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

Purpose

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.

Condition

Nicotine Dependence
Tobacco Use Disorder

MedlinePlus related topics:

Over-the-Counter Medicines

ChemIDplus related topics:

Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Usage Patterns of OTC Nicotine Patches: Consumer Survey

Further study details as provided by National Institute on Drug Abuse (NIDA):

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	600
Study Start Date:	September 2005
Study Completion Date:	November 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134927

Locations


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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Chih-Wen Shi, M.D., M.S.	University of California, San Diego

More Information

Responsible Party:	University California, San Diego ( Chih-Wen Shi, MD )
Study ID Numbers:	NIDA-15853-1, K23-15853-1, DPMC
First Received:	August 23, 2005
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00134927
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Nicotine polacrilex

Nicotine

Mental Disorders

Tobacco Use Disorder

Substance-Related Disorders

Disorders of Environmental Origin

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00134927