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Marijuana for HIV-Related Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00046722
First Posted: October 3, 2002
Last Update Posted: June 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Center for Medicinal Cannabis Research
October 1, 2002
October 3, 2002
June 14, 2007
January 2003
Not Provided
Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
Not Provided
Complete list of historical versions of study NCT00046722 on ClinicalTrials.gov Archive Site
Change in level of experimentally-induced pain.
Not Provided
Not Provided
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Marijuana for HIV-Related Peripheral Neuropathy
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.
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).
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Peripheral Nervous System Diseases
  • HIV Infections
Drug: Smoked Marijuana
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2005
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00046722
C00-SF-101
CC# 056
Not Provided
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Center for Medicinal Cannabis Research
Not Provided
Principal Investigator: Donald I Abrams, M.D. UCSF Community Consortium
Center for Medicinal Cannabis Research
June 2007

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