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.

San Diego company testing marijuana-derived multiple sclerosis therapy

Gary Robbins, San Diego Union Tribune, October 10, 2018

Emerald Health Pharmaceuticals of San Diego has begun using a marijuana-derived therapy to experimentally treat small numbers of people who suffer from multiple sclerosis and scleroderma, a pair of autoimmune diseases.

The small, phase 1 safety trial involves CBD, a compound found in marijuana. CBD has caught the attention of researchers because it does not get people high, and it has anti-inflammatory properties.

The trial is meant to determine whether the therapy is safe, what dose should be used, and if there are any side effects or related problems.

Emerald Health says it also is developing another non-psychoactive compound found in marijuana — CBG — for possible use in treating patients with Huntington’s disease and Parkinson’s disease.

UC San Diego is preparing to use CBD in a clinical trial that’s meant to people who suffer from epilepsy.

Read the story here


DEA slowly takes steps to affirm the medicinal value of marijuana

Gary Robbins, San Diego Union Tribune, October 2, 2018

Scientists and patients who've long held that marijuana can be used to treat illness and disease are finally getting some backing from the federal government.

The Drug Enforcement Agency currently lists marijuana as a Schedule 1 drug, meaning that it has no known medical use and a high potential for abuse.

But in a very narrow ruling, the DEA recently said that patients who suffer from two specific types of epilepsy could benefit from taking Epidiolex, a new anti-seizure medication derived from marijuana.

Epidiolex largely consists of cannabidiol, or CBD, a compound in cannabis that does not get people high.

The DEA decided to classify Epidiolex as a Schedule 5 drug, which would rank it with cough medicines.

The move has caused some confusion. The Union-Tribune sought clarity from Dr. Igor Grant, a psychiatrist who helps lead UC San Diego's Center for Medicinal Cannabis Research.

Read the interview here


Study to Examine Possible Effects of Cannabis Compound for Common Movement Disorder

Press Release, UC San Diego Health, September 18, 2018

Researchers at University of California School of Medicine are preparing to launch a novel clinical trial to examine the safety, efficacy and pharmacological properties of cannabis as a potential treatment for adults with essential tremor (ET). Currently, ET is treated using repurposed medications originally developed for high blood pressure or seizures. Surgery is another option.

Scheduled for early 2019, the phase I/II trial will assess efficacy and tolerability of an oral cannabis formulation comprised of cannabidiol (CBD) and low-dose tetrahydrocannabinol (THC). Researchers say it will be the first time this combination has been studied for treatment of ET.

“This study will provide key insights,” said Fatta Nahab, MD, neurologist at UC San Diego Health and associate professor of neurosciences at UC San Diego School of Medicine. “If found to be safe and effective, cannabis would not only serve as an exciting new addition to the limited treatment options currently available for patients with ET, but it might also provide scientists with new insights on essential tremor.”

Read the full press release here


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