Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2001-09-30
2006-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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1
Active cannabis (1-8% THC by weight)
Smoked cannabis
2
Placebo cannabis
Smoked cannabis
Interventions
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Smoked cannabis
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
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Center for Medicinal Cannabis Research
OTHER
Responsible Party
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University of California, San Diego
Principal Investigators
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Ronald Ellis, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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UC San Diego, Hillcrest Medical Center
San Diego, California, United States
Countries
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Related Links
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Center for Medicinal Cannabis Research
HIV Neurobehavioral Research Center
Other Identifiers
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C00-SD-104
Identifier Type: -
Identifier Source: org_study_id