 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.

Related Conditions & MeSH terms

• Smokeless Tobacco Use

Intervention

Drug:
• nicotine replacement therapy
4 mg nicotine lozenges, ad lib, for 12 weeks.
• placebo NRT
Placebo nicotine lozenges

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	Oregon Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users. Addict Behav. 2010 May;35(5):522-5. doi: 10.1016/j.addbeh.2009.12.020. Epub 2010 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Tobacco Abstinence	self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)	12 weeks