Tobacco Cessation Via Public Health Dental Clinics (PHD2)

October 24, 2011 updated by: Oregon Research Institute

Tobacco Cessation Via Public Health Dental Clinics (PHD2)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2637

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39213
        • University of Mississippi
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of participating public health dental clinics
  • Tobacco users

Exclusion Criteria:

  • Emergency patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is prolonged abstinence at 7.5 months following intervention.
Time Frame: 7.5 months
7.5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in tobacco use at 6 weeks and 7.5 months following intervention.
Time Frame: 6 weeks and 7.5 months
6 weeks and 7.5 months
Number of quit attempts at 6 weeks and 7.5 months following intervention.
Time Frame: 6 weeks & 7.5 months
6 weeks & 7.5 months
Increase in readiness to quit at 6 weeks & 7.5 months following intervention.
Time Frame: 6 weeks & 7.5 months
6 weeks & 7.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Collaborators

Columbia University
University of Mississippi Medical Center

Investigators

  • Principal Investigator: Judith S. Gordon, Ph.D, Oregon Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5R01CA107442-3
  • 5R01CA107442 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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