A Pilot Study Evaluating Nicotine Lozenges and Self Help

NCT00888459 | Completed Phase 2 Results

• 2 other identifiers: 07-008574CA121165
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Smokeless Tobacco Use

Keywords

tobacco; chew; nrt; nicotine lozenges; self-help

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Tobacco Abstinence

  self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)

  12 weeks

Study Arms (2)

active

ACTIVE COMPARATOR

Self-help counseling material and 4 mg nicotine lozenges

Drug: nicotine replacement therapy

2

PLACEBO COMPARATOR

self help counseling material and placebo nicotine lozenges

Drug: placebo NRT

Interventions

nicotine replacement therapy DRUG

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

Also known as: Nicotine Lozenges

active

placebo NRT DRUG

Placebo nicotine lozenges

Also known as: placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previously enrolled in a study involving the use of the nicotine lozenge;
• currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
• currently enrolled in another research study;
• 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;
• have phenylketonuria (PKU) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\];
• have another member of their household already participating in this study;
• have other medical or psychiatric conditions that would exclude the participant;
• have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.

Sponsors & Collaborators

• Mayo Clinic: lead
• Oregon Research Institute: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

• 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.

  PMID: 20060229 RESULT

MeSH Terms

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Jon O. Ebbert
• Organization: Mayo Clinic

ebbert.jon@mayo.edu

507-266-1944

Study Officials

• Jon O Ebbert, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 27, 2009
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 23, 2023
• Results First Posted: November 4, 2010

Record last verified: 2023-10

Locations

US (2)