Marijuana for HIV-Related Peripheral Neuropathy

Center for Medicinal Cannabis Research

Status and phase: Completed; Phase 2; Phase 1

Conditions: Peripheral Nervous System Diseases; HIV Infections

Treatments: Drug: Smoked Marijuana

Study type: Interventional

Funder types: Other

Identifiers

NCT00046722

C00-SF-101

CC# 056

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind