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Chronic Cannabis Use in the Compassionate Investigational New Drug Program

Authors:

Ethan Russo, Mary Lynn Mathre, Al Byrne, Robert Velin, Paul J. Bach, Juan Sanchez-Ramos, Kristin A. Kirlin


Published in Journal of Cannabis Therapeutics

2002

 

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.

 

DOI:10.1300/J175v02n01_02

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Citation:

Russo E, Mathre ML, Byrne A, et al. Chronic Cannabis Use in the Compassionate Investigational New Drug Program. J Cannabis Ther. 2002;2(1):3-57. doi:10.1300/J175v02n01_02