Marijuana for Cancer Pain

October 9, 2013 updated by: Center for Medicinal Cannabis Research

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Medicinal Cannabis Research

Collaborators

University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

October 1, 2002

First Submitted That Met QC Criteria

October 1, 2002

First Posted (Estimate)

October 2, 2002

Study Record Updates

Last Update Posted (Estimate)

October 10, 2013

Last Update Submitted That Met QC Criteria

October 9, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C00-SF-108
  • CC#057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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