Marijuana for HIV-Related Peripheral Neuropathy

June 12, 2007 updated by: Center for Medicinal Cannabis Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • University of California, San Francisco Community Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.

Secondary Outcome Measures

Outcome Measure
Change in level of experimentally-induced pain.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Medicinal Cannabis Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

October 1, 2002

First Submitted That Met QC Criteria

October 2, 2002

First Posted (Estimate)

October 3, 2002

Study Record Updates

Last Update Posted (Estimate)

June 14, 2007

Last Update Submitted That Met QC Criteria

June 12, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C00-SF-101
  • CC# 056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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