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OpenTrials
Completed

NCT Number: NCT00764439

Pilot Study of a New Nicotine Replacement Therapy

Pilot study of a new nicotine replacement therapy for smoking cessation.

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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

Phase 2

Primary location

Department of Primary Care and General Practice, University of Birmingham, Birmingham, United Kingdom

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About this study

This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.

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 Replacement Therapy

Drug

Nicotine replacement therapy with Standard NRT user direction

Other names: NRT

Primary outcomes

  1. Mean hourly and daily number of doses used

    Time frame: throughout study

Secondary outcomes

  1. Mean number of NRT use occasions per day

    Time frame: Week 1, 2, and 3

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

    Time frame: Day 1-14, and Day 20

  3. Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm

    Time frame: Day 1-21

  4. Cotinine levels

    Time frame: At baseline and week 3

  5. Product acceptability

    Time frame: At week 3 visit

  6. Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product.

    Time frame: throughout duration of the study (+ 30 days for spontaneous SAEs)

Sponsors and collaborators

Lead sponsor

McNeil AB

Industry

Registry information

Official study title

Pilot Study on Usage Patterns of a Novel Nicotine Replacement Therapy - A Multi-Center, Open, 3-Week Randomized Low Intervention Study of Two Different Directions for Use in Smokers Motivated to Quit

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2008
Registry last updated
Jul 10, 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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