Marijuana for HIV-Related Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-04-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Peripheral Nervous System Diseases HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Smoked Marijuana

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Donald I Abrams, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCSF Community Consortium

Locations

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University of California, San Francisco Community Consortium

San Francisco, California, United States

Site Status

Countries

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United States

References

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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. doi: 10.1212/01.wnl.0000253187.66183.9c.

Reference Type RESULT

PMID: 17296917 (View on PubMed)

Other Identifiers

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CC# 056

Identifier Type: -

Identifier Source: secondary_id

C00-SF-101