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Sponsors and Collaborators: |
Oregon Research Institute Columbia University University of Mississippi Medical Center |
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Information provided by: | Oregon Research Institute |
ClinicalTrials.gov Identifier: | NCT00683839 |
The study will examine the effectiveness of public health dental practitioners using a brief office based intervention designed to help patients quit smoking or smokeless tobacco use, as compared to usual care.
Condition | Intervention | Phase |
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Smoking |
Behavioral: Brief tobacco counseling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Tobacco Cessation Via Public Health Dental Clinics (PHD2) |
Estimated Enrollment: | 2700 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Usual Care Control: Dental practitioners provide usual care.
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2: Experimental
Dental practitioners provide the following intervention: 5As plus nicotine replacement therapy The 5As consist of: Ask, Advise, Assess, Assist and Arrange. |
Behavioral: Brief tobacco counseling
Public health dental professionals provide brief counseling during routine visits based on the Clinical Practice Guidelines 5 As (Ask, Advise, Assess, Assist, Arrange), including offering free Nicotine Replacement Therapy and referral to a Tobacco Quit Line. Pharmacologic: nicotine patch or lozenge maximum 12 week course.
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The prevalence of tobacco use is especially high in lower socioeconomic status (SES) populations in the U.S. Community Health Centers provide comprehensive primary care services, and usually dental services, to large numbers of low-income smokers and smokeless tobacco users. The typical patient has multiple dental visits, which can be used for tobacco cessation advice and counseling by the dental office team. This study builds on a successful pilot study conducted in two public health dental clinics.
This study is a randomized clinical trial in which 14 public health dental clinics in Oregon, Mississippi, and New York City were stratified by state, matched within state by racial/ethnic composition, and then randomly assigned to either the Intervention or Usual Care Control condition. In the Intervention Condition, the dental team provided a brief intervention modeled on the "5A's" advocated by the Clinical Practice Guideline.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Mississippi | |
University of Mississippi | |
Jackson, Mississippi, United States, 39213 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Oregon | |
Oregon Research Institute | |
Eugene, Oregon, United States, 97403 |
Principal Investigator: | Judith S. Gordon, Ph.D | Oregon Research Institute |
Responsible Party: | Oregon Research Institute ( Judith S. Gordon, Ph.D. Senior Scientist ) |
Study ID Numbers: | 5R01CA107442-3 |
Study First Received: | May 16, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00683839 |
Health Authority: | United States: Institutional Review Board |
Tobacco Smoking Smokeless Cessation Public health clinic |
Dental patients 5 As NRT Tobacco Quit Line Smokeless tobacco |
Nicotine polacrilex Smoking Lobeline Nicotine |
Habits |