Marijuana for Cancer Pain | NCT00046709

Studies
Marijuana for Cancer Pain

NCT00046709

Sponsor

Center for Medicinal Cannabis Research

Status

Terminated

Last Update Posted

Oct 10, 2013Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Neoplasms

Interventions

Smoked Marijuana

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CC#057

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Discontinued due to non-enrollment.

Expanded Access Info

Not provided

Start Date

Sep 2002

Primary Completion Date

Not provided

Completion Date

Oct 2004Actual

First Submitted Date

Oct 1, 2002

First Submission Date that Met QC Criteria

Oct 1, 2002

First Posted Date

Oct 2, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2013

Last Update Posted Date

Oct 10, 2013Estimated

Name	Class
University of California, San Francisco	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Smoked Marijuana	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald I Abrams, M.D.	UCSF Community Consortium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94110	United States

Label	URL
Center for Medicinal Cannabis Research	View source

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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