NCT01689168

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

June 5, 2012

Last Update Submit

May 18, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Blood pressure

    Baseline, 14, 30, 60 days

  • Weight

    Baseline, 14, 30, 60 days

Study Arms (2)

Counseling plus chiropractic adjustments

EXPERIMENTAL
Behavioral: CounselingProcedure: Chiropractic adjustment

Counseling alone

ACTIVE COMPARATOR
Behavioral: Counseling

Interventions

CounselingBEHAVIORAL

Tobacco cessation counseling

Counseling aloneCounseling plus chiropractic adjustments

Full spine high velocity, low amplitude manipulation of the spine

Counseling plus chiropractic adjustments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Center - Whittier

Whittier, California, 90604, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

CounselingManipulation, Chiropractic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMusculoskeletal ManipulationsComplementary TherapiesTherapeutics

Study Officials

  • Kevin A Rose, DC, MPH

    Southern California University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2012

First Posted

September 21, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations