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Completed

NCT Number: NCT00683839

Tobacco Cessation Via Public Health Dental Clinics

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.

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Key information

Conditions

Smoking Behavior Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Mississippi, Jackson, Mississippi, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of participating public health dental clinics
  • Tobacco users

Exclusion criteria

  • Emergency patients

Treatment and study plan

Brief tobacco counseling

Behavioral

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.

Primary outcomes

  1. The primary outcome is prolonged abstinence at 7.5 months following intervention.

    Time frame: 7.5 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • Columbia University
  • University of Mississippi Medical Center

Registry information

Official study title

Tobacco Cessation Via Public Health Dental Clinics (PHD2)

Acronym: PHD2

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 26, 2008
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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