Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation

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: Smoking
• Intervention / Treatment: Behavioral: Counseling; Procedure: Chiropractic adjustment

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Has the subject quit smoking?	Smoking diary will be complete for 3 months
Urinary cotinine	An urinary test for nicotine metabolites	Baseline, 14, 30, 60 and 90 days

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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