Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home. Approximately 1500 subjects will be enrolled into the study. The study will require participants to use the treatment for 12 weeks and there will be a 14-week follow-up period. The study will be conducted in approximately 20 pharmacies across the United States.

At the first visit to the pharmacy, participants will be asked some questions to see if they are eligible to participate. Participants will be asked to sign a consent form if they agree to participate. Participants will answer some more questions, and blow into a machine to measure their carbon monoxide (CO) levels to make sure they qualify for the trial. Participants will be asked to go to a nearby dentist who will look at their mouths. Participants will go back to the pharmacy and if they qualify, they will be given a supply of their assigned treatment. They will have an equal chance of receiving a treatment that has a drug in it or one that has no drug in it. They will be given a diary to keep track of how much of the treatment they use.

Subjects will go to the pharmacy four more times to hand in their diaries and blow into a machine that will measure their CO levels. At the last visit, subjects will have their mouths examined by a dentist again to have their mouth checked.

Subjects will receive four telephone calls during the study where they will be asked some questions.

After the 12 week treatment period, subjects will receive two to three more telephone calls, where they will be asked to answer some questions. Participants may be asked to come back to the pharmacy two more times to blow into the carbon monoxide machine again.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Collaborators: GlaxoSmithKline; McNeil AB
• Treatments: Nicotine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects must not have a recent history of unstable angina, myocardial infarction or stroke

• They must not have a suspected malignant and/or erosive oral lesion