NeoplasmsPhase 1/2NCT00046709
Marijuana for Cancer Pain
A Phase 1/2 study testing Smoked Marijuana in people with Neoplasms, run by Center for Medicinal Cannabis Research at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Smoked Marijuana
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Oct 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Have severe heart disease, uncontrolled hypertension, or lung disease.
- Currently be receiving treatment with corticosteroids.
- Be pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- Smoked Marijuana
- Keywords
- Cancer pain, All types of cancer except lung cancer
- Medical subject headings
- Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked MarijuanaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.
Secondary outcomes (3)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2002 (estimated)
- Study startSep 2002
- Study completionOct 2004
Why it stopped: Discontinued due to non-enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- Center for Medicinal Cannabis Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Investigators
- Donald I Abrams, M.D., Principal investigator, UCSF Community Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046709
- Sponsor's protocol ID
- C00-SF-108
- Other IDs
- CC#057
- Status last verified
- Oct 2013
- First submitted
- 1 Oct 2002
- Last updated
- 10 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana in Combination With Opioids for Cancer Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT00046709
- Acronym / sponsor ID
- C00-SF-108
- Conditions
- Neoplasms
- Keywords
- Cancer pain, All types of cancer except lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued due to non-enrollment.
- Enrolment
- 16 participants
- Lead sponsor
- Center for Medicinal Cannabis ResearchUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Sep 2002
- Study completion
- Oct 2004 (actual)
- First posted
- 2 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoked Marijuana | Drug | – |
Primary outcome
Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.
3 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: Discontinued due to non-enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Center for Medicinal Cannabis ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald I Abrams, M.D. principal investigator
UCSF Community Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Smoked Marijuana in people with Neoplasms, run by Center for Medicinal Cannabis Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Discontinued due to non-enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013.