Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pilot Study Evaluating Nicotine Lozenges and Self Help

NCT00888459

Smokeless Tobacco Use

COMPLETED PHASE2

Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

NCT01018394

Tobacco Dependence

COMPLETED PHASE2/PHASE3

Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

NCT00985985

Smoking

COMPLETED PHASE3

Comparing NicoBloc to Nicotine Lozenges

NCT03720899

Smoking Cessation Nicotine Dependence

COMPLETED PHASE2/PHASE3

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

NCT00710034

Tobacco Use Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smokeless Tobacco Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

4 mg nicotine lozenges for 3 months

Group Type EXPERIMENTAL

Nicotine Lozenges

Intervention Type DRUG

Nicotine lozenges, 4 mg

B

Placebo nicotine lozenges for 3 months

Group Type PLACEBO_COMPARATOR

Placebo lozenge

Intervention Type DRUG

Placebo lozenge

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.