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Effects of Marihuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)

This study is currently recruiting participants.
Verified May 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Rosa Estrada Y Martin, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01096303
First received: March 24, 2010
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effects of Marihuana Smoking on Pulmonary Function in Patients With COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Obstructive limitation in pulmonary function test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparison on the severity of obstruction among both groups


Secondary Outcome Measures:
  • Decreased diffusion capacity for carbon monoxide [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparison on the severity of decreased DLco among groups.

  • Airtrapping [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparison on the severity of air-trapping by pulmonary function testing among groups.


Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD tobacco and/or marihuana users
COPD patients with history of tobacco and/or marihuana smoking.

Detailed Description:

We will follow persons with already diagnosed COPD (chronic bronchitis and/or emphysema). Obtain their smoking history: tobacco and marihuana and review their pulmonary function study results. Then we are planning to compare both groups.

  Eligibility

Ages Eligible for Study:   25 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

COPD patients recruited in pulmonary clinic.

Criteria

Inclusion Criteria:

  • COPD patients former or current tobacco smokers
  • COPD patients former or current tobacco and marihuana smokers

Exclusion Criteria:

  • History of COPD without pulmonary function testing
  • Refusal to provide smoking or marihuana used history
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096303

Contacts
Contact: Rosa M Estrada-Y-Martin, MD 713-500-6828 rosa.m.estrada.y.martin@uth.tmc.edu

Locations
United States, Texas
Lyndon B Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
The University of Texas- Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Rosa M Estrada-Y-Martin, MD     713-500-6830     rosa.m.estrada.y.martin@uth.tmc.edu    
Principal Investigator: Rosa M Estrada-Y-Martin, MD            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Rosa M Estrada-Y-Martin, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Rosa Estrada Y Martin, Associate Professor - I/M Pulmonary and Critical Care, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01096303     History of Changes
Other Study ID Numbers: HSC-MS-09-0362
Study First Received: March 24, 2010
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
COPD
pulmonary function
tobacco and marihuana smoking

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Marijuana Abuse
Marijuana Smoking
Lung Diseases, Obstructive
 Respiratory Tract Diseases
Substance-Related Disorders
Mental Disorders
Smoking
Habits

ClinicalTrials.gov processed this record on June 18, 2013