Status:
COMPLETED
Medicinal Cannabis for Painful HIV Neuropathy
Lead Sponsor:
Center for Medicinal Cannabis Research
Conditions:
Neuropathic Pain
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
PHASE2
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 comp...
Eligibility Criteria
Inclusion
- Documented HIV infection
- Meets clinical and electrodiagnostic criteria for HIV-associated DSPN at entry
- Daily pain for at least three consecutive months with an average daily pain magnitude score of at least 5 on the Descriptor Differential Scale
- Inadequate pain relief with prior treatment for painful HIV neuropathy using drugs from at least two different classes of pain-modifying agents (NSAIDS, low-potency opioids, high-potency opioids, sodium channel blockers, other adjunctive pain treatments)
- Age 21-65 years
- Stable use of opioid and non-opioid analgesic medications during the two weeks prior to study entry
Exclusion
- Positive urine toxicology screen for cannabinoids during the "wash-in" week prior to initiating study treatment
- Recent (i.e. during the month prior to study entry) history of marijuana use more than twice a week
- Previous psychosis with or intolerance to cannabinoids
- A lifetime history (ever) of dependence on cannabis
- Meeting criteria for alcohol or drug dependence within the last 12 months
- Active, major psychiatric disorder likely, in the investigator's opinion, to interfere with adherence to the study protocol
- Active AIDS-defining opportunistic disease (a history of AIDS-defining opportunistic disease which is no longer active or progressing will not be grounds for exclusion)
- Diabetes mellitus, renal failure with uremia, alcohol abuse, previous spinal surgery, or other documented causes of neuropathy or neuropathic pain
- Pulmonary disease of sufficient severity to require the use of supplemental oxygen
- Asthma
- Life expectancy less than 6 weeks or an active, acute illness likely to interfere with completion of the study protocol
- Pregnancy
- Failure to use adequate birth control in an individual with reproductive potential
- Minority status (less than 21 years), or persons over age 65 years
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00255580
Start Date
September 1 2001
End Date
November 1 2006
Last Update
February 28 2008
Active Locations (1)
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1
UC San Diego, Hillcrest Medical Center
San Diego, California, United States, 92103