Marijuana for Cancer Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

October 1, 2002

Last Updated Date

April 3, 2007

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00046709 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Marijuana for Cancer Pain

Official Title ^ICMJE

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

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Neoplasms

Intervention ^ICMJE

Drug: Smoked Marijuana

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00046709

Responsible Party

Study ID Numbers ^ICMJE

C00-SF-108, CC#057

Study Sponsor ^ICMJE

Center for Medicinal Cannabis Research

Collaborators ^ICMJE

University of California, San Francisco

Investigators ^ICMJE

Principal Investigator:

Donald I Abrams, M.D.

UCSF Community Consortium

Information Provided By

Center for Medicinal Cannabis Research

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP