Marijuana for HIV-Related Peripheral Neuropathy

• Sponsor: Center for Medicinal Cannabis Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00046722
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 27
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nervous System Diseases; HIV Infections	Drug: Smoked Marijuana	Phase 1/Phase 2

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

• Study Type: Interventional
• 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.
• Study Start Date: Jan 1, 2003
• Study Completion Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

1. Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale. []

Secondary Outcome Measures

1. Change in level of experimentally-induced pain. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Center for Medicinal Cannabis Research

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00046722
• Other Study ID Numbers: C00-SF-101; CC# 056
• First Posted: Oct 3, 2002
• Last Update Posted: Jun 14, 2007
• Last Verified: Jun 1, 2007

• Keywords provided by , ,: treatment experienced; complementary therapies; Neuropathy; Peripheral Neuropathy; HIV-Related Peripheral Neuropathy; HIV
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Nervous System Diseases

Study Results

No Results Posted as of Jun 14, 2007