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Original Articles

Chronic Cannabis Use in the Compassionate Investigational New Drug Program

An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis

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Pages 3-57 | Received 21 Jun 2001, Accepted 10 Aug 2001, Published online: 20 Oct 2008
 

Abstract

The Missoula Chronic Clinical Cannabis Use Study was proposed to investigate the therapeutic bepnefits and adverse effects of prolonged use of “medical marijuana” in a cohort of seriously ill patients. Use of cannabis was approved through the Compassionate Inves-tigational New Drug (IND) program of the Food and Drug Administration (FDA). Cannabis is obtained from the National Institute on Drug Abuse (NIDA), and is utilized under the supervision of a study physician. The aim of this study is to examine the overall health status of 4 of the 7 surviving patients in the program. This project provides the first opportunity to scrutinize the long-term effects of cannabis on patients who have used a known dosage of a standardized, heat-sterilized quality-controlled supply of low-grade marijuana for 11 to 27 years.

Results demonstrate clinical effectiveness in these patients in treating glaucoma, chronic musculoskeletal pain, spasm and nausea, and spasticity of multiple sclerosis. All 4 patients are stable with respect to their chronic conditions, and are taking many fewer standard pharmaceuticals than previously.

Mild changes in pulmonary function were observed in 2 patients, while no functionally significant attributable sequelae were noted in any other physiological system examined in the study, which included: MRI scans of the brain, pulmonary function tests, chest X-ray, neuropsy-chological tests, hormone and immunological assays, electroencepha-lography, P300 testing, history, and neurological clinical examination.

These results would support the provision of clinical cannabis to a greater number of patients in need. We believe that cannabis can be a safe and effective medicine with various suggested improvements in the existing Compassionate IND program.

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