Clinical trial NCT00888459: A Pilot Study Evaluating Nicotine Lozenges and Self Help
Official title: A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smokeless Tobacco Use
Keywords: tobacco
chew
nrt
nicotine lozenges
self-help
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Oregon Research Institute
First posted: 2009-04-27
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Number of Participants With Tobacco Abstinence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Mayo Clinic
name: Jon O Ebbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users. Addict Behav. 2010 May;35(5):522-5. doi: 10.1016/j.addbeh.2009.12.020. Epub 2010 Jan 4.