Marijuana for Cancer Pain

Neoplasms Clinical Trial

Official title:

Marijuana in Combination With Opioids for Cancer Pain: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00046709
• Other study ID #: C00-SF-108
• Secondary ID: CC#057
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 1, 2002
• Last updated: October 9, 2013
• Start date: September 2002
• Est. completion date: October 2004

Study information

• Verified date: October 2013
• Source: Center for Medicinal Cannabis Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00052871

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Smoked Marijuana

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Center for Medicinal Cannabis Research	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.
Secondary	Change in level of experimentally induced pain on a 100mm Visual Analog Scale.
Secondary	Change in nausea and emesis in participants exhibiting these symptoms.
Secondary	Change in disposition kinetics of opioid analgesics.

External Links

•   Center for Medicinal Cannabis Research