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OpenTrials
Completed

NCT Number: NCT00882375

Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte University Hospital, Hellerup, Denmark

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About this study

Efficacy and safety study following use of a novel nicotine replacement therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older male and female cigarette smokers motivated and willing to stop smoking
  • Female participants of child-bearing potential should use a medically acceptable means of birth control.
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion criteria

  • Unstable angina pectoris or myocardial infarction during the previous 3 months.
  • Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
  • Participation in other clinical trials within the previous three months and during study participation.

Treatment and study plan

nicotine

Drug

Nicotine administered using novel NRT user instructions

Other names: NRT

Placebo

Drug

Placebo administered using novel NRT user instructions

Primary outcomes

  1. Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.

    Time frame: at weeks 2, 6, 24 and 52

Secondary outcomes

  1. Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.

    Time frame: weeks 2, 4, 8, 12, 16, and 20

  2. Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.

    Time frame: weeks 4, 6, 8, 12, 16, 20, 24, and 52

  3. Ratings of craving/urge to smoke and withdrawal symptoms.

    Time frame: baseline to 24 weeks

  4. Cotinine levels in saliva.

    Time frame: baseline, and weeks 2, 6, 12 and 24

  5. Product acceptability

    Time frame: weeks 1, 6 and 12

Sponsors and collaborators

Lead sponsor

McNeil AB

Industry

Registry information

Official study title

Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2009
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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