Medicinal Cannabis for Painful HIV Neuropathy
Neuropathic Pain
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring neuropathy, cannabis, marijuana, HIV, DSPN
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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study protocol Active AIDS-defining opportunistic disease (a history of AIDS-defining opportunistic disease which is no longer active or progressing will not be grounds for exclusion) Diabetes mellitus, renal failure with uremia, alcohol abuse, previous spinal surgery, or other documented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
Sites / Locations
- UC San Diego, Hillcrest Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Active cannabis (1-8% THC by weight)
Placebo cannabis