Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255580
Status:
COMPLETED
Last Update Posted:
2008-02-28
First Post:
2005-11-17
Brief Title:
Medicinal Cannabis for Painful HIV Neuropathy
Sponsor:
Center for Medicinal Cannabis Research
Organization:
Center for Medicinal Cannabis Research
Study Overview
Official Title:
Placebo-Controlled Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None