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Delays may now push Utah-funded marijuana study results past Election Day

FILE - In this June 21, 2018, photo, laboratory manager Emily Savage demonstrates how she uses an instrument to photograph cannabis samples at CW Analytical Laboratories, in Oakland, Calif. Thanks to delays in a federal approval process, research official
FILE - In this June 21, 2018, photo, laboratory manager Emily Savage demonstrates how she uses an instrument to photograph cannabis samples at CW Analytical Laboratories, in Oakland, Calif. Thanks to delays in a federal approval process, research officials now say the results of a study into marijuana's effects on pain may not be available to voters when they go to the polls in November to decide on a medical marijuana initiative.
Jeff Chiu, Associated Press

SALT LAKE CITY — In November, researchers were optimistic that a state-funded clinical study into marijuana's effects on pain would produce some results that could be presented to state lawmakers before the end of the legislative session in early March.

In January, after encountering some difficulty getting federal government approvals for shipment of the drug, the Utah Science Technology and Research Initiative revised its estimate to late June or early July.

Now, thanks to more of the same federal delays, the study results may not be finalized before Utahns go to the polls in November to decide whether to vote for or reject a medical marijuana ballot initiative.

"There may be data available before the vote in November, but it will be close," Ivy Estabrooke, executive director of the research initiative, told the Deseret News.

USTAR, a research and economic development engine organization created by state legislators a little more than a decade ago, was appropriated $500,000 for the study for fiscal year 2018 when lawmakers were finalizing the 2017 state budget.

However, since that time the federal approval process required to obtain the drug itself has been drawn out and has been "quite frustrating," according to Estabrooke.

"The challenges of running a study on a Schedule I drug are just incredible," she said.

Although the researchers on the project "put in their paperwork appropriately" to the Drug Enforcement Administration and the Food and Drug Administration "and everyone else," Estabrooke added, "they just got permission to have the drug shipped (on June 25)."

USTAR has selected University of Utah psychiatry professors Deborah Yurgelun-Todd and Perry Renshaw to lead the study.

"These were researchers who had worked with marijuana before, who had gone through all the processes before, and it still took … close to a year and a half to get through all of the (federal) processes to get a study started," Estabrooke said.

The state of the research into medical marijuana has been a major point of contention in the debate between supporters and opponents of the ballot initiative.

The ballot initiative would allow patients with certain conditions — including Alzheimer's disease, Crohn's disease, multiple sclerosis, post-traumatic stress disorder and HIV — to apply for a card allowing them to legally possess marijuana for medical use.

The Utah Medical Association has opposed the initiative in part because it says there is not enough reliable research into the medical benefits of the whole marijuana plant, what side effects are associated, what types of patients could benefit, or what doses would be appropriate. It also believes the initiative would allow overly broad access that paves the way for recreational use.

But DJ Schanz, the director of the initiative campaign called the Utah Patients Coalition, has previously criticized that characterization and said there are "literally thousands of clinically studied reports" worldwide that analyze marijuana's medical properties.

Schanz has also publicly worried whether the Utah Legislature's request for a USTAR marijuana study is a "smoke screen" or "delay tactic" for state politicians looking to use the effort as a way to say they are paying attention to the isssue of medical marijuana while also promoting the delaying of legalization.

Yurgelun-Todd and Renshaw have previously defended the study's importance to the Deseret News, saying more clinical research needs to explore the effectiveness of marijuana with specified levels of its psychoactive ingredient THC, how quickly treatment might work, what appropriate dosing looks like, and the potential side effects of treatment.

Approval process

Estabrooke said examples of the federal government's requirements include, among other steps, site visits from the DEA "to look at where you're going to hold the drug," and a stringent approval process from the FDA.

Estabrooke said she doesn't take issue with the reasoning behind such requirements, noting she doesn't doubt it is in place because "they're trying to make sure the drug doesn't become available to people who shouldn't have control of it."

However, she added, "We're not going to get more information if we don't allow the information to go forward."

"I do think that if we as a nation are serious about looking up the science behind the use of marijuana, we need more research and we need the processes to be streamlined so that more research can go on in a controlled environment."

Sen. Orrin Hatch, R-Utah, has also criticized the federal requirements on researchers hoping to study marijuana, denouncing them as "regulatory acrobatics."

"Under current law, those who want to complete research on the benefits of medical marijuana must engage in a complex application process and interact with several federal agencies. … The longer researchers have to wait, the longer patients have to suffer," Hatch told the Deseret News in December.

Once the drug arrives from its federally approved source, Estabrooke said, USTAR and its researchers from the U. believe it will require roughly four months to carry out the study and complete an analysis of the results, though that timeline could vary slightly.

"They'll hit the ground running," Estabrooke said.

Subjects who will participate in the study "are in the queue to be tested and they're ready to go" as soon as the marijuana is physically in house, she said.

"My guess is, and it's just a guess, is that it will be here in the next couple of weeks," she said.

Still, she said with some exasperation, her experience so far tells her "my crystal ball is not what it once was."

Chocolate pudding

Even if the study is not completed until after Election Day, however, its findings should still be of strong interest to Utahns, Estabrooke said.

If the initiative has been passed by voters by then, the study findings "will provide insight into efficacy, and that will help individuals and doctors decide whether to use it or not," Estabrooke said, and will also have interesting findings on possible side effects and proper dosing.

"It will still inform the discussion, particularly in … the recommendations for use that come out of it," she said. "We'll have a better informed idea of whether it's truly helping with pain."

The research will consist of randomized, double blind, placebo-controlled clinical trials examining the effects of marijuana on the pain levels of 75 subjects who suffer from chronic pain.

The subjects will each receive one of three different substances. One group will get a treatment high in THC and low in CBD, the latter of which does not have psychoactive effects. Another group will receive marijuana with the inverse: High THC and low CBD. A third group will receive a placebo containing no marijuana.

Estabrooke said there were initially plans to give subjects a capsule, but researchers later decided it would be more effective to provide chocolate pudding, which they expect will do a better job of obscuring whether or not there is marijuana contained in it.

"You want to make sure that the subject is truly blind to it, so you want something with enough paste that you can't tell if anything's mixed in it or not," she said. "Chocolate pudding is a good way to deliver it."

For five days, patients will receive their treatment or placebo, and their pain will be monitored and measured using a brain MRI, a self-reported pain scale, and a cognitive function test.

Estabrooke has previously explained the MRI is useful because it doesn't rely on any self-reporting, and that cognitive function tests can also help as a way to gauge the magnitude of pain's debilitating effects on a person at a given time.