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Completed

NCT Number: NCT00046722

Marijuana for HIV-Related Peripheral Neuropathy

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

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Key information

Conditions

Peripheral Nervous System Diseases Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Nervous System Diseases Neuromuscular Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California, San Francisco Community Consortium

San Francisco, California, 94110, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smoked Marijuana

Drug

Primary outcomes

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

Secondary outcomes

  1. Change in level of experimentally-induced pain.

Sponsors and collaborators

Lead sponsor

Center for Medicinal Cannabis Research

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Oct 3, 2002
Registry last updated
Jun 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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