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

NCT01296698 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2012-04-23

Study results available
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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.

Conditions

  • Tobacco Dependence

Interventions

DRUG

Placebo

Dosage Form: Oral NRT; Dose: 0 mg; Frequency: up to 4 times per hour; Duration: 12 weeks

DRUG

Nicotine

Dosage Form: Oral NRT; Dose: 1 mg;Frequency: up to four times per hour; Duration:12 weeks

Sponsors & Collaborators

  • McNeil AB

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Qi, MD · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01296698 on ClinicalTrials.gov