Peripheral Nervous System DiseasesPhase 1/2NCT00046722
Marijuana for HIV-Related Peripheral Neuropathy
A Phase 1/2 study testing Smoked Marijuana in people with Peripheral Nervous System Diseases and HIV Infections, run by Center for Medicinal Cannabis Research at 1 site in United States.
Trial summary
To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nervous System Diseases, HIV Infections
- What is being tested?
- Smoked Marijuana
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Apr 2005
- 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
- HIV positive.
- Be 18 years or older.
- Diagnosis of HIV-related painful neuropathy.
- Stable antiretroviral therapy or no antiretroviral therapy for at least 8 weeks.
- Prior use of marijuana, at least 6 occasions in their lifetime prior to enrollment.
Who cannot join
- Current use of smoked tobacco products.
- Current methadone treatment.
- Use of smoked marijuana within 30 days of enrollment.
- Diagnosis of diabetes mellitus.
- Currently receiving treatment with corticosteroids.
- Use of INH, dapsone or metronidazole within 8 weeks prior to enrollment.
- Severe heart disease, uncontrolled high blood pressure or lung disease.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco Community Consortium
San Francisco, California, 94110
About this study
Official title: Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.
To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.
Read the detailed description
The study will include subjects with peripheral neuropathy caused either by HIV-disease or antiretroviral medication for the treatment of HIV. A neurologist will conduct a neurological and pain evaluation to determine eligibility for the study. Subjects who meet all eligibility criteria will be admitted to the General Clinical Research Center at San Francisco General Hospital for seven days. Subjects will be randomized (like a toss of a coin) to smoke marijuana or a placebo (cigarettes with no THC).
- Conditions
- Peripheral Nervous System Diseases, HIV Infections
- Being tested
- Smoked Marijuana
- Keywords
- treatment experienced, complementary therapies, Neuropathy, Peripheral Neuropathy, HIV-Related Peripheral Neuropathy, HIV
- Medical subject headings
- Peripheral Nervous System Diseases, HIV Infections
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 HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
Secondary outcomes (1)
Change in level of experimentally-induced pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2002 (estimated)
- Study startJan 2003
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nervous System DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Center for Medicinal Cannabis Research
- Sponsor type
- University, hospital or other
- Investigators
- Donald I Abrams, M.D., Principal investigator, UCSF Community Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046722
- Sponsor's protocol ID
- C00-SF-101
- Other IDs
- CC# 056
- Status last verified
- Jun 2007
- First submitted
- 1 Oct 2002
- Last updated
- 14 Jun 2007
- Results posted
- No
Publications
Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
PubMed 17296917
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.
- ClinicalTrials.gov ID
- NCT00046722
- Acronym / sponsor ID
- C00-SF-101
- Conditions
- Peripheral Nervous System Diseases, HIV Infections
- Keywords
- treatment experienced, complementary therapies, Neuropathy, Peripheral Neuropathy, HIV-Related Peripheral Neuropathy, HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Center for Medicinal Cannabis ResearchUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Apr 2005
- First posted
- 3 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 evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.
Detailed description
The study will include subjects with peripheral neuropathy caused either by HIV-disease or antiretroviral medication for the treatment of HIV. A neurologist will conduct a neurological and pain evaluation to determine eligibility for the study. Subjects who meet all eligibility criteria will be admitted to the General Clinical Research Center at San Francisco General Hospital for seven days. Subjects will be randomized (like a toss of a coin) to smoke marijuana or a placebo (cigarettes with no THC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV positive.
- Be 18 years or older.
- Diagnosis of HIV-related painful neuropathy.
- Stable antiretroviral therapy or no antiretroviral therapy for at least 8 weeks.
- Prior use of marijuana, at least 6 occasions in their lifetime prior to enrollment.
Key exclusion criteria (8 listed)
- Current use of smoked tobacco products.
- Current methadone treatment.
- Use of smoked marijuana within 30 days of enrollment.
- Diagnosis of diabetes mellitus.
- Currently receiving treatment with corticosteroids.
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 HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
1 secondary outcome
Change in level of experimentally-induced pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2007.
- Results publication: PubMed 17296917Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
- Community ConsortiumLink provided by the sponsor.
- 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 Peripheral Nervous System Diseases and HIV Infections, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 14 Jun 2007. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 HIV-related neuropathic 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?
On the ClinicalTrials.gov record for NCT00046722, which also lists 1 linked publication.
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 14 Jun 2007.