Marijuana for Cancer Pain

This study has been terminated.

( Discontinued due to non-enrollment. )

First Received: October 1, 2002 Last Updated: April 3, 2007 History of Changes

Sponsors and Collaborators:	Center for Medicinal Cannabis Research University of California, San Francisco
Information provided by:	Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:	NCT00046709

Purpose

To find out if it is safe and effective to use smoked marijuana in combination with opioids to treat cancer pain. The study will evaluate whether smoked marijuana, when used with opioids, will have an effect on pain relief, and to see if marijuana reduces the side effects of opioids, which include nausea and/or vomiting.

Condition	Intervention	Phase
Neoplasms	Drug: Smoked Marijuana	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Marijuana in Combination With Opioids for Cancer Pain: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Marijuana Nausea and Vomiting

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:

Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.

Secondary Outcome Measures:

Change in level of experimentally induced pain on a 100mm Visual Analog Scale.
Change in nausea and emesis in participants exhibiting these symptoms.
Change in disposition kinetics of opioid analgesics.

Estimated Enrollment:	16
Study Start Date:	September 2002
Study Completion Date:	October 2004

Detailed Description:

To take part in this study, you must have ongoing cancer pain which is currently being treated with opioids. If you meet all the eligibility criteria you will be admitted to the General Clinical Research Center at San Francisco General Hospital for 9 days. The treatment consists of smoking one marijuana cigarette 3 times a day.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA

Have ongoing cancer pain
Be diagnosed with cancer and have at least a six month survival.
Be on a stable dose of opioid medication for at least 2 weeks before enrollment.
Have smoked marijuana on at least 6 occasions in their lifetime prior to enrollment.

EXCLUSION CRITERIA

You must not:

Start chemotherapy, radiation or biphosphonates during the study, or have received any new intervention with any such agents within the past 4 weeks.
Currently be using smoked tobacco products.
Currently be in methadone treatment.
Have smoked marijuana within 30 days of enrollment.
Be diagnosed with diabetes mellitus.
Have severe heart disease, uncontrolled hypertension, or lung disease.
Currently be receiving treatment with corticosteroids.
Be pregnant or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046709

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94110

Sponsors and Collaborators

Center for Medicinal Cannabis Research

University of California, San Francisco

Investigators

Principal Investigator:

Donald I Abrams, M.D.

UCSF Community Consortium

More Information

Additional Information:

Community Consortium Web Page This link exits the ClinicalTrials.gov site

Center for Medicinal Cannabis Research This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	C00-SF-108, CC#057
Study First Received:	October 1, 2002
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00046709 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:

Cancer pain
All types of cancer except lung cancer

Study placed in the following topic categories:

Lung Neoplasms
Pain
Marijuana Abuse

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009