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Tobacco Cessation Via Public Health Dental Clinics (PHD2)

This study has been completed.
Sponsor:
Collaborators:
Columbia University
University of Mississippi Medical Center
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00683839
First received: May 16, 2008
Last updated: October 24, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Smoking
 Behavioral: Brief tobacco counseling
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tobacco Cessation Via Public Health Dental Clinics (PHD2)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • The primary outcome is prolonged abstinence at 7.5 months following intervention. [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in tobacco use at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks and 7.5 months ] [ Designated as safety issue: No ]
  • Number of quit attempts at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ] [ Designated as safety issue: No ]
  • Increase in readiness to quit at 6 weeks & 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ] [ Designated as safety issue: No ]

Enrollment: 2637
Study Start Date: January 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of participating public health dental clinics
  • Tobacco users

Exclusion Criteria:

  • Emergency patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683839

Locations
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
Investigators
Principal Investigator: Judith S. Gordon, Ph.D Oregon Research Institute
  More Information

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
ClinicalTrials.gov Identifier: NCT00683839     History of Changes
Other Study ID Numbers: 5R01CA107442-3
Study First Received: May 16, 2008
Last Updated: October 24, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 19, 2013