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Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01689168
Recruitment Status : Terminated (Funding ran out)
First Posted : September 21, 2012
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
KevinRose, Southern California University of Health Sciences

Brief Summary:

Tobacco use is the number one killer of Americans today. Most current smokers have tried and failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and withdrawal from smoking can lead to physical symptoms such as irritability, anxiety, nervousness, depression and insomnia.

This study will examine the effects of tobacco cessation counseling and chiropractic treatments on smokers who desire to quit.


Condition or disease Intervention/treatment Phase
Smoking Behavioral: Counseling Procedure: Chiropractic adjustment Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial
Study Start Date : March 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Counseling plus chiropractic adjustments Behavioral: Counseling
Tobacco cessation counseling
Procedure: Chiropractic adjustment
Full spine high velocity, low amplitude manipulation of the spine
Active Comparator: Counseling alone Behavioral: Counseling
Tobacco cessation counseling



Primary Outcome Measures :
  1. Tobacco cessation [ Time Frame: Smoking diary will be complete for 3 months ]
    Has the subject quit smoking?

  2. Urinary cotinine [ Time Frame: Baseline, 14, 30, 60 and 90 days ]
    An urinary test for nicotine metabolites


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline, 14, 30, 60 days ]
  2. Weight [ Time Frame: Baseline, 14, 30, 60 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 18 yrs and above
  • Smokers with desire to quit smoking

Exclusion Criteria:

  • Received chiropractic treatment or other manipulative therapies within the last month
  • Have received any therapy for smoking cessation during the last month
  • Visceral, systemic or joint inflammatory disease
  • A history of low back surgery
  • Osteoporosis
  • Prolonged systemic corticosteroid medication
  • Pregnancy
  • Recent spinal fracture

Information from the National Library of Medicine

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): NCT01689168


Locations
United States, California
University Health Center - Whittier
Whittier, California, United States, 90604
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
Principal Investigator: Kevin A Rose, DC, MPH Southern California University of Health Sciences

Responsible Party: KevinRose, Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT01689168     History of Changes
Other Study ID Numbers: ROSE004
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015