A Pilot Study Evaluating Nicotine Lozenges and Self Help

NCT ID: NCT00888459

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-05-31

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.

Conditions

Smokeless Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active

Self-help counseling material and 4 mg nicotine lozenges

Group Type: ACTIVE_COMPARATOR

nicotine replacement therapy

Intervention Type: DRUG

4 mg nicotine lozenges, ad lib, for 12 weeks.

2

self help counseling material and placebo nicotine lozenges

Group Type: PLACEBO_COMPARATOR

placebo NRT

Intervention Type: DRUG

Placebo nicotine lozenges

Interventions

nicotine replacement therapy

4 mg nicotine lozenges, ad lib, for 12 weeks.

Intervention Type: DRUG

placebo NRT

Placebo nicotine lozenges

Intervention Type: DRUG

Other Intervention Names

Nicotine Lozenges; placebo

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Research Institute

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Jon O Ebbert, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Oregon Research Institute

Eugene, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20060229 (View on PubMed)

Other Identifiers

07-008574

Identifier Type: -

Identifier Source: org_study_id

CA121165

Identifier Type: -

Identifier Source: secondary_id