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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
  Purpose
To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.

Condition Intervention Phase
Peripheral Nervous System Diseases HIV Infections Drug: Smoked Marijuana Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.

Resource links provided by NLM:


Further study details as provided by Center for Medicinal Cannabis Research:

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.

Estimated Enrollment: 50
Study Start Date: January 2003
Estimated Study Completion Date: April 2005
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00046722


Locations
United States, California
University of California, San Francisco Community Consortium
San Francisco, California, United States, 94110
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Investigators
Principal Investigator: Donald I Abrams, M.D. UCSF Community Consortium
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00046722     History of Changes
Other Study ID Numbers: C00-SF-101
CC# 056
First Submitted: October 1, 2002
First Posted: October 3, 2002
Last Update Posted: June 14, 2007
Last Verified: June 2007

Keywords provided by Center for Medicinal Cannabis Research:
treatment experienced
complementary therapies
Neuropathy
Peripheral Neuropathy
HIV-Related Peripheral Neuropathy
HIV

Additional relevant MeSH terms:
HIV Infections
Peripheral Nervous System Diseases
Nervous System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neuromuscular Diseases