Efficacy of Inhaled Cannabis in Diabetic Peripheral Neuropathy

INVESTIGATOR: Mark Wallace, M.D.

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: Efficacy of Inhaled Cannabis in Diabetic Peripheral Neuropathy

PROJECT TYPE: Clinical Study

STATUS: COMPLETE

RESULTS:

A randomized, double-blinded, placebo controlled crossover study was conducted in 16 patients with painful diabetic peripheral neuropathy to assess the short-term efficacy and tolerability of inhaled cannabis. In a crossover design, each participant was exposed to 4 single dosing sessions of placebo or to low (1% tetrahydrocannabinol [THC]), medium (4% THC), or high (7% THC) doses of cannabis. Baseline spontaneous pain, evoked pain, and cognitive testing were performed. Subjects were then administered aerosolized cannabis or placebo and the pain intensity and subjective “highness” score was measured at 5, 15, 30, 45, and 60 minutes and then every 30 minutes for an additional 3 hours. Cognitive testing was performed at 5 and 30 minutes and then every 30 minutes for an additional 3 hours. The primary analysis compared differences in spontaneous pain over time between doses using linear mixed effects models. There was a significant difference in spontaneous pain scores between doses (P < .001). Specific significant comparisons were placebo versus low, medium, and high doses (P = .031, .04, and <.001, respectively) and high versus low and medium doses (both P < .001). There was a significant effect of the high dose on foam brush and von Frey evoked pain (both P < .001). There was a significant negative effect (impaired performance) of the high dose on 2 of the 3 neuropsychological tests (Paced Auditory Serial Addition Test, Trail Making Test Part B.

The full results of this study have been published in the Journal of Pain.

ABSTRACT:

Neuropathic pain is caused by an insult to the nervous system and accounts for 25-50% of all pain clinic visits. Excluding low back pain, diabetic peripheral neuropathy is the most common neuropathic pain syndrome with an estimated prevalence of 600,000 cases in the United States. There are only 5 medications approved by the FDA for the treatment of neuropathic pain with only 2 out of the 5 approved for the treatment of diabetic peripheral neuropathy. Currently, there is a desperate need for more therapeutic agents for the treatment of neuropathic pain. We propose to use painful diabetic peripheral neuropathy (DPN) patients to study the efficacy of inhaled cannabis on neuropathic pain. We will enroll 20 subjects with each subject acting as their own control; receiving both placebo and three doses of inhaled aerosolized cannabis (low, medium, and high) in random order each separated by at least two weeks. Subjects will be assessed for reduction in pain, changes in normal sensation, changes in cognition, and effects of cannabis on experimentally induced pain. Our hypothesis is as follows:

  1. Cannabis will result in a dose dependent decrease in the spontaneous pain and qualitative pain descriptors.
  2. Cannabis will have no effect on acute sensory thresholds as measured by the QST.
  3. Pain relief will occur at cannabis doses that do not significantly affect cognitive function.

Cannabis will decrease experimental pain as measured by the BTS. The effect on the BTS will correlate with the decrease in spontaneous pain of DPN.

PUBLICATIONS:

Type:

Title:

Meeting Abstract Wallace MS, Atkinson J, Gouaux B, Marcotte TD, Umlauf A. Effect of smoked cannabis on painful diabetic peripheral neuropathy. 32nd Annual Meeting of the American Pain Society. May 14–17, 2013.
Journal Article Wallace MS, Marcotte TD, Umlauf A, Gouaux B, Atkinson JH. (2015). Efficacy of Inhaled Cannabis on Painful Diabetic Neuropathy. J Pain. 2015 Jul;16(7):616-27. doi: 10.1016/j.jpain.2015.03.008. Epub 2015 Apr 3.

Inconsistent, inaccurate information hinders medical cannabis’ potential to ‘revolutionize’ health, wellness

Robert Solomon, Healio, October 30, 2019

The full impact of legalizing medicinal cannabis in some parts of the U.S. is hindered by inaccurate, inconsistent information, according to a panelist at the OCTANe Medical Technology Innovation Forum.

Nearly three dozen states have legalized some form of medicinal cannabis. But those laws are not universal in their language, according to Governing.com, a website that covers politics, policy and management. In addition, cannabis is on the Drug Enforcement Administration’s Schedule I list — meaning it has no currently accepted medical use, high potential for abuse and risk for arrest with use.

“We don’t know what we’re really regulating on cannabis at this point,” Robert Solomon, JD, MA, co-chair of the University of California at Irvine’s Center for the Study of Cannabis, told attendees. “We haven’t come to grips with a fact-based analysis” that answers the questions 'What’s our goal? What’s our point?’ So, we have come up with this mish-mash of incentivizing selling but dis-incentivizing growth.”

Read the story here


UC San Diego’s Center for Medicinal Cannabis Research Awards Grants for Five Novel Studies

Scott LaFee, UC San Diego News Center, October 10, 2019

The Center for Medicinal Cannabis Research (CMCR) at University of California San Diego School of Medicine, the nation’s oldest research center for scientific inquiry into the safety and efficacy of cannabis, has announced $3 million in research grants to explore new applications of cannabis for a number of novel medical applications.

The grant funding, to be allocated to five California-based research teams, will be used to study the efficacy and safety of medical cannabis as both a supplementary or alternative treatment for schizophrenia, rheumatoid arthritis, insomnia, alcohol dependence and anxiety linked to anorexia.

Read the rest of the story here


Cannabis Research Buds Out in New Directions, Arthritis to Insomnia

Debra Kamin, This Week at UC San Diego, October 10, 2019

With 33 states and the District of Columbia having legalized medical marijuana, it was inevitable that there would be much talk of its therapeutic benefits, real or imagined. But lost in the equally inevitable hype has been hard scientific proof.

For almost two decades, the Center for Medicinal Cannabis Research (CMCR) at UC San Diego has been conducting such research, for much of that time largely alone and often, given the controversial nature of the subject, with limited resources. But times are changing, and CMCR recently announced a first wave of five new grants worth a total of $3 million to explore the efficacy and safety of medical cannabis as a supplementary or alternative treatment for schizophrenia, rheumatoid arthritis, insomnia, alcohol dependence and anxiety linked to anorexia.

Read the rest of the story here


San Diego schools look to take mystery and misinformation out of medical marijuana

Jared Aarons, ABC 10News San Diego, September 10, 2019

Starting this fall, the Pacific College of Oriental Medicine is offering the first-ever certificate program specializing in medical marijuana.

The three-semester class promises to teach health care professionals the basics of medical cannabis, so they can begin to use it in their practice.

"We thought it was important for health care professionals to have objective information about medical marijuana," says school President Jack Miller.

Miller says part of the program's purpose is to help dispel some of the myths surrounding medical marijuana.

Read the rest of the story here


CMCR announces $3M in new research grants to California investigators

The Center for Medicinal Cannabis Research (CMCR) at UC San Diego has been a leader in medical marijuana research since 2000. In the past CMCR has allocated funds to investigators in California to conduct some of the first proof of principle clinical trials of cannabis in neuropathic pain and multiple sclerosis.

With the recent allocation of new funding to CMCR as part of Proposition 64, the CMCR has launched a new wave of grant applications aimed at examining both the efficacy and safety of medicinal cannabinoids. CMCR issued a call for applications to investigators in California in April 2019, received 66 letters of intent from 19 California institutions, and invited 26 applications for primary and pilot studies. Based on external peer review, advice of the CMCR’s National Advisory Council, and rating of attentiveness to CMCR priorities, the Center has selected 5 studies for funding this year. The studies to be funded are listed in the table below.

Study title Principal Investigator
Full funding amount
Effects of Cannabidiol (CBD) versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action Kristin Cadenhead, MD (UC San Diego)  $825,000 
Therapeutic Response of Cannabidiol in Rheumatoid Arthritis Veena Ranganath, MD (UCLA)  $825,000
Cannabidiol for Sedative/Hypnotic-sparing Management of Insomnia in Adults Mariana Cherner, PhD (UC San Diego)  $825,000
Cannabidiol as a Strategy to Treat Alcohol Dependence Giordano de Guglielmo, PhD (UC San Diego)  $300,000
The Role of Cannabidiol (CBD) in Regulating Meal Time Anxiety in Anorexia Nervosa: Safety, Tolerability and Pharmacokinetics Emily Gray, MD (UC San Diego)  $300,000

CMCR anticipates issuing a new call for applications in 2020.

Congratulations to the new CMCR Investigators!

- Igor Grant, MD, Director


Robert Fitzgerald, Ph.D.

Senate Caucus on International Narcotics Control

(October 23, 2019)


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


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