A Pilot Study Evaluating Nicotine Lozenges and Self Help

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888459
Recruitment Status : Completed
First Posted : April 27, 2009
Results First Posted : November 4, 2010
Last Update Posted : July 18, 2011
Oregon Research Institute
Information provided by:
Mayo Clinic

Brief Summary:
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.

Condition or disease Intervention/treatment Phase
Smokeless Tobacco Use Drug: nicotine replacement therapy Drug: placebo NRT Phase 2

Detailed Description:
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
Study Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: active
Self-help counseling material and 4 mg nicotine lozenges
Drug: nicotine replacement therapy
4 mg nicotine lozenges, ad lib, for 12 weeks.
Other Name: Nicotine Lozenges
Placebo Comparator: 2
self help counseling material and placebo nicotine lozenges
Drug: placebo NRT
Placebo nicotine lozenges
Other Name: placebo

Primary Outcome Measures :
  1. Number of Participants With Tobacco Abstinence [ Time Frame: 12 weeks ]
    self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. male;
  2. ≥18 years of age;
  3. report ST as their primary tobacco of use;
  4. have used ST daily for the past 6 months;
  5. indicate that they want to quit;
  6. have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

  1. previously enrolled in a study involving the use of the nicotine lozenge;
  2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
  3. currently enrolled in another research study;
  4. describe having a medical history of: a) unstable angina; b) myocardial infarction within the past 6 months; c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
  5. have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];
  6. have another member of their household already participating in this study;
  7. have other medical or psychiatric conditions that would exclude the participant;
  8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.

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 identifier (NCT number): NCT00888459

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
Oregon Research Institute
Principal Investigator: Jon O Ebbert, MD Mayo Clinic

Publications of Results:
Responsible Party: Jon Ebbert, MD, Mayo Clinic Identifier: NCT00888459     History of Changes
Other Study ID Numbers: 07-008574
First Posted: April 27, 2009    Key Record Dates
Results First Posted: November 4, 2010
Last Update Posted: July 18, 2011
Last Verified: July 2011

Keywords provided by Mayo Clinic:
nicotine lozenges

Additional relevant MeSH terms:
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