Marijuana for HIV-Related Peripheral Neuropathy - Full Text View

Sponsor:	Center for Medicinal Cannabis Research
Information provided by:	Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:	NCT00046722

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 I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Marijuana Neurologic Diseases Peripheral Nerve Disorders

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Community Consortium This link exits the ClinicalTrials.gov site

Center for Medicinal Cannabis Research This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00046722 History of Changes
Other Study ID Numbers:	C00-SF-101, CC# 056
Study First Received:	October 1, 2002
Last Updated:	June 12, 2007
Health Authority:	United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Peripheral 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
Slow Virus Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on February 13, 2012