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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01689168
Other study ID # ROSE004
Secondary ID
Status Terminated
Phase Phase 1
First received June 5, 2012
Last updated May 18, 2015
Start date March 2012
Est. completion date May 2014

Study information

Verified date May 2015
Source Southern California University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date May 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Counseling
Tobacco cessation counseling
Procedure:
Chiropractic adjustment
Full spine high velocity, low amplitude manipulation of the spine

Locations

Country Name City State
United States University Health Center - Whittier Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Southern California University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tobacco cessation Has the subject quit smoking? Smoking diary will be complete for 3 months No
Primary Urinary cotinine An urinary test for nicotine metabolites Baseline, 14, 30, 60 and 90 days No
Secondary Blood pressure Baseline, 14, 30, 60 days No
Secondary Weight Baseline, 14, 30, 60 days No
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