Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Smokeless Tobacco Use Clinical Trial

Official title:

Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392379
• Other study ID #: 06-003091
• Secondary ID: R01CA121165
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2006
• Last updated: April 16, 2013
• Start date: January 2007
• Est. completion date: March 2009

Study information

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

Clinical Trial Summary

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Description:

Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• are at least 18 years of age;

• report smokeless tobacco (ST) as their primary tobacco of use;

• have used ST daily for the past 6 months;

• are in general good health (determined by medical history and screening physical examination);

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smokeless Tobacco Use

Intervention

Drug:
• Nicotine Lozenges
Nicotine lozenges, 4 mg
• Placebo lozenge
Placebo lozenge

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 Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Smokeless Tobacco Abstinence at 3 Months	Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.	3 months	No
Secondary	Self-reported Point Prevalence All Tobacco Abstinence at 3 Months	Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.	3 months	No
Secondary	Prolonged Smokeless Tobacco Abstinence at 6 Months	Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).	6 months	No