Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

Summary

This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions:

1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials
2. Assisted Self-Help intervention - self-help materials and phone counseling without lozenges
3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy.

Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.

Conditions

• Smokeless Tobacco Cessation

Interventions

DRUG

Commit® nicotine lozenges (4 mg) & self-help materials

Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) \& instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.

BEHAVIORAL

Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials

Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.

BEHAVIORAL

Phone counseling & self-help materials

Three phone counseling sessions to assist in cessation from use of all tobacco + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  collaborator OTHER

• Oregon Research Institute

  lead OTHER

Principal Investigators

• Herbert H Severson, PhD · Oregon Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2012-11-30

Completion

2012-11-30

Countries

• United States

Study Locations