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
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usage Patterns of OTC Nicotine Patches: Consumer Survey

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014