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A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00134927
First received: August 23, 2005
Last updated: October 2, 2008
Last verified: October 2008

August 23, 2005
October 2, 2008
September 2005
May 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00134927 on ClinicalTrials.gov Archive Site
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A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches
Usage Patterns of OTC Nicotine Patches: Consumer Survey

Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Little is known about how the public uses the OTC nicotine patch due to lack of monitoring. The purpose of this observational study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with the appropriate use of nicotine patches.

The nicotine patch is an effective aid for smoking cessation. Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Unlike prescription medications, post-marketing surveillance does not exist for OTC medications. The purpose of this study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with appropriate use of nicotine patches.

This prospective, cross-sectional, observational study will include a survey of 600 consumers who purchase OTC nicotine patches at a random sample of 30 community retail pharmacies. Consumers will be recruited by an ad located in the pharmacy next to the nicotine patch product. Participants will fill out a self-administered, anonymous questionnaire at the time of OTC nicotine patch purchase at the pharmacy counter. The questionnaire will gather information about demographics, medical history, smoking history, attitudes toward the nicotine patch, and motivation to quit smoking. No study visits will be required for this study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

600 consumers who purchased over-the-counter nicotine patches from a random sample of 30 retail pharmacies in San Diego County

  • Nicotine Dependence
  • Tobacco Use Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
November 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Purchased OTC nicotine patch (NicoDerm CQ Step I, II, III or Sav-on Nicotine Patch) for personal use

Exclusion Criteria:

  • Purchased OTC nicotine patch for someone other than self (e.g., friend or family member)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00134927
NIDA-15853-1, K23-15853-1, DPMC
Yes
Chih-Wen Shi, MD, University California, San Diego
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Chih-Wen Shi, M.D., M.S. University of California, San Diego
National Institute on Drug Abuse (NIDA)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP