Back to resultsMarijuana for HIV-Related Peripheral Neuropathy
Primary Purpose
Peripheral Nervous System Diseases, HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smoked Marijuana
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nervous System Diseases focused on measuring treatment experienced, complementary therapies, Neuropathy, Peripheral Neuropathy, HIV-Related Peripheral Neuropathy, HIV
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: (Not allowed) 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.
Sites / Locations
- University of California, San Francisco Community Consortium
Outcomes
Primary Outcome Measures
Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
Secondary Outcome Measures
Change in level of experimentally-induced pain.
Full Information
NCT ID
NCT00046722
First Posted
October 1, 2002
Last Updated
June 12, 2007
Sponsor
Center for Medicinal Cannabis Research
1. Study Identification
Unique Protocol Identification Number
NCT00046722
Brief Title
Marijuana for HIV-Related Peripheral Neuropathy
Official Title
Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Center for Medicinal Cannabis Research
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nervous System Diseases, HIV Infections
Keywords
treatment experienced, complementary therapies, Neuropathy, Peripheral Neuropathy, HIV-Related Peripheral Neuropathy, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Smoked Marijuana
Primary Outcome Measure Information:
Title
Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
Secondary Outcome Measure Information:
Title
Change in level of experimentally-induced pain.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA: (Not allowed)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald I Abrams, M.D.
Organizational Affiliation
UCSF Community Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco Community Consortium
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17296917
Citation
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.
Results Reference
result
Links:
URL
http://www.communityconsortium.org
Description
Community Consortium
URL
http://cmcr.ucsd.edu
Description
Center for Medicinal Cannabis Research
Learn more about this trial
Marijuana for HIV-Related Peripheral Neuropathy
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