A Pilot Study Evaluating Nicotine Lozenges and Self Help

This study has been completed.
Sponsor:
Collaborator:
Oregon Research Institute
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00888459
First received: April 24, 2009
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Smokeless Tobacco Use
Drug: nicotine replacement therapy
Drug: placebo NRT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Participants With Tobacco Abstinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)


Enrollment: 60
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888459

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

Publications:
Responsible Party: Jon Ebbert, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00888459     History of Changes
Other Study ID Numbers: 07-008574, CA121165
Study First Received: April 24, 2009
Results First Received: October 4, 2010
Last Updated: July 14, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
tobacco
chew
nrt
nicotine lozenges
self-help

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014