Cannabis for Treatment of HIV-Related Peripheral Neuropathy

INVESTIGATOR: Donald Abrams, M.D.

STUDY LOCATION: University of California, San Francisco

PROJECT TITLE: Cannabis for Treatment of HIV-Related Peripheral Neuropathy

PROJECT TYPE: Clinical Study

STATUS: COMPLETE

RESULTS:

The full results of this study appear in the February 13, 2007 issue of the journal Neurology. A full version of the article can be found here*. Below is a brief summary of these results.

Dr. Abrams and the Community Consortium conducted a study to evaluate the safety and effectiveness of smoked marijuana to treat pain caused by HIV-related peripheral neuropathy (injury to the nerves that supply feelings to your arms and feet). The study evaluated whether marijuana had an effect on pain relief. Marijuana was compared to a placebo; a cigarette that smells and tastes like marijuana but has no active ingredients (THC).

The study evaluated both ongoing neuropathic pain (clinical pain) and temporary pain induced by applying heat and capsaicin (ingredient that makes red peppers hot) cream to a small area of the skin (experimental pain).

Fifty-five patients were randomized and 50 completed the entire trial. Smoked marijuana reduced daily pain by 34% compared to 17% with placebo. The study concluded that 52% of patients who smoked marijuana had a greater than 30% reduction in pain compared to 24% in the placebo group. In this study, smoked marijuana was well tolerated and effectively relieved chronic neuropathic pain from HIV-related peripheral neuropathy. The findings are comparable to clinically proven oral drugs for chronic neuropathic pain.

ABSTRACT:

The primary objective of this study was to evaluate the efficacy of smoked marijuana when used as an analgesic in persons with neuropathic pain due to HIV-related peripheral neuropathy. To do this, we first conducted a non-randomized pilot study that assessed the anticipated analgesic effects of the drug and provide estimates of response rate, variance and time to treatment effect. Based on evidence of a treatment effect in the pilot study, we conducted a randomized, double-blind, placebo-controlled clinical efficacy study. In addition to assessing the analgesic effects of smoked marijuana on neuropathic pain, individual differences in subjective relief of pain were be anchored by an assessment of the analgesic effects of smoked marijuana on experimentally-induced pain using a heat/capsaicin experimental pain model and cutaneous secondary hyperalgesia. Plasma THC levels and changes in mood were measured in both studies as covariates. Sixteen subjects were enrolled in the pilot study.

Both studies were conducted in the General Clinical Research Center at San Francisco General Hospital. The inpatient setting permitted us to measure plasma THC levels as a means to assess the total dose delivered, and to rigorously assess the primary outcome measures - changes in intensity of pain as measured by a visual analog scale - at multiple time points during the intervention phases. Both studies were comprised of two phases: a 2-day lead-in period in which baseline measurements are obtained, followed immediately by an intervention phase that will last either 7 days (the pilot study) or 5 days (the randomized, controlled trial). In the pilot study, all subjects received smoked marijuana cigarettes. In the randomized study, subjects received either smoked marijuana or placebo marijuana THC cigarettes. The heat/capsaicin experimental pain model was used in both studies to assess drug response to quantifiable and reproducible experimentally-induced pain. Subjects in both studies continued any concurrent analgesic medications (e.g., gabapentin, amytriptyline, narcotics, NSAIDs) they were taking by prescription. They were asked to maintain the same dose and frequency while in the study, which was recorded daily.

PUBLICATIONS:

Type:

Title:

Journal Article Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: A randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21.
Meeting Abstract Abrams, D., Jay, C., Vizoso, H., Shade, S., Reda, H., Press, S., Kelley, M.E., Rowbotham, M., Petersen, K. Smoked Cannabis Therapy for HIV-Related Painful Peripheral Neuropathy: Results of a Randomized, Placebo-Controlled Clinical Trial. 2nd Annual Meeting of the International Association for Cannabis as Medicine. 2005.
Meeting Abstract Ilan, A., Gevins, A., Role, K., Vizoso, H., Abrams, D. The Cognitive Neuropysiological Effects of Medicinal Marijuana in HIV+ Patients with Peripheral Neuropathy. 2nd Annual Meeting of the International Association for Cannabis as Medicine. 2005.
Meeting Abstract Jay, C., Shade, S., Vizoso, H., Reda, H., Petersen, K., Rowbotham, M., Abrams, D. The Effect of Smoked Marijuana on Chronic Neuropathic and Experimentally-Induced Pain in HIV Neuropathy: Results of an Open-Label Pilot Study. Proceedings 11th Conference on Retroviruses and Opportunistic Infections, abstract 496, p.243, 2004.
Meeting Abstract Abrams, D.I., Jay, C., Petersen, K., Shade, S., Vizoso, H., Reda, H., Benowitz, N., Rowbotham, M. The Effects of Smoked Cannabis in Painful Peripheral Neuropathy and Cancer Pain Refractory to Opioids. Proceedings of the International Association of Cannabis as Medicine, Cologne, 2003, p.28.

*Published with permission from Lippincott Williams & Wilkins, a division of Wolters Kluwer Health. http://www.lww.com.

Funding Opportunity Announcement

The Center for Medicinal Cannabis Research (CMCR) is seeking to fund primary and pilot cannabis-related studies that further enhance the understanding of the efficacy and adverse effects of cannabis and cannabinoids as pharmacological agents for the treatment of medical and psychiatric disorders, and their potential public health impacts. More information about this funding opportunity, including application instructions and important dates can be found in the request for applications (RFA).


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