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Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation

This study has been terminated.
(Funding ran out)
Sponsor:
Information provided by (Responsible Party):
KevinRose, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01689168
First received: June 5, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Smoking
Behavioral: Counseling
Procedure: Chiropractic adjustment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Southern California University of Health Sciences:

Primary Outcome Measures:
  • Tobacco cessation [ Time Frame: Smoking diary will be complete for 3 months ] [ Designated as safety issue: No ]
    Has the subject quit smoking?

  • Urinary cotinine [ Time Frame: Baseline, 14, 30, 60 and 90 days ] [ Designated as safety issue: No ]
    An urinary test for nicotine metabolites


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Baseline, 14, 30, 60 days ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: Baseline, 14, 30, 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: March 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: KevinRose, Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT01689168     History of Changes
Other Study ID Numbers: ROSE004
Study First Received: June 5, 2012
Last Updated: November 5, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 23, 2014