Medicinal Cannabis for Painful HIV Neuropathy
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy|
- Descriptor Differential Scale (DDS) [ Time Frame: Baseline, Post-treatment ] [ Designated as safety issue: No ]
- Changes in the use of opioid and non-opioid analgesics [ Time Frame: Post-Treatment ] [ Designated as safety issue: No ]
- Changes in measures of everyday functioning and subject-perceived quality of life [ Time Frame: Baseline, Post-Treatment ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: Post-Treatment ] [ Designated as safety issue: Yes ]
- Adverse cognitive effects as assessed by neuropsychological testing. [ Time Frame: Baseline, Post-Treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2001|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Active cannabis (1-8% THC by weight)
|Drug: Smoked cannabis|
Placebo Comparator: 2
|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.
|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|