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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00134927 |
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: | Cohort, Prospective |
| Official Title: | Usage Patterns of OTC Nicotine Patches: Consumer Survey |
| 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) |
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 |
600 consumers who purchased over-the-counter nicotine patches from a random sample of 30 retail pharmacies in San Diego County
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Department of Family and Preventive Medicine | |
| La Jolla, California, United States, 92093 | |
| 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 |
| Study First Received: | August 23, 2005 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00134927 History of Changes |
| Health Authority: | United States: Federal Government |
|
Nicotine polacrilex Nicotine Mental Disorders |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |
|
Mental Disorders Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |
