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.|
|ClinicalTrials.gov Identifier: NCT00683839|
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : October 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: Brief tobacco counseling||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- The primary outcome is prolonged abstinence at 7.5 months following intervention. [ Time Frame: 7.5 months ]
- Reduction in tobacco use at 6 weeks and 7.5 months following intervention. [ Time Frame: 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 ]
- Increase in readiness to quit at 6 weeks & 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00683839
|United States, Mississippi|
|University of Mississippi|
|Jackson, Mississippi, United States, 39213|
|United States, New York|
|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|