Medicinal Cannabis for Painful HIV Neuropathy

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Medicinal Cannabis Research

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• Active AIDS-defining opportunistic disease (a history of AIDS-defining opportunistic disease which is no longer active or progressing will not be grounds for exclusion)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