Marijuana for HIV-Related Peripheral Neuropathy

HIV Infections Clinical Trial

Official title:

Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046722
• Other study ID #: C00-SF-101
• Secondary ID: CC# 056
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 1, 2002
• Last updated: June 12, 2007
• Start date: January 2003
• Est. completion date: April 2005

Study information

• Verified date: June 2007
• Source: Center for Medicinal Cannabis Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Drug:
• Smoked Marijuana

Locations

Country	Name	City	State
United States	University of California, San Francisco Community Consortium	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Center for Medicinal Cannabis Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
Secondary	Change in level of experimentally-induced pain.

External Links

•   Center for Medicinal Cannabis Research