Vaporization as a "Smokeless" Cannabis Delivery System

INVESTIGATOR: Donald Abrams, M.D.

STUDY LOCATION: University of California, San Francisco

PROJECT TITLE: Vaporization as a "Smokeless" Cannabis Delivery System

PROJECT TYPE: Clinical Study

STATUS: COMPLETE

RESULTS:

The full results of this study have been published in the journal Clinical Pharmacology & Therapeutics. Below is a brief summary of these results.

The purpose of this study was to evaluate the use of a vaporization system (the Volcano; VAPORMED® Inhalatoren) as a “smokeless” delivery system for inhaled marijuana. The study looked at heating marijuana to form a vapor and then comparing drug levels in the blood to those obtained from smoking an identical amount of marijuana from a cigarette. In addition, we compared the tolerability of the two methods and measured expired carbon dioxide to evaluate whether the vaporizer reduces exposure to respiratory toxins.

Eighteen healthy subjects were recruited and admitted to the inpatient ward of the General Clinical Research Center (GCRC) at San Francisco General Hospital to investigate the delivery of marijuana by vaporization compared to marijuana smoked in a standard cigarette. One dose (1.7, 3.4, or 6.8% tetrahydrocannabinol) and delivery system (smoked marijuana cigarette or vaporization system) was randomly assigned for each of the six study days. The analysis suggests that the blood levels of vaporized marijuana are similar to those of smoked marijuana. However, blood concentrations at 30 minutes after drug administration and beyond were significantly higher in vaporized marijuana as compared to smoked marijuana. In addition, the carbon monoxide levels were significantly reduced with vaporization compared with smoked marijuana. Fourteen participants preferred vaporization, 2 smoking, and 2 reported no preference. No adverse events were observed.

In this study, vaporization of marijuana was found to be a safe mode of delivery. Participants had a clear preference for vaporization over smoking as a delivery system for the marijuana used in this trial.

ABSTRACT:

The Institute of Medicine report on Marijuana as Medicine published in 1999 concluded that "scientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC, for pain relief, control of N & V, appetite stimulation; smoked marijuana, however is a crude THC delivery system that also delivers harmful substances." The report recommended that clinical trials of cannabinoid drugs for symptom management should be conducted with the goal of developing rapid onset, reliable, and safe delivery systems.

Our primary objective in this study is to evaluate the use of a vaporization system (the Volcano; VAPORMED® Inhalatoren; Tüttlingen, Germany; www.vapormed.de) as a "smokeless" delivery system for inhaled marijuana. We will compare plasma levels of delta-9-tetrahyrocannabinol (THC), cannabidiol, cannabinol, and metabolites, including 11-OH-THC, in healthy volunteers after smoking one 3.95% THC marijuana cigarette (using the Foltin puff procedure) to those obtained when the same individual inhales the vaporization product of the marijuana from an identical cigarette processed through the Volcano device. In addition to plasma levels, we will also compare the THC concentration over an 8-hour time period, the subjective high experienced by the patients, and clinical evidence of cannabis effect by evaluating conjunctival hyperemia and heart rate.

We will also compare the tolerability of the two methods of ingestion, and we will measure expired carbon monoxide to evaluate whether the vaporizer reduces exposure to respiratory toxins. Twelve participants will be admitted for a 2-day stay at the General Clinical Research Center (GCRC) at San Francisco General Hospital. They will be randomly assigned to either inhalation of products of a smoked marijuana cigarette or the vaporization products produced by use of the Volcano device. Blood for pharmacokinetic evaluations and measurement of physiologic and psychologic effects of cannabis will be conducted by the GCRC research nursing staff who have been involved in all of our cannabis clinical trials to date. On day 2 of the stay, participants will inhale the alternative product and the same measurements will be obtained. If this study demonstrates that vaporization of cannabis produces significant blood levels and physiologic effects with a tolerable side effect profile, the Volcano may provide a rapid onset, reliable and safe delivery system to be used in future effectiveness studies of medicinal cannabis.

PUBLICATIONS:

Type:

Title:

Journal Article Abrams DI, Vizoso HP, hade SB, Jay C, Kelly ME, and Benowitz NL. (2007). Vaporization as a Smokeless Cannabis Delivery System: A Pilot Study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. Epub 2007 Apr 11.
Meeting Abstract Abrams, D., Vizoso, H., Shade, S., Jay, C., Kelley, M.E., Benowitz, N. Vaporization as a Smokeless Cannabis Delivery System: A Pilot Study. 2nd Annual Meeting of the International Association for Cannabis as Medicine. 2005.

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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


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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.

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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.

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

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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.

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(October 23, 2019)


Igor Grant, MD

Marijuana as Medicine: Can We See Past the Smoke?
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Igor Grant, MD

Introduction/Overview
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Daniele Piomelli, MD, PhD, PharmD

The health impact of cannabis
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Ziva Cooper, PhD

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


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