Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 24, 2006

Last Updated Date

December 22, 2008

Start Date ^†

October 2006

Current Primary Outcome Measures ^†

Prolonged tobacco abstinence at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Point prevalence tobacco abstinence at 3 and 6 months
Prolonged tobacco abstinence at 3 and 6 months

Change History

Complete list of historical versions of study NCT00392379 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Point prevalence smokeless tobacco abstinence at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Prolonged smokeless tobacco abstinence at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Point prevalence smokeless tobacco abstinence at 3 and 6 months
Prolonged smokeless tobacco abstinence at 3 and 6 months

Descriptive Information

Brief Title ^†

Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Official Title ^†

Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Brief 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.

Detailed Description

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 238 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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Smokeless Tobacco Use

Intervention ^†

Drug: Nicotine Lozenges

Study Arms / Comparison Groups

Experimental: 4 mg nicotine lozenges for 3 months
Placebo Comparator: Placebo nicotine lozenges for 3 months

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

238

Estimated Completion Date

June 2009

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

are at least 18 years of age;
report 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00392379

Responsible Party

Jon O. Ebbert, MD, Mayo Clinic

Secondary IDs ^††

R01 CA121165

Study Sponsor ^†

Mayo Clinic

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Jon O. Ebbert, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.