Tobacco Cessation Via Public Health Dental Clinics (PHD2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683839
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : October 26, 2011
Columbia University
University of Mississippi Medical Center
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Behavioral: Brief tobacco counseling Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobacco Cessation Via Public Health Dental Clinics (PHD2)
Study Start Date : January 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 2

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.

No Intervention: 1
Usual Care Control: Patients receive treatment as usual.

Primary Outcome Measures :
  1. The primary outcome is prolonged abstinence at 7.5 months following intervention. [ Time Frame: 7.5 months ]

Secondary Outcome Measures :
  1. Reduction in tobacco use at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks and 7.5 months ]
  2. Number of quit attempts at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ]
  3. Increase in readiness to quit at 6 weeks & 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients of participating public health dental clinics
  • Tobacco users

Exclusion Criteria:

  • Emergency patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683839

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
Sponsors and Collaborators
Oregon Research Institute
Columbia University
University of Mississippi Medical Center
Principal Investigator: Judith S. Gordon, Ph.D Oregon Research Institute

Publications of Results:
Other Publications:
Hinds E, Gordon JS, Widdop CJ. Tobacco Cessation in Public Health Dental Clinics: Short-Term Outcomes for Women. Society of Behavioral Medicine's 29th Annual Meeting and Scientific Sessions in San Diego, California, March 26-29th, 2008.

Responsible Party: Oregon Research Institute Identifier: NCT00683839     History of Changes
Other Study ID Numbers: 5R01CA107442-3
5R01CA107442 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Keywords provided by Oregon Research Institute:
Public health clinic
Dental patients
5 As
Tobacco Quit Line
Smokeless tobacco