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Tobacco Cessation Via Doctors of Chiropractic
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), April 2006
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00386945
  Purpose

The purpose of the study is to develop an office-based tobacco intervention for chiropractic patients.


Condition Intervention
Tobacco Use Cessation
Behavioral: Brief counseling (Ask, Advise, Arrange)

Drug Information available for: Lobeline Lobeline sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Primary Outcome Measures:
  • To design and refine our brief office-based tobacco intervention to use within chiropractic settings.
  • To develop and refine study implementation protocols, DC and patient recruitment procedures, data collection strategies, and follow-up procedures.
  • Prepare a working Manual of Procedures for a future randomized clinical trial.

Secondary Outcome Measures:
  • Evaluate the reach of the intervention through an evaluation of the proportion of tobacco users of consenting age who give consent, the proportion who complete the baseline survey, and the reasons for not participating of those who decline.
  • Evaluate the adoption of the intervention by interviewing clinic staff to identify the organizational-level factors that are related to participation.
  • Assess the implementation of the intervention through an examination of patient report of receipt of the intervention components and change in providers’ behavior and attitudes as a function of training.
  • Explore the short-term maintenance of the intervention through an examination of change in provider behavior from baseline to 12 months after training and through an examination of change in clinic-level procedures.

Estimated Enrollment: 1530
Study Start Date: May 2006
Estimated Study Completion Date: February 2008
Detailed Description:

Medical doctors, nurses, dentists, and dental hygienists have been shown to be effective in helping their patients quit tobacco. However, Doctors of Chiropractic (DCs) have not been utilized in this role. DCs can provide a unique channel for the conduct of tobacco interventions, but they currently receive little to no training in these techniques (Hawk & Evans, 2005). Doctors of Chiropractic are increasingly concerned with patients’ use of cigarettes and smokeless tobacco. The chiropractic team provides educational and preventive services to patients, and the office visit can provide an extended opportunity to talk to patients about their tobacco use (Hawk, Long, Perillo, & Boulanger, 2004; Rupert, 2000). Given the health effects associated with chronic tobacco use, the chiropractic visit provides a “teachable moment” during which the DC can relate current health problems to tobacco use and provide brief counseling to patients who use tobacco (Gordon & Severson, 2001; Vogt, Lichtenstein, Ary, et al., 1989).

In the proposed developmental study, eight chiropractic clinics will participate in the design, implementation, and evaluation of an office-based tobacco cessation intervention. Adapted from previous office-based intervention protocols, the intervention will be based on Cognitive Learning Theory (Bandura, 1997) and the Clinical Practice Guidelines (Fiore, Bailey, Cohen, et al., 2000) and will also incorporate Motivational Interviewing techniques (Miller & Rollnick, 1991). Finally, using the RE-AIM framework (Glasgow, Vogt & Boles, 1999), we will assess individual-, clinic-, and organization-level variables that may affect the delivery of treatment for tobacco dependence, the implementation and maintenance of the intervention.

  Eligibility

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

Inclusion Criteria:

  • Doctors of Chiropractic currently licensed by the Oregon Board of Chiropractic Examiners and actively engaging in patient care, their Chiropractic Assistants, and their Chiropractic patients who use tobacco

Exclusion Criteria:

  • Chiropractic patients under the age of 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386945

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, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Principal Investigator: Judith S. Gordon, Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Judith S. Gordon, Ph.D. Oregon Research Institute
  More Information

Study ID Numbers: DA021349
Study First Received: September 19, 2006
Last Updated: October 10, 2006
ClinicalTrials.gov Identifier: NCT00386945  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Tobacco
Cessation.
Chiropractic patients.
Doctors of Chiropractic.
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