Chiropractic Treatment With Counseling Versus Counseling... | NCT01689168

Studies
Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation

NCT01689168

Sponsor

Southern California University of Health Sciences

Status

Terminated

Last Update Posted

May 20, 2015Estimated

Enrollment

19Actual

Phase

Phase 1

Conditions

Smoking

Interventions

Counseling
Chiropractic adjustment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding ran out

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Jun 5, 2012

First Submission Date that Met QC Criteria

Sep 20, 2012

First Posted Date

Sep 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2015

Last Update Posted Date

May 20, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

KevinRose, Professor, Southern California University of Health SciencesPrincipal Investigator

Lead Sponsor

Southern California University of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Counseling plus chiropractic adjustments	Experimental		Behavioral: Counseling Procedure: Chiropractic adjustment
Counseling alone	Active Comparator		Behavioral: Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Counseling	Behavioral	Tobacco cessation counseling	Counseling alone Counseling plus chiropractic adjustments

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin A Rose, DC, MPH	Southern California University of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Center - Whittier		Whittier	California	90604	United States

ID	Term
D012907	Smoking

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D003376	Counseling
D026882	Manipulation, Chiropractic

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided