Effects of Marijuana Used on Lung Function in Persons Wit... | NCT01096303

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

NCT01096303

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

May 15, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

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 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Mar 24, 2010

First Submission Date that Met QC Criteria

Mar 30, 2010

First Posted Date

Mar 31, 2010Estimated

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 12, 2017

Last Update Posted Date

May 15, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosa Estrada Y Martin, Associate Professor - I/M Pulmonary and Critical Care, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD tobacco and/or marihuana users		COPD patients with history of tobacco and/or marihuana smoking.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obstructive limitation in pulmonary function test	Comparison on the severity of obstruction among both groups	1 year

Secondary Outcomes

Measure	Description	Time Frame
Decreased diffusion capacity for carbon monoxide	Comparison on the severity of decreased DLco among groups.	1 year
Airtrapping	Comparison on the severity of air-trapping by pulmonary function testing among groups.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

COPD patients recruited in pulmonary clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosa M Estrada-Y-Martin, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lyndon B Johnson General Hospital		Houston	Texas	77026	United States
The University of Texas- Health Science Center at Houston

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D008385	Marijuana Smoking

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided