Neoplasms
Conditions
Keywords
Cancer pain, All types of cancer except lung cancer
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.
Interventions
DRUGSmoked Marijuana
Sponsors
University of California, San Francisco
Center for Medicinal Cannabis Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in level of cancer pain as recorded on a 100mm Visual Analog Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed