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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
UC San Diego, Hillcrest Medical Center
San Diego, California, United States
Descriptor Differential Scale (DDS)
Time frame: Baseline, Post-treatment
Changes in the use of opioid and non-opioid analgesics
Time frame: Post-Treatment
Changes in measures of everyday functioning and subject-perceived quality of life
Time frame: Baseline, Post-Treatment
Adverse effects
Time frame: Post-Treatment
Adverse cognitive effects as assessed by neuropsychological testing.
Time frame: Baseline, Post-Treatment
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