Summary: Stars and Stripes speaks to marijuana researcher and Principal Investigator Sue Sisley, M.D., of MAPS’ ongoing clinical trial of smoked marijuana as a potential treatment for symptoms of PTSD. Currently, the trial has 20 military veterans enrolled and needs 56 more veterans suffering from PTSD. “This is the first randomized, controlled trial in the world looking at cannabis for PTSD,” explains Sisley. “Hopefully, we’ll be able to finally answer the question, ‘Does cannabis help with PTSD?’ That’s our goal. That’s why we’ve been fighting so hard to get this underway.”
Originally appearing here.
The waiting room at the Scottsdale Research Institute in Arizona could be any doctor’s office, except for the faint smell of marijuana.
The scent is the only indication that the small space, inside a nondescript gray building in an industrial park on Phoenix’s northern border, is home to a groundbreaking scientific study that could have far-reaching effects. When it’s over, researchers aim to have a definitive answer of whether marijuana effectively treats post-traumatic stress disorder.
The study’s subjects – and its biggest champions – are veterans.
“This is the first randomized, controlled trial in the world looking at cannabis for PTSD,” said Dr. Sue Sisley,the psychiatrist running the study. “Hopefully, we’ll be able to finally answer the question, ‘Does cannabis help with PTSD?’ That’s our goal. That’s why we’ve been fighting so hard to get this underway.”
After seven years of struggling to gain approval from the U.S. Food and Drug Administration and Drug Enforcement Agency, of starting the institute, of finding funding and a landlord willing to rent them space, the study has finally started.
It’s launching at a time when veterans have been at the center of a national conversation on medical marijuana. The American Legion is attempting to apply political pressure to support marijuana research, and just yesterday, Department of Veterans Affairs Secretary David Shulkin said at the White House that he was open to looking at – and learning from – any evidence marijuana could be used to treat veterans.
Still, researchers are fighting through potential setbacks.
They’re clamoring for participants after Johns Hopkins University in Baltimore dropped out of the study in March, transferring their half of the work to the small team in Phoenix. Meanwhile, the VA is not allowing researchers to recruit volunteers at the Phoenix VA Medical Center, citing federal law.
While the government-provided marijuana used in the study is adequate — if not the potency researchers hoped for — Sisley compared it to “trying to cook a four-star meal using Vienna sausages.”
In the last three months, the busiest for the study, Sisley has continued to treat patients at her private practice. She’s gained prominence in the medical marijuana field and maintains a full slate of interviews and speaking engagements, around the United States and internationally. In the middle of it all, she received news that she’s adamant won’t slow her down — in April, she was diagnosed with breast cancer.
“I have my own medical practice, all this stuff going on, but there’s no question this is going to be my top priority for the next two years,” Sisley said of the study. “There’s no time to slow down. This work is too important.”
‘Nothing to lose’
Sisley’s interest in working with veterans stretches back to the late 1990s, when she was a resident at the Phoenix VA hospital. Later, she’d continue to treat veterans, among other patients, at her private practice.
About 10 years ago, she began witnessing the suicide epidemic among veterans first hand.
“I eventually started to see that a lot of these veterans were not responding to conventional medications, and then I began seeing a lot of deaths in my practice,” she said. “These were people who had already been through the gauntlet of medications and nothing had helped.”
According to the latest available VA data, an average of 20 veterans died from suicide each day in 2014.
Some of the veterans Sisley treated told her marijuana helped alleviate their symptoms of PTSD – feeding her curiosity into studying its effects. In the following decade, Sisley – a Republican who says she’s never tried marijuana — would become an outspoken proponent of marijuana research.
Veterans who advocate for medical marijuana quickly took notice. And now, they’re hopeful Sisley’s study will legitimize what they’ve known for years.
Kim Petters, a 35-year-old mother of four, is one of those veterans.
Petters, who served in the Air Force for 10 years, was diagnosed with PTSD and medically retired. She spent four years taking anti-depressants and anti-anxiety medication, as well as prescription sleeping pills.
The medication took a toll, mentally and physically. Other veterans turned her onto marijuana.
“With the pills, before you know it, you’re worse than you started,” Petters said. “I felt like I really had nothing to lose.”
She tried marijuana and used it to gradually stop taking her other medications. But Petters didn’t have legal access to it. Delaware law requires a psychiatrist to sign an application to use marijuana as a treatment for PTSD. Petters searched the state for eight months before finding a psychiatrist willing to sign.
The situation prompted her to create the Women Veterans Collective and join with other grassroots organizations in Delaware to draft legislation for easier access to marijuana. Their bill, which would allow any physician – not just a psychiatrist — to verify an application for medical marijuana, passed the Delaware Senate on May 19.
If the legislation passes the state House, it would be a victory for veterans in Delaware, Petters said, but it won’t be enough for veterans in the bigger picture. For that, Petters has her eye on Sisley’s study.
“It’s been hard,” Petters said, pausing to sigh. “We’ve been waiting on her [Sisley’s] study, and she keeps hitting roadblock after roadblock.”
60 more vets
One afternoon in May, following a DEA inspection of the clinic, two veterans enrolled in the study were going through four-hour, FDA-required introductory sessions at the Scottsdale Research Institute. In separate rooms fixed up for comfort — with couches, televisions, a PlayStation and shelves holding dozens of games and DVDs — they smoked marijuana from pipes. Their vitals were checked every half-hour to ensure they were responding well.
At the same time, the small staff was busy screening other veterans to participate in the study. Veterans come in, sign a 20-page consent form and answer a series of questions.
There were more veterans in the office than employees.
“Every day we’re screening patients,” Sisley said. “All day, every day. We’re calling veterans all the time.”
The first veteran was enrolled Feb. 3. As of May 23, researchers had received calls from 1,300 veterans looking to volunteer. Of those, 200 went through telephone screenings and 16 were enrolled.
The Multidisciplinary Association for Psychedelic Studies in Santa Cruz, Calif., is administering the study. About 5,000 more contacts are needed, officials say, along with 950 phone screenings to find 60 more veterans for the study to be statistically significant.
The team in Arizona
was forced to quicken its pace when Johns Hopkins dropped out, leaving the team without 38 veterans the university promised to enroll.
Johns Hopkins said that its goals were not in alignment with MAPS. The decision came after MAPS spoke out against the poor quality of government-provided marijuana and the National Institute on Drug Abuse’s monopoly on growing marijuana for scientific study.
“We’re focused on reforming public policy and doing quality science, and they’re focused strictly on the science, which is fine,” Sisley said. “Because of the blockades to this research, we’ve been forced to become activists, but we didn’t want that role. I just wanted to do the study. Even though I was forced to become an activist, I’m not pro-cannabis. I’m pro-research.”
Researchers have a small pool of veterans to recruit from for the study.
Participants must be diagnosed with PTSD and are required to meet with doctors 10 times over 18 weeks. They have to live within 50 miles of the Phoenix facility.
The research tests different potencies of marijuana – all weaker than what’s available in Arizona commercially — and some veterans will receive a placebo.
Because Arizona has legalized the medical use of marijuana, some veterans going through the screening process have access to it. Sisley says some vets haven’t been willing to give up the marijuana they have to smoke only what researchers give them.
The location that Sisley sees as the biggest recruitment site, the Phoenix VA hospital, is off-limits. Sisley believes vets there could be trying and failing with conventional treatment methods and would be open to the study.
“The Phoenix VA has continued to block our recruitment and are unapologetic about it,” she said.
Federal law currently prohibits the VA from providing or researching marijuana – regardless of state laws.
A MAPS spokesman said the organization didn’t believe that the VA was intentionally impeding their trial.
Last year, Congress first approved, then removed, a measure from the VA funding bill that would allow VA doctors to discuss marijuana as a treatment option in states where it’s legal.
“Leadership at the Phoenix VA Health Care System advised Dr. Sisley that, in accordance with federal law and VA policy, they could not refer patients to the research project,” a VA spokesman said in a statement.
An unlikely ally
Through their work, the researchers and other medical marijuana advocates have gained an unlikely ally: the American Legion. Near the end of May, the organization was attempting to arrange a meeting with Sisley and the VA central office staff in Washington to discuss the issue with the Phoenix VA.
With its connections in Washington and network of 2.2 million veterans across the country, the American Legion is the group best-positioned to help reduce the stigma and further the cause of medical marijuana, Sisley said.
“The efficacy of the Legion in this whole effort – it hasn’t even been fully realized yet,” she said.
The Legion decided in August 2016 that it would advocate to remove marijuana from the list of Schedule I drugs, which, along with heroin, LSD and Ecstasy, are designated as having no medical use.
The organization is attempting to wield some of its political influence — with the VA and with President Donald Trump.
The Legion had its first in-person meeting with Trump on March 17, when he met with representatives from 10 veterans groups. That meeting was followed by others between veterans organizations and White House staff.
On March 30, the American Legion sent a request to the White House seeking its first one-on-one meeting with Trump – specifically to discuss alternative treatment for veterans, namely marijuana. By the end of May, the Legion had not received a response. The White House press office did not respond to Stars and Stripes’ requests for comment.
“We’re going to ask what it would take to change the administration’s policy on cannabis,” said Louis Celli, national director of veterans affairs and rehabilitation at the Legion. “We want to let the administration know that because we care about our veteran suicide rate, because we care about the veterans who are disabled because of the stressors they’ve endured, it’s important to us we try to make them as whole as possible through any means necessary.”
Joe Plenzler, communications director for the American Legion, said he thought Shulkin’s comments Wednesday could help advance their cause.
“I believe everything that could help veterans should be debated by Congress and medical experts,” Shulkin said. “If there is compelling evidence that is helpful, I hope the people look at this and come up with a right decision, and we will implement that. There may be some evidence this is beginning to be helpful.”
The Legion’s decision in August drew widespread attention to the organization, partly because of the perception that the Legion is conservative. That perception isn’t wrong, Celli said.
Celli concedes he was “very skeptical” when he received a cold call in 2015 from veterans wanting the organization to support medical marijuana. The veterans knew the American Legion had clout on Capitol Hill, and they thought they could make progress with support from a major veterans service organization.
“Immediately, the first thing in my head was, ‘This isn’t going to go anywhere,’” Celli said. “I was absolutely convinced – mistakenly convinced – our organization was going to be too conservative to be open to having the conversation. I just didn’t think they would even consider it.”
Celli served 22 years in the Army, and he’s a former sheriff’s deputy. He knew little about how marijuana was used medically.
In the months after the call, a few things convinced him: a column by former Navy SEAL Nick Etten that said every veteran deserves access to medical marijuana; a CNN special with Dr. Sanjay Gupta about marijuana’s effects on children suffering seizures; and a presentation from Sisley.
“I wanted to make a good-faith effort, an attempt to see if there’s anything to this,” Celli said. “That’s when I found Sue Sisley. She already had a well-developed presentation she shared with me. After I looked at it, I was sold. At that point, I thought there was really an opportunity for science here.”
Sisley would make that presentation three more times, first to the Legion’s 15-member PTSD and traumatic brain injury committee, and then to a commission of 150 members.
She received only positive feedback, Celli said.
“At this point, I knew we were actually onto something as an organization,” he said.
The Legion’s annual convention in Cincinnati at the end of August 2016 drew members from posts across the country. It was used as a campaign stop by Trump and former Democratic presidential candidate Hillary Clinton, and it’s where thousands of veterans voted to take up cannabis research as a priority.
Sisley was told that with the presidential candidates there, she had no guarantee of getting on the main stage. On the convention’s last day, she was squeezed in for five minutes between two other speakers.
Afterward, the crowd quickly voted on – and unanimously approved – the resolution.
Still, as Celli puts it, the Legion is “not advocating for bongs at the VA.”
The organization is looking at marijuana as a possible solution to combat the opioid epidemic. Accidental deaths due to overdose have reac
hed a high in the U.S., and it’s largely driven by opioid addiction, according to the American Society of Addiction Medicine. Information from the VA in 2014, states veterans are twice as likely to die from an accidental overdose than non-veterans.
The VA in recent years has been attempting to curb opioid prescriptions by making alternative treatments for chronic pain more accessible, including chiropractic care, acupuncture and yoga.
“We’re talking about the federal government, about physicians and scientists being able to research a new drug,” Celli said. “We know opioids and narcotics are not the answer. We believe it’s the government’s responsibility to seek out what those long-term solutions are, and we want to work with the VA to try to help them open new study paths and alternative and complimentary therapies. Cannabis could be one of them.”
AMVETS, another of the country’s largest veterans organizations, has also issued its support for medical marijuana. Through a resolution, it called on the VA to provide access to marijuana for veterans in states where its legal.
A question of quality
In addition to asking for marijuana’s reclassification, the Legion’s resolution hit on another controversial topic – the federal government’s monopoly on marijuana production for scientific research.
For decades, all of the marijuana used for clinical research in the U.S. has come from a single source — a well-secured University of Mississippi farm, run by the National Institute on Drug Abuse.
The DEA announced in August that it intended to end that monopoly.
The Legion’s resolution urged the DEA to license privately funded medical marijuana operations to expand marijuana research.
In a document explaining its decision, the DEA said there has been increased interest from researchers to study the chemicals unique to marijuana, called cannabanoids. Some studies have indicated that cannabanoids could be used to treat seizures and other neurological disorders.
“A growing number of researchers have expressed interest in conducting research with extracts of marijuana that have a particular percentage of CBD and other cannabinoids,” the DEA wrote in the document, published on the Federal Register. “DEA fully supports research in this area.”
Scientists have found more than 100 cannabanoids in marijuana. Allowing more production sites means researchers may be able to produce and study specific strains of marijuana to determine whether certain cannabanoids treat certain ailments.
The current situation – in place since 1968 — is limiting.
Sisley waited 20 months to receive the shipment of marijuana to use in the MAPS study. She and Kady Bentz, a research laboratory associate, recalled receiving it in a large Styrofoam box in the mail, with the marijuana wrapped in gallon-sized Ziploc bags.
“When we received the product from NIDA, it was a fun day,” Bentz said. “We were excited.”
The marijuana – loose, not on buds sticky with THC-rich resin, as marijuana consumers may be familiar with — wasn’t as potent as MAPS had requested. Researchers sought for the most potent strain to have 12 percent THC, the compound that gets users high. That amount of THC is far lower than what’s available at commercial dispensaries in Arizona.
In Sun City, about 13 miles west of the Scottsdale Research Institute, a half-dozen people inside the licensed marijuana dispensary White Mountain Health talked with “budtenders” about the strains of marijuana available. Behind a glass counter were dozens of varieties of edibles, THC-infused sodas, cannabis topicals and bubble baths.
The marijuana contained about 20 percent THC, said Jordan Edelstein, who helps run the dispensary.
“If I was only selling 12 percent TCH to patients, they would be very, very disappointed,” he said.
The MAPS study intends to replicate real-world use of marijuana, though the potency is lower than what veterans could find elsewhere.
Bentz takes the marijuana from the Ziploc bags and repackages it into small jars, then weighs, dates it and labels it with a veterans’ subject number before distributing it. The participants are allotted 1.8 grams each day, but they can choose how much to smoke.
“They can smoke it in response to symptoms, or if they’re anticipating symptoms,” she said. “They’re completely empowered.”
For now, Sisley is happy to have any marijuana available to study. And the DEA’s announcement in August gave her some optimism – though she’s cautious about how long it will take to award new licenses to grow.
She plans to apply for a license to produce marijuana.
“I think we can do better,” she said. “Imagine if we had access to all types of cannabis that aren’t available through the University of Mississippi. That would create a renaissance of cannabis research in this country. We could answer legitimate clinical questions about, ‘How does cannabis work?’ and ‘What strains are best for what illnesses?’ That’s what we’re missing now.”
‘A lot of work to do’
MAPS, and Sisley, received approval from the FDA in 2011 to do their study.
Two years later, the Colorado Department of Public Health and Environment granted $2 million to enable it to happen. Around the same time, her sudden termination from the University of Arizona — which she maintains was prompted by her interest in studying marijuana — drew nationwide attention.
The DEA gave its approval for the study in spring 2016.
Sisley described the past seven years as a “saga.” She worries the barriers that she and MAPS have faced could deter other researchers – underscoring the need for change in marijuana policies at the federal level.
“No scientists who have seen what we’ve been through want to embark on this work,” she said.
It will be two years before MAPS has gathered evidence and can publish its findings.
Sitting in the institute’s waiting room May 2, Sisley described her days in the clinic – with the study underway — as “pure joy.”
“I walk in here every day and feel so honored,” Sisley said. “I can’t even tell you … just finally seeing the study implemented and the gratitude of these veterans.”
One month after the first veteran received marijuana for the study, Sisley was diagnosed with breast cancer. On May 3, she had surgery and was walking laps around her hospital unit the next day, ready to return to work.
“I’m so determined to get out of this hospital,” she said over the phone that day. “There’s a lot of work to do.”