Medicinal Cannabis for Painful HIV Neuropathy

Completed · Phase 1/Phase 2

Conditions studied: Neuropathic Pain

In brief

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).

Key facts

Study ID

NCT00255580

Run by

Center for Medicinal Cannabis Research

People needed

28

Starts

2001-09-01

Expected to finish

2006-11-01

Last updated by the study team

2008-02-28

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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• Active AIDS-defining opportunistic disease (a history of AIDS-defining opportunistic disease which is no longer active or progressing will not be grounds for exclusion)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

Where it is running

• UC San Diego, Hillcrest Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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