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Tobacco Quitlines:Adjunct to Dental Office Tobacco Intervention
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), October 2006
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00384254
  Purpose

The purpose of the study is to compare two methods for providing brief dental office-based interventions designed to help patients quit either cigarette smoking or smokeless tobacco use, and to compare these two dental office-based interventions with usual care. This trial will evaluate the effectiveness of a unique combination of dental office intervention plus referral to the telephone help line, both of which have been demonstrated to be effective interventions for tobacco cessation. The integration of two lines of research—dental office interventions and telephone help line effectiveness—led us to propose this clinical trial as a more efficient and disseminable model of both training and practice.


Condition Intervention
Tobacco Use Cessation
Behavioral: Brief counseling: 5As compared to 3As

MedlinePlus related topics: Smoking
Drug Information available for: Lobeline Lobeline sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Tobacco Quitlines as an Adjunct to Dental Office Tobacco Intervention

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention.
  • Secondary outcomes are reduction in use, number of quit attempts at 3 and 12 months, and increases in readiness to quit.

Secondary Outcome Measures:
  • Conduct an economic analysis to determine the incremental cost per quit of the two interventions.
  • Examine predictors of patient outcomes and the interaction of these variables with intervention condition.
  • Examine patients’ report of practitioner protocol delivery at six weeks as a function of intervention condition.
  • Examine the mediating effect of patient report of protocol delivery on patient outcomes across conditions.
  • Assess practitioner report of implementation (at 3 months) and maintenance (at 12 months) of the protocol.
  • Assess the effect of the intervention condition on changes in self-reported attitudes of dentists, dental hygienists, and dental assistants.

Estimated Enrollment: 4100
Study Start Date: January 2004
Estimated Study Completion Date: October 2007
Detailed Description:

Although many dental practitioners now routinely incorporate the first two of the “5A’s” (Ask and Advise) into their practice, and previous research indicates that brief office-based interventions are effective in producing modest tobacco quit rates for dental patients, dental practitioners continue to perceive a number of obstacles to routine provision of tobacco cessation services. Many dental practitioners still believe that counseling patients to quit an addictive behavior is beyond the scope of their training or comfort.

Recent studies have shown that proactive phone counseling from State-sponsored telephone tobacco help lines has a positive effect on tobacco cessation. The use of these help lines offers a unique supplement to the dental professional that could reduce the burden on practitioner and enhance the likelihood of their patients’ quitting. Referral to a specialist is within the common heuristic followed by dental and medical practitioners. Therefore, we believe referral to a telephone help line may be an innovative way of enabling dentists and dental hygienists to encourage and support their patients to quit tobacco.

We will test two levels of intervention as compared to usual care in a randomized clinical trial in which 60 dental practices in Mississippi are randomized to one of three conditions. In one condition (“5A’s”), the dental team will provide a brief office-based intervention that is modeled on the “5A’s” advocated by the Clinical Practice Guideline. In the second condition (“3A’s” + THL), the dental team will provide the first three “A’s” (Ask, Advise, Assess), and then refer patients to the State-supported telephone help line for provision of the cessation counseling and follow-up support. In the third condition (Usual Care), volunteering practices will ask their patients only to complete our study surveys.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult tobacco-using dental patients, aged 18 and older who come in for a regularly scheduled visit to a dentist or dental hygienist participating in our study.
  • Dentists in private practice, employing at least one dental hygienist and one dental assistant.

Exclusion Criteria:

  • Dental patients under the age of 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384254

Contacts
Contact: Judith S. Gordon, Ph.D 541-484-2123 ext 2212 judith@ori.org
Contact: Julia E. Martin, BA 541-484-2123 ext 2205 juliam@ori.org

Locations
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39213
Contact: Karen M. Crews, D.M.D.     601-815-1180     kcrews@sod.umsmed.edu    
Contact: Thomas J. Payne, Ph.D     601-815-1180     tjpayne@sod.umsmed.edu    
Principal Investigator: Karen M. Crews, D.M.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Judith S. Gordon, Ph.D Oregon Research Institute
  More Information

Study ID Numbers: DA 17972
Study First Received: October 3, 2006
Last Updated: October 3, 2006
ClinicalTrials.gov Identifier: NCT00384254  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Tobacco.
Cessation.
Dental patients.
Dentists.
Hygienists.
Dental assistants.
Health care providers.
Behavioral intervention.
Tobacco intervention.
Cigarettes.
Smokeless tobacco.
Smoking intervention.

Study placed in the following topic categories:
Smoking
Lobeline

ClinicalTrials.gov processed this record on January 16, 2009