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Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Primary Purpose

Smokeless Tobacco Use

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nicotine Lozenges
Placebo lozenge
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smokeless Tobacco Use focused on measuring Tobacco use disorder, Tobacco cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

4 mg nicotine lozenges for 3 months

Placebo nicotine lozenges for 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
October 24, 2006
Last Updated
April 16, 2013
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00392379
Brief Title
Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Official Title
Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smokeless Tobacco Use
Keywords
Tobacco use disorder, Tobacco cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
4 mg nicotine lozenges for 3 months
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo nicotine lozenges for 3 months
Intervention Type
Drug
Intervention Name(s)
Nicotine Lozenges
Other Intervention Name(s)
Commit nicotine lozenge
Intervention Description
Nicotine lozenges, 4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo lozenge
Intervention Description
Placebo lozenge
Primary Outcome Measure Information:
Title
Prolonged Smokeless Tobacco Abstinence at 3 Months
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Self-reported Point Prevalence All Tobacco Abstinence at 3 Months
Description
Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.
Time Frame
3 months
Title
Prolonged Smokeless Tobacco Abstinence at 6 Months
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon O. Ebbert, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

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