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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Nicotine Dependence

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Department of Family and Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Chih-Wen Shi, M.D., M.S., University of California, San Diego

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: August 23, 2005
• First Submitted That Met QC Criteria: August 23, 2005
• First Posted (Estimate): August 25, 2005

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: NIDA-15853-1; DPMC (Other Identifier: NIDA); K23-15853-1