Back to resultsMarijuana for Cancer Pain
Primary Purpose
Neoplasms
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smoked Marijuana
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Cancer pain, All types of cancer except lung cancer
Eligibility 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.
Sites / Locations
- University of California, San Francisco
Outcomes
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.
Full Information
NCT ID
NCT00046709
First Posted
October 1, 2002
Last Updated
October 9, 2013
Sponsor
Center for Medicinal Cannabis Research
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00046709
Brief Title
Marijuana for Cancer Pain
Official Title
Marijuana in Combination With Opioids for Cancer Pain: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Discontinued due to non-enrollment.
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Center for Medicinal Cannabis Research
Collaborators
University of California, San Francisco
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Cancer pain, All types of cancer except lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Smoked Marijuana
Primary Outcome Measure Information:
Title
Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.
Secondary Outcome Measure Information:
Title
Change in level of experimentally induced pain on a 100mm Visual Analog Scale.
Title
Change in nausea and emesis in participants exhibiting these symptoms.
Title
Change in disposition kinetics of opioid analgesics.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald I Abrams, M.D.
Organizational Affiliation
UCSF Community Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cmcr.ucsd.edu
Description
Center for Medicinal Cannabis Research
Learn more about this trial
Marijuana for Cancer Pain
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