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

Completed

• Conditions: Nicotine Dependence; Tobacco Use Disorder

• Registration Number: NCT00134927
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-25
• Study Start: 2005-09
• Primary Completion: 2006-05
• Study Completion: 2006-11
• Status Verified: 2008-10
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Family and Preventive Medicine; 🇺🇸 La Jolla, California, United States