Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation

May 18, 2015 updated by: KevinRose, Southern California University of Health Sciences

Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Whittier, California, United States, 90604
        • University Health Center - Whittier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tobacco cessation
Time Frame: Smoking diary will be complete for 3 months
Has the subject quit smoking?
Smoking diary will be complete for 3 months
Urinary cotinine
Time Frame: Baseline, 14, 30, 60 and 90 days
An urinary test for nicotine metabolites
Baseline, 14, 30, 60 and 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: Baseline, 14, 30, 60 days
Baseline, 14, 30, 60 days
Weight
Time Frame: Baseline, 14, 30, 60 days
Baseline, 14, 30, 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California University of Health Sciences

Investigators

  • Principal Investigator: Kevin A Rose, DC, MPH, Southern California University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • ROSE004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe