NCT00134927

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

January 10, 2017

Status Verified

October 1, 2008

Enrollment Period

8 months

First QC Date

August 23, 2005

Last Update Submit

January 9, 2017

Conditions

Nicotine DependenceTobacco Use Disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Purchased OTC nicotine patch (NicoDerm CQ Step I, II, III or Sav-on Nicotine Patch) for personal use

You may not qualify if:

  • Purchased OTC nicotine patch for someone other than self (e.g., friend or family member)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family and Preventive Medicine

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Chih-Wen Shi, M.D., M.S.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

September 1, 2005

Primary Completion

May 1, 2006

Study Completion

November 1, 2006

Last Updated

January 10, 2017

Record last verified: 2008-10

Locations

US(1)