NCT00255580

Medicinal Cannabis for Painful HIV Neuropathy

Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Center for Medicinal Cannabis Research · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Smoked cannabis

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-11-21
• Last updated: 2008-02-28

Locations

1 site across 1 country: United States