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Sponsored by: |
Center for Medicinal Cannabis Research |
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Information provided by: | Center for Medicinal Cannabis Research |
ClinicalTrials.gov Identifier: | NCT00255580 |
The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and effective for treating pain in individuals with HIV-associated distal, sensory-predominant polyneuropathy (DSPN).
Condition | Intervention | Phase |
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Neuropathic Pain |
Drug: Smoked cannabis |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy |
Enrollment: | 28 |
Study Start Date: | September 2001 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active cannabis (1-8% THC by weight)
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Drug: Smoked cannabis |
2: Placebo Comparator
Placebo cannabis
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Drug: Smoked cannabis |
Peripheral neuropathy occurs in over 30% of patients with HIV infection, making it among the most common neurological complications of HIV infection. Nucleoside analogues such as ddI and d4T, key components of modern, potent, combination antiretroviral therapies (ART), are also neurotoxic and contribute to the frequent occurence of painful neuropathy. By using treatment with available non-narcotic analgesic and adjunctive pain medications, approximately half of patients with painful HIV neuropathy obtain sufficient pain control.
On the first day each study week (active or placebo), participants will follow a specific titration procedure to achieve the optimal dose. This optimal dose will then be continued for the duration of the treatment week.
Participants will undergo a 2-week washout period, after which they crossover to the other arm (active or placebo) and will again repeat the dose titration and dose maintenance procedures.
Comparison: Active cannabis doses ranging from 2-8% THC will be compared to placebo for the reduction of neuropathic pain.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UC San Diego, Hillcrest Medical Center | |
San Diego, California, United States, 92103 |
Principal Investigator: | Ronald Ellis, M.D., Ph.D. | University of California, San Diego |
Responsible Party: | University of California, San Diego ( Ronald J. Ellis, M.D., Ph.D. ) |
Study ID Numbers: | C00-SD-104 |
Study First Received: | November 17, 2005 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00255580 History of Changes |
Health Authority: | United States: Food and Drug Administration |
neuropathy cannabis marijuana HIV DSPN |
HIV Infections Acquired Immunodeficiency Syndrome Pain Marijuana Abuse |