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

Nicotine Dependence Clinical Trial

Official title:

Usage Patterns of OTC Nicotine Patches: Consumer Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134927
• Other study ID #: NIDA-15853-1
• Secondary ID: K23-15853-1DPMC
• Status: Completed
• Phase: N/A
• First received: August 23, 2005
• Last updated: January 9, 2017
• Start date: September 2005
• Est. completion date: November 2006

Study information

• Verified date: October 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Locations

Country	Name	City	State
United States	Department of Family and Preventive Medicine	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States,