Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Conditions
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Smokeless Tobacco Use

Intervention / Treatment
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* Drug: Nicotine Lozenges
* Drug: Placebo lozenge


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>4 mg nicotine lozenges for 3 months | Drug: Nicotine Lozenges<br>* Nicotine lozenges, 4 mg<br>* Other names: Commit nicotine lozenge;|
| Placebo Comparator: B<br>Placebo nicotine lozenges for 3 months | Drug: Placebo lozenge<br>* Placebo lozenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco use disorder, Tobacco cessation