Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00392379

Purpose

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	Intervention	Phase
Smokeless Tobacco Use	Drug: Nicotine Lozenges	Phase III

MedlinePlus related topics: Smokeless Tobacco

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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

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 ]

Estimated Enrollment:	238
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
A: Experimental 4 mg nicotine lozenges for 3 months	Drug: Nicotine Lozenges Nicotine lozenges, 4 mg
B: Placebo Comparator Placebo nicotine lozenges for 3 months	Drug: Nicotine Lozenges Nicotine lozenges, 4 mg

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392379

Locations

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

Principal Investigator:

Jon O. Ebbert, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Jon O. Ebbert, MD )
Study ID Numbers:	06-003091, R01 CA121165
Study First Received:	October 24, 2006
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00392379 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Tobacco use disorder
Tobacco cessation

Study placed in the following topic categories:

Nicotine polacrilex
Neurotransmitter Agents
Lobeline
Behavior, Addictive
Nicotine

Nicotinic Agonists
Tobacco Use Disorder
Central Nervous System Stimulants
Peripheral Nervous System Agents
Cholinergic Agents

Additional relevant MeSH terms:

Nicotine polacrilex
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Nicotine
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009