Placebo-controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy

INVESTIGATOR: Ronald Ellis, M.D., Ph.D.

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: Placebo-controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy

PROJECT TYPE: Clinical Study

STATUS: COMPLETE

RESULTS:

Of 127 volunteers screened, 34 eligible subjects enarolled and 28 completed both cannabis and placebo treatments. Among completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size = 0.60; p = 0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 [95% CI 0.28, 0.65] and 0.18 [0.03, 0.32]. Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities.

Smoked cannabis was generally well-tolerated and effective when added to concomitant analgesic therapy in patients with medically refractory pain due to HIV DSPN.

The full results of this study were published in the journal Neuropsychopharmacology.

ABSTRACT:

Neuropathic pain continues to be a major clinical problem in HIV infection. The predominant cause is an axonal polyneuropathy, termed HIV-associated distal, sensory-predominant polyneuropathy (DSPN) that is variably associated with HIV itself or with the use of certain nucleoside analogue HIV reverse transcriptase inhibitors used in antiretroviral treatment regimens. Available treatments, including opioids and adjunctive pain-modulating agents, often are ineffective for pain control, resulting in disability and diminished quality of life for individuals with HIV infection. The proposed study will be a double-blind, placebo-controlled trial of medicinal cannabis for the short-term adjunctive treatment of neuropathic pain in HIV-associated DSPN. Case ascertainment will be by history, physical examination, nerve conduction studies and quantitative sensory testing. Thirty subjects will be enrolled in a double-blind, cross-over trial design. Because a safe and effective dosing range for cannabis for neuropathic pain has not been previously established, and because we anticipate that the frequency and magnitude of both beneficial antinociceptive and adverse drug effects with cannabis will differ substantially across individuals, a structured dose escalation-titration protocol will be used to find an individualized, effective, safe and well-tolerated and dose for each subject. The total study duration will be 3 years. The principal outcome measures will be changes in self-reported pain, disability in activities of daily living and indices of quality of life.

PUBLICATIONS:

Type:

Title:

Journal Article Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. (2009). Smoked Medicinal Cannabis for Neuropathic Pain in HIV: A Randomized, Crossover Clinical Trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.

Weed Is Everywhere, So Why Is It Still A Medical Mystery?

Seeker, June 23, 2019


Regulators hungry for evidence as FDA weighs allowing CBD in food, dietary supplements

Angelica LaVito, CNBC, May 31, 2019

Food and Drug Administration regulators grilled manufacturers and advocates Friday for evidence that CBD actually does anything they claim it does.

Companies are adding CBD, short for cannabidiol, to just about everything, including makeup, tea, pet treats and soft drinks — even though there's little data to support the many claims of its benefits. FDA regulators trying to learn more about the cannabis compound held the agency's first hearing on it Friday.

More than 100 people testified at the hearing. Speakers pushed the FDA to set up a regulatory framework to legally add CBD to food products and dietary supplements. They praised CBD and the purported benefits — and FDA panelists repeatedly asked for data. Scientists warned of the little research and many potential risks CBD brings.

Read the story here


Three years into legal cannabis and California still doesn’t have a reliable test for driving while high

Brooke Staggs, Orange County Register, May 31, 2019

Nearly three years after California voters approved a cannabis legalization bill that promised, among other things, to clarify the issue of driving while high, researchers and law enforcement have few concrete answers about a potentially deadly problem.

It’s unclear, for example, if marijuana-related arrests or car crashes have increased statewide. It’s up to each county to track that data, and many still don’t distinguish between cannabis and other drugs in their arrest and accident reports.

There also aren’t yet any reliable methods for testing whether drivers were actually impaired by marijuana when they’re behind the wheel. Research in this area is hampered by federal law and left scrambling to catch up with the wave of marijuana legalization that continues to sweep the country.

Read the rest of the article here


More News

Click here to access the CMCR news archives.

Igor Grant, MD

Marijuana as Medicine: Can We See Past the Smoke?
North American Cannabis Summit presentation January 2019 (PDF)


Igor Grant, MD

Introduction/Overview
CMCR Symposium, June 2018


Daniele Piomelli, MD, PhD, PharmD

The health impact of cannabis
CMCR Symposium, June 2018


Ziva Cooper, PhD

Therapeutic potential of cannabis for pain alone and as an adjunct to opioids
CMCR Symposium, June 2018


Iain McGregor, PhD

Medicinal cannabis research down under: Introducing the Lambert Initiative for Cannabinoid Therapeutics
CMCR Symposium, June 2018


Copyright © 2019 CENTER FOR MEDICINAL CANNABIS RESEARCH. | University of California, San Diego
cmcr@ucsd.edu | HNRP |