Chronic Obstructive Pulmonary DiseaseNCT01096303
Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients recruited in pulmonary clinic.
Who may be able to join
- COPD patients former or current tobacco smokers
- COPD patients former or current tobacco and marihuana smokers
Who cannot join
- History of COPD without pulmonary function testing
- Refusal to provide smoking or marihuana used history
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B Johnson General Hospital
Houston, Texas, 77026
The University of Texas- Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Effects of Marijuana Smoking on Pulmonary Function in Patients With COPD
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, pulmonary function, tobacco and marihuana smoking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Marijuana Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD tobacco and/or marihuana users | COPD patients with history of tobacco and/or marihuana smoking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive limitation in pulmonary function test
Comparison on the severity of obstruction among both groups
Measured: 1 year
Secondary outcomes (2)
Decreased diffusion capacity for carbon monoxide
Comparison on the severity of decreased DLco among groups.
Measured: 1 year
Airtrapping
Comparison on the severity of air-trapping by pulmonary function testing among groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startNov 2010
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Estrada Y Martin, The University of Texas Health Science Center, Houston
- Investigators
- Rosa M Estrada-Y-Martin, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096303
- Sponsor's protocol ID
- HSC-MS-09-0362
- Status last verified
- May 2017
- First submitted
- 24 Mar 2010
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Marijuana Smoking on Pulmonary Function in Patients With COPD
- ClinicalTrials.gov ID
- NCT01096303
- Acronym / sponsor ID
- HSC-MS-09-0362
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, pulmonary function, tobacco and marihuana smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD tobacco and/or marihuana users | – | –COPD patients with history of tobacco and/or marihuana smoking. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients recruited in pulmonary clinic.
Key inclusion criteria (2 listed)
- COPD patients former or current tobacco smokers
- COPD patients former or current tobacco and marihuana smokers
Key exclusion criteria (2 listed)
- History of COPD without pulmonary function testing
- Refusal to provide smoking or marihuana used history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obstructive limitation in pulmonary function test
Time frame: 1 year
Comparison on the severity of obstruction among both groups
2 secondary outcomes
Decreased diffusion capacity for carbon monoxide
Time frame: 1 year
Airtrapping
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M Estrada-Y-Martin, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive limitation in pulmonary function test (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.