PHOENIX — 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 reached 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.