Rick Doblin of MAPS Talks Medical Cannabis Trials and a Possible Legalization TimelineNick JikomesMay 18, 2017
Due to the remarkable success of their Phase II studies, MAPS recently received FDA approval to conduct large-scale, Phase III clinical trials for MDMA-assisted psychotherapy for treating post-traumatic stress disorder (PTSD). MAPS has also received FDA approval to study the safety and efficacy of medical cannabis in treating symptoms of PTSD. Gaining government approval for these studies is no easy task—the process is expensive and time-consuming, especially for federally illegal substances.
In the US, research on the efficacy of medical marijuana has moved even more slowly than clinical research on other controlled substances, such as MDMA. The reasons for this stems from the monopoly that the National Institute of Drug Abuse (NIDA) has had on the production of research-grade medical marijuana in the US. As the executive director of MAPS for over 30 years, few people have as much experience navigating the bureaucratic nightmare of US drug law than Rick Doblin.
We caught up with Dr. Doblin to discuss MAPS-funded clinical trials for PTSD, NIDA, the Trump administration, and what the timeline for the end of federal cannabis prohibition might look like.
“Research should be about science over politics, especially when it comes to easing human suffering.”Rick Doblin, Founder and executive director of MAPS
Leafly: How long has MAPS been trying to research medical cannabis?
Rick Doblin: We tried to do work with marijuana back in 1991, and it took me an entire year to find anyone who wanted to do research on it. Nobody wanted to do it because marijuana was monopolized by NIDA and they made it very difficult to get permission to do research looking at benefits–it was okay if you wanted to look at harms.
Did you have any success trying to do medical marijuana research in the 1990s?
Donald Abrams was the doctor who agreed to try to do research. We wanted to study the potential benefit of medical marijuana to stimulate appetite in HIV patients with wasting syndrome, where appetite loss is a huge problem that can cause death. In 1992, he tried to do the research but NIDA refused to provide the marijuana. It was very frustrating.
After 1996, when California and Arizona passed medical marijuana, NIDA was aware that part of the argument for wanting to pass medical marijuana laws was that there was no way through the FDA. It was blocked, politically. NIDA then said to Dr. Abrams, if they gave him a million dollars to do a study, would he change the study so it only looked at the risks of marijuana as opposed to the benefits. They wanted us to exclude HIV patients with wasting syndrome. We just decided to say yes, since it would be somewhere to start.
After finally getting approval to move forward, what happened next?
The study showed that there were no negative drug/drug interactions between marijuana and protease inhibitors, the new drugs to treat HIV. As a secondary outcome, the study did looks for benefits and showed that marijuana increased appetite and weight gain. We then tried to start a study of marijuana in the treatment of migraines. We had FDA and IRB approval but NIDA refused to sell us the marijuana.
Then we tried to study marijuana vaporizers compared to smoking marijuana. It took us seven years of unsuccessful efforts trying to buy ten grams of marijuana from NIDA, which they didn’t sell us, and the firm we were working with gave up.
After going through such a frustrating experience, how did your strategy evolve for getting government approval for medical cannabis research?
It was very important to me to try to open research with marijuana because I want to establish the principle that research should be about science over politics, especially when it comes to easing human suffering. We had had success doing that with MDMA-assisted psychotherapy for PTSD and the FDA agreed. But with marijuana–as long as the repression of marijuana research was still taking place, I felt that things could turn negative when it comes to psychedelics. So, in addition to finding a way to move forward with marijuana politically, we had to think, which kind of patient population, which kind of condition is likely to gather political support to overcome all this resistance? That led to studying marijuana in veterans with chronic, treatment-resistant PTSD.
MAPS has been approved to study the safety and efficacy of medical cannabis to treat symptoms of PTSD. How might medical cannabis be useful as a PTSD treatment?
Marijuana is very helpful for PTSD, but it’s mainly helpful in the sense of treating symptoms. Usually it’s not a cure. One of the big things about PTSD is that people have intrusive thoughts and nightmares. Marijuana can help people sleep through the night, and if you can get good sleep, that’s one of the fundamental healing properties of getting over PTSD. It’s been seven years just trying to get this study approved, so we’re excited to finally move forward.
Last August, the DEA announced its intention to end the NIDA monopoly by granting licensing to additional growers to provide medical cannabis for research. How is this going to affect research?
If there’s one thing I’d like you to emphasize to your readers, it’s that the battle is not won yet, even though the DEA agreed to end the NIDA monopoly. That was announced under the Obama administration. The DEA has not issued any licenses for anyone to grow other than Dr. Mahmoud ElSohly at the University of Mississippi, who grows under contract to NIDA. We have to put political pressure on this NIDA monopoly, because that’s what’s keeping marijuana from being approved as an FDA-approved medicine.
“I think there’s a chance that by 2024 or 2028 that we will have full marijuana legalization.”Rick Doblin
The other key point there is, at this moment, the FDA is our main ally. They’re not pro-marijuana or pro-psychedelics. They’re pro-science over politics and they want to address human suffering. They said–at the meeting back in 1992, actually–that it would be an open door for research on psychedelics, marijuana, and Schedule I substances, but they had to be held at the same standards that the FDA uses for Big Pharma to study any other drug. We said we will accept that challenge, because at least that’s a fair process.
How worried are you about the Trump administration reversing some of the gains that we have made with respect to legal cannabis?
President Trump has said that he’s all about preventing American jobs from moving overseas. Well, we’re taking the entire legal marijuana industry and moving it offshore because of our policies. For example, GW Pharmaceuticals is the largest medical marijuana company in the world–it’s in England. They now have a $2 billion market cap, meaning the stock is worth $2 billion. That’s a company that could have just as easily been in the United States. So, the fact that legitimate, good paying jobs with taxable income–these are arguments we can be using if there is a government crackdown. Now is the time, while the policies are being set, to put a lot of pressure on the Trump administration to not crack down on marijuana.
Now that the Trump administration is in power, how will that affect the timeline for federal legalization of cannabis–or at least re-scheduling it? Or are things completely unpredictable now?
Things are somewhat unpredictable, but I’d like to point out that there were nine states where medical marijuana and legal adult-use marijuana was on the ballot. In six of those nine states, marijuana got more votes than Trump. The Republicans are supposedly big supporters of states’ rights. Whether or not they’ll block marijuana in legal states is unclear, but it would be quite unpopular for them to do that.
Let’s assume there won’t be a crackdown. What’s the timeline looking like for federal legalization, in your opinion?
You’ll get different answers on this depending on who you talk to, but medical marijuana initiatives do much better in presidential election years. That’s when more young people come out to vote, and more people are interested in the election. My guess is that in 2020, we will have additional medical marijuana and legalized adult-use states. So, I think there’s a chance that by 2024 or 2028 that we will have full marijuana legalization. That would be my guess. You’re going to need more states on board before you can convince their members of Congress to vote for federal legalization.
To learn more about MAPS and their FDA-approved clinical trials for PTSD, visit www.maps.org.