Summary: Health News Colorado reviews the recent progress of MAPS’ FDA-approved study of medical marijuana for PTSD in veterans, detailing how $2 million in government-funding from the Colorado Board of Health has helped secure a future for the study. The article features an interview with Marcel Bonn-Miller, Ph.D., one of the study’s Principal Investigators, about MAPS’ upcoming marijuana study, featuring an overview about the study protocol and how the research team is preparing for the study.
Originally appearing here.
The young veteran who served a year of combat duty in Afghanistan struggled to walk to a microphone, then shook as his spoke.
He wore a chain like a dog tag with the number 22 to symbolize the number of veterans who kill themselves each day.
“We need to use every tool we can to save these young men and women’s lives, anything to relieve the symptoms of PTSD,” Chris Latona told the Colorado Board of Health on Wednesday.
“This is just a continuous battle for years and years and years,” said Latona who later shared the story of his own horrific battle with PTSD, his decision to quit using other pain medications and move from Florida to Colorado to take marijuana so he can sleep better and calm frequent muscle spasms.
“We’re at 8,000 deaths a year. We can’t afford to lose any more of these patriots at their own hands. You live with these things in your head. Now we need care at home,” Latona said.
Minutes later, the board unanimously voted to support spending about $7.6 million from medical marijuana licensing fees on eight research projects aimed at studying whether marijuana can help treat various health conditions from PTSD to child epilepsy.
After the board voted, supporters leaped to their feet and cheered loudly in a hearing room at the headquarters of the Colorado Department of Public Health and Environment.
Marcel Bonn-Miller was not in the room at the time. He’s a research scientist in the Department of Psychiatry at the University of Pennsylvania’s Perelman School of Medicine. He’ll be leading the two largest grants that the board approved, both exploring the effects of marijuana use on PTSD.
First clinical trials of marijuana and PTSD
Bonn-Miller, who doesn’t take sides on whether marijuana will be beneficial or not, said the research projects are highly significant and the first of their kind in the world.
“It’s really ground-breaking. One of these is the first randomized, controlled clinical trials of marijuana as a treatment for PTSD,” Bonn-Miller said.
There have been some small studies on the use of marijuana for PTSD in Israel, but they weren’t as scientifically rigorous as the ones just approved in Colorado, Bonn-Miller said.
The name of the sponsoring institution for one of the PTSD studies — the Multidisciplinary Association for Psychedelic Studies — sounds like a remnant from the days of LSD tests chronicled in Tom Wolfe’s “Electric Kool-Aid Acid Test.”
In fact, Bonn-Miller said both PTSD studies will result in very serious science.
He became interested in the use of marijuana for PTSD when he noticed how frequently veterans were turning to it on their own. Some of his past research focused on how patients who want to stop using marijuana can give it up.
“This is a different realm, the other side of the equation,” Bonn-Miller said. “This is looking specifically at the nuance of administration for symptom relief.”
One of the studies, which will cost $2 million over three years, is a randomized, controlled trial that will gauge the effects of different concentrations of marijuana on 76 veterans. The marijuana will come from the federal government’s National Institute on Drug Abuse. Scientists there will grow different strains of marijuana for the study.
The first will have a high dose of THC and low CBD. The second will be high-CBD, low-THC. The third will contain equal parts of both. And the fourth will be a placebo version of marijuana.
The people in the study will smoke the marijuana. Bonn-Miller said researchers decided to focus on smoked marijuana because that is the most common way people use it and because the effects from edibles are so different from smoked marijuana.
“We’re going to have veterans come in and we’re going to look at the effects,” Bonn-Miller said. “It’s really beautifully designed, very experimental.”
Study workers will have to keep very tight controls on the marijuana used in the study.
“We have to be very, very diligent about tracking the stuff. We’ll be videoing use, weighing the bags and instituting measures to discourage diversion,” Bonn-Miller said.
They also want to make sure the veterans don’t use other street weed at the same time.
“Since we’re supplying it, they shouldn’t have a need to go somewhere else,” he said.
During the first round of testing, veterans will use one of the four strains of marijuana for three weeks. They will decide themselves how much they want to smoke and researchers will carefully track both the use and how the veterans are doing with a variety of symptoms ranging from sleep to depression to suicidal thoughts. The veterans will then stop using marijuana for a period of time and during a second round, each test subject will again get one of the strains. During the second round, researchers knocked out the placebo to ensure that no study subjects get the placebo twice.
Based on some previous studies in rats, Bonn-Miller thinks the researchers may find some benefits of marijuana for people with PTSD. But, of course, rats are different from people, and only time will tell how the results turn out.
“We don’t have a big expectation on the strain type. There’s some potential that high-CBD may be most beneficial,” Bonn-Miller said.
But, he said, the results will speak for themselves.
Veterans in the study will report on how they’re doing and workers will also use objective monitoring. So with sleep, for instance, the veterans will give their impressions of how they’re sleeping and also will wear sleep-tracking devices.
In terms of depression, the veterans also will be closely watched.
“We might see an effect for suicide,” Bonn-Miller said. “Many folks with PTSD have that as a real concern.”
Independent raters will be looking at all sorts of other issues associated with PTSD like hyper-arousal symptoms. And they’ll be monitoring physical and mental health, including the impact of smoked marijuana on pulmonary function.
After the initial period during which the veterans will be using the various strains, researchers will be doing extensive follow-up.
“We won’t know until the third year of the grant how things are shaking out,” Bonn-Miller said.
The second research project, which was awarded $1.1 million on Wednesday, will look at people who experience PTSD from a variety of causes. Some, like Latona, may be coping with the aftermath of war, while other study subjects could be suffering as a result of a rape or another traumatic incident.
Bonn-Miller said the two studies are separate, but complement one another.
The first study could answer a great deal about different strains of marijuana that people are using. The second is an observational study over time to see what’s happening on the ground with people who use and those who don’t.
Researchers will be finding people with PTSD, half of whom are using marijuana for their symptoms, and half
of whom are not.
They will be trying to find very similar people in both groups. So, if a marijuana user is a male and suffering from PTSD as a result of war, researchers will work to find another man who is also a war veteran and who is not initially using marijuana.
Some of the people in the study who are not using marijuana may choose to use it over time or may stick with the treatment regimen they were previously using. Those subjects would not know that they’re participating in a marijuana study so they would not be encouraged to use it.
Bonn-Miller deliberately designed the second study to try to capture what’s actually happening on the ground in Colorado.
“It would be nice to know what people in Colorado are using who have PTSD,” Bonn Miller said. “We wanted to track people as long as possible.”
He said researchers will monitor the non-users to see if they start using marijuana during the study. They will record effects on symptoms. Unlike the first study, anyone using marijuana in the second study will be buying their own.
Researchers will then test the strains that the users purchased to monitor the cannabinoid content.
“Then we’ll see how it affects symptoms. We’ll assess them at intake, at three months, at six months, nine months and a year.”
Use, of course, may be fluid and the researchers will study why participants make the choices they do. Altogether, there will be 150 participants, 75 who start as marijuana users and 75 who don’t.
Dr. Hal Wortzel, who works at the Denver VA and at the University of Colorado Hospital, will be helping extensively with the observational study.
Vets, doctors eager for scientific findings
Christopher Latona and other veterans spoke passionately about their desire for the Colorado Board of Health to add PTSD to the list of conditions for which users can get marijuana cards in Colorado.
Board of health members say they are eager to have new science to guide their decisions about PTSD and many other health conditions from Tourette’s syndrome to Krohn’s Disease.
Latona served in Afghanistan for a year from 2009 to 2010 with the 173rd Airborne Brigade, the same unit featured from their service a year earlier in the film “Restrepo.”
In many ways, Latona says Afghanistan reminds him of Colorado with snow-topped peaks, deep river valleys and plenty of farming.
Latona says he came home from the war with PTSD and terrible nightmares.
He recalls when an RPG blew up the Humvee he was riding in. Latona was riding up high, manning the machine gun. The RPG hit the door down low.
“If it had hit a few feet higher I’d be dead,” Latona said.
Nightmares from that incident haunt his sleep. He also can’t shake the image of a buddy who was hurt as Latona watched.
“He got blown up by a 300-pound IED. I watched him walk out of all that dust like a zombie. Your heart sinks,” he said.
That friend survived, but like Latona, is severely injured.
Latona said he has now been diagnosed with a rare but old illness associated with veterans as far back as the Civil War. It’s called “Stiff Person Syndrome.”
Every so often muscle spasms cause stiffening of his limbs and he can’t move.
“I call it getting stuck,” he said.
For a time, Latona used prescription medications for pain. He’s been sober from those for six months and now uses marijuana for a variety of PTSD symptoms. He said he sleeps better after smoking a small amount. He also uses some CBD-THC oil to help relieve the spasms.
He does not view marijuana as a cure for PTSD, but rather as a tonic that can help with painful and debilitating symptoms of the disease.
“When I get a flashback, I smoke. It gives me immediate relief,” Latona said.
He said his fear mechanism sometimes clicks into overdrive.
“It’s like with kids. When you’re in a state of fear for so long and there’s nobody to help you, like a kid who’s crying and no one picks them up and they get asthma from the cortisol,” Latona said. “My body is in a constant fight or flight mode.”
When he feels the stress surging in his body, he said marijuana helps fast.
“It calms your mind. It puts your body in homeostasis,” Latona said. “I suffer from chronic depression, anxiety and the pain from my spasms.
“Two, three, four months ago, I was in a wheelchair,” Latona said.
Now, he can walk short distances, although he also used a wheelchair at Wednesday’s hearing.
Latona was one of several people who cheered when the board approved the research grants.
“I’m hopeful,” he said. “We just broke history. This has never been done in the States.”
As for his personal outlook, Latona remains proud of his service and does not regret his year in Afghanistan.
Still the future looks grim.
Latona is living in a hotel spending his money on marijuana products that the Veterans Administration won’t cover.
“I’ve got back pay. I’m living off savings. Then I’ll be homeless like the rest of these guys.”