Medicinal Cannabis for Painful HIV Neuropathy
|ClinicalTrials.gov Identifier: NCT00255580|
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : February 28, 2008
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: Smoked cannabis||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy|
|Study Start Date :||September 2001|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
Active cannabis (1-8% THC by weight)
|Drug: Smoked cannabis|
Placebo Comparator: 2
|Drug: Smoked cannabis|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255580
|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|