Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Tobacco Dependence

In brief

The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.

Key facts

Study ID

NCT02355665

Run by

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

People needed

1198

Starts

2015-01-31

Expected to finish

2016-02-10

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking

You may not qualify if…

• History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.
• Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.
• Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.
• Pregnancy or intending to become pregnant.
• Hypersensitivity to the product, history of alcohol or substance abuse.

Where it is running

• Radiant Research, Inc — Dallas, Texas, United States
• Radiant Research, Inc — Salt Lake City, Utah, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Los Angeles Clinical Trials — Burbank, California, United States
• Radiant Research, Inc — Chicago, Illinois, United States
• University of Maryland — College Park, Maryland, United States
• Radiant Research, Inc. — Akron, Ohio, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.