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Clinical Trials

Clinical trials involve studies of a potential medication with real patients. The gold standard for a drug to be approved as medicine is to have randomized double-blind placebo-controlled clinical trials to validate the efficacy of such drug. Double blind means that the patients and the medication dispensers do not know which medication (test drug or placebo) is being given at any time during the study. Placebo-controlled means that the effects of drug to be studied will be compared to the effects of a placebo given to a patient population. The U.S. federal government, legislators, law enforcement officers and many healthcare professionals often use the “lack of clinical trials” with cannabis as a legitimate reason for continuing the marijuana prohibition. The Catch 22 here is that the federal government has made it virtually impossible for researchers to study the therapeutic efficacy of cannabis.

Patients Out of Time strongly believes that there has been more than enough research to validate that cannabis is a safe and effective medication. If not for the reefer madnessin the 1930s that led to the Marihuana Tax Act of 1937, which marked the beginning of the cannabis prohibition and the removal of cannabis from the pharmacopoedia, cannabis would have been grandfathered into modern medicine as was aspirin.

Patients Out of Time strongly supports clinical trials with cannabis. The Institute of Medicine’s 1999 report on Marijuana as Medicine: Assessing the Science Base (pdf) noted the safety of cannabis and recommended that physicians be allowed to conduct n of 1 studies (n refers to the sample size, thus it would be a study to evaluate the effects of a drug on one patient). In other words, a physician should be allowed to prescribe cannabis to a patient who is not responding to current treatment to see if cannabis would be effective. All practicing physicians should be able to do such studies that can eventually result in large numbers. At the same time, large well designed clinical trials are strongly recommended for various patient populations.

The primary purpose of our biennial conference series is to present evidence-based research on the safety and efficacy of cannabis. Listed below you will find links to papers and conference presentations on clinical trials with cannabis or cannabinoids.

Faculty Presentations of Clinical Trials

img 1 abrams04AIDS and Pain: An HHS Study, by Donald Abrams, MD – Donald Abrams, Professor of Clinical Medicine, University of California, San Francisco, describes methodology of double-blind, placebo-controlled trial to determine if smoked marijuana is an effective analgesic for HIV patients with neuropathic pain. Dr. Abrams also explains how State of California sponsorship of Medical Marijuana resulted in the University of CA Center for Medicinal Cannabis Research.

img 2 guy04Oromuscosal Cannabis-based Medicine, Geoffrey Guy, MD  – “From Plant to Prescription Medicine” – Introduced by Don Wirtshafter, Geoffrey Guy, Founder and Executive Chairman, GW Pharmaceuticals, UK, explains why extracts of Phyto-Cannabinoids THC & CBD need to represent the natural balance of the Cannabis plant. Describing Cannabinoid action as a “Super-Modulator”, Dr. Guy discusses clinical trials involving Multiple Sclerosis (MS), spinal cord injury and neuropathic pain.

img 3ware2002 Medical Cannabis in Canada – Chronic Pain Trial by Mark Ware, MD – Beginning with a history of medical marijuana in Canada, Dr. Mark Ware, associate medical director at McGill University Health Centre in Montreal, discusses methods of using Cannabis – concluding that pipes and vaporizers are superior to “joints”. Dr. Ware then outlines his pilot study of chronic neuropathic pain, calling for more research on benefits and risks of medical marijuana to satisfy medical profession’s need for objective science – meeting the “challenges of applying modern scientific methodology to a sacred herb”.

Suggested Reading

Abrams, D. I., Hilton, J. F., Leiser, R. J., Shade, S. B., Elbeik, T. A., Aweeka, F. T., et al. (2003). Short-term effects of cannabinoids in patients with HIV-1 infection. A randomized, placbo-controlled clinical trial. Ann Intern Med, 139, 258-266.

Abrams, D. I., Jay, C. A., Shade, S. B., Vizoso, H., Reda, H., Press, S., et al. (2007). Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology, 68(7), 515-521.

Ellis, R. J., Toperoff, W., Vaida, F., van den Brande, G., Gonzales, J., Gouaux, B., et al. (2008). Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology, 34(3), 672-680.

Abrams, D. I., Vizoso, H. P., Shade, S. B., Jay, C., Kelly, M. E., & Benowitz, N. L. (2007). Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther.

Blake, D. R., Robson, P., Ho, M., Jubb, R. W., & McCabe, C. S. (2006). Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Rheumatology (Oxford), 45(1), 50-52.

Brady, C. M., DasGupta, R., Dalton, C., Wiseman, O. J., Berkley, K. J., & Fowler, C. J. (2004). An open-label pilot study of cannabis based extracts for bladder dysfunction in advanced multiple sclerosis. Multiple Sclerosis, 10, 425-433.

Collin, C., Davies, P., Mutiboko, I. K., & Ratcliffe, S. (2007). Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol, 14(3), 290-296.

Haney, M., Gunderson, E. W., Rabkin, J., Hart, C. L., Vosburg, S. K., Comer, S. D., et al. (2007). Dronabinol and marijuana in HIV-positive marijuana smokers. Caloric intake, mood, and sleep. J Acquir Immune Defic Syndr, 45(5), 545-554.

Lynch, M. E., Young, J., & Clark, A. J. (2006). A case series of patients using medicinal marihuana for management of chronic pain under the Canadian Marihuana Medical Access Regulations. J Pain Symptom Manage, 32(5), 497-501.

Musty, R. E., & Rossi, R. (2001). Effects of smoked cannabis and oral delta-9-tetrahydrocannabinol on nausea and emesis after cancer chemotherapy: A review of state clinical trials. Journal of Cannabis Therapeutics, 1(1), 29-42.

Notcutt, W., Price, M., Miller, R., Newport, S., Phillips, C., Simmonds, S., et al. (2004). Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 “N of 1″ studies. Anaesthesia, 59, 440-452.

Notcutt, W. G., Sharief, M., Mutiboko, I., Hawkes, C., Bolt, J., & Sarantis, N. (2006). Cannabis based medicine (Sativex) for chronic pain due to multiple sclerosis or other neurological dysfunction: a randomised controlled trial. European Journal of Pain, (in press).

Nurmikko, T. J., Serpell, M. G., Hoggart, B., Toomey, P. J., & Morlion, B. J. (2005). A multi-center, double-blind, randomized, placebo-controlled trial of oro-mucosal cannabis-based medicine in the treatment of neuropathic pain characterized by allodynia. Neurology, 64(6, Suppl. 1), A374.

Rog, D. J., Nurmiko, T., Friede, T., & Young, C. (2005). Randomized controlled trial of cannabis based medicine in central neuropathic pain due to multiple sclerosis. Neurology, 65(6), 812-819.

Russo, E. B. (2008). Cannabinoids in the management of difficult to treat pain. Therapeutics and Clinical Risk Management, 4(1), 245-259.

Russo, E. B., Guy, G. W., & Robson, P. J. (2007). Cannabis, Pain, and Sleep: Lessons from Therapeutic Clinical Trials of Sativex((R)), a Cannabis-Based Medicine. Chem Biodivers, 4(8), 1729-1743.

Russo, E. B., Mathre, M. L., Byrne, A., Velin, R., Bach, P. J., Sanchez-Ramos, J., et al. (2002). Chronic cannabis use in the Compassionate Investigational New Drug Program: An examination of benefits and adverse effects of legal clinical cannabis. Journal of Cannabis Therapeutics, 2(1), 3-57.

Schley, M., Legler, A., Skopp, G., Schmelz, M., Konrad, C., & Rukwied, R. (2006). Delta-9-THC based monotherapy in fibromyalgia patients on experimentally induced pain, axon reflex flare, and pain relief. Curr Med Res Opin, 22(7), 1269-1276.

Wade, D. T., Makela, P., Robson, P., House, H., & Bateman, C. (2004). Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Mult Scler, 10(4), 434-441.

Wade, D. T., Makela, P. M., House, H., Bateman, C., & Robson, P. J. (2006). Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis. Multiple Sclerosis, 12, 639-645.

Wade, D. T., Robson, P., House, H., Makela, P., & Aram, J. (2003). A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. Clinical Rehabilitation, 17, 18-26.

Wallace, M., Schulteis, G., Atkinson, J. H., Wolfson, T., Lazzaretto, D., Bentley, H., et al. (2007). Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology, 107(5), 785-796.

Walther, S., Mahlberg, R., Eichmann, U., & Kunz, D. (2006). Delta-9-tetrahydrocannabinol for nighttime agitation in severe dementia. Psychopharmacology (Berl), 185(4), 524-528.

Ware, M. A., Ducruet, T., & Robinson, A. R. (2006). Evaluation of herbal cannabis characteristics by medical users: a randomized trial. Harm Reduct J, 3, 32.

Wilsey, B., Marcotte, T., Tsodikov, A., Millman, J., Bentley, H., Gouaux, B., et al. (2008). A Randomized, Placebo-Controlled, Crossover Trial of Cannabis Cigarettes in Neuropathic Pain. J Pain.

Zajicek, J., Fox, P., Sanders, H., Wright, D., Vickery, J., Nunn, A., et al. (2003). Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet, 362(9395), 1517-1526.

Zajicek, J. P., Sanders, H. P., Wright, D. E., Vickery, P. J., Ingram, W. M., Reilly, S. M., et al. (2005). Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up. J Neurol Neurosurg Psychiatry, 76 (12), 1664-1669.

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