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Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

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ClinicalTrials.gov Identifier: NCT00392379
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : August 30, 2010
Last Update Posted : April 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Smokeless Tobacco Use Drug: Nicotine Lozenges Drug: Placebo lozenge Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Study Start Date : January 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
4 mg nicotine lozenges for 3 months
Drug: Nicotine Lozenges
Nicotine lozenges, 4 mg
Other Name: Commit nicotine lozenge

Placebo Comparator: B
Placebo nicotine lozenges for 3 months
Drug: Placebo lozenge
Placebo lozenge




Primary Outcome Measures :
  1. Prolonged Smokeless Tobacco Abstinence at 3 Months [ Time Frame: 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 :
  1. Self-reported Point Prevalence All Tobacco Abstinence at 3 Months [ Time Frame: 3 months ]
    Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.

  2. Prolonged Smokeless Tobacco Abstinence at 6 Months [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392379


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jon O. Ebbert, M.D. Mayo Clinic
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Responsible Party: Jon Ebbert, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00392379    
Other Study ID Numbers: 06-003091
R01CA121165 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2006    Key Record Dates
Results First Posted: August 30, 2010
Last Update Posted: April 24, 2013
Last Verified: April 2013
Keywords provided by Jon Ebbert, Mayo Clinic:
Tobacco use disorder
Tobacco cessation
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action