MDMA is going into “Phase 3” Trials for the US Food & Drug Administration
This is something of a seismic shift — or at least the pre-rumblings of a seismic shift — since no one knows how the trials will turn out, and if the FDA will grant MDMA a status upgrade to a prescribable medication. If it does, though, this would be a big deal.
MDMA, a.k.a. 3,4-Methylenedioxymethamphetamine, has been an illegal drug since 1985, classed as Schedule I with “no acknowledged medical uses.” Instead, it is best known as an alias for (technically, an ingredient in) the popular recreational drug Ecstasy or “Molly.”
Interestingly, at the time that MDMA was added to the list of illegal drugs, there was an outcry from many psychiatrists who attested to the usefulness of MDMA in psychological therapies. However, despite some legal back-and-forth, the lack of placebo-controlled studies at that time proving the therapeutic effectiveness of MDMA led to the cementing of Schedule I status (as opposed to Schedule III). And that has remained the situation until the present day.
“MAPS” to the Rescue?
In Episode #99, I spoke with Brad Burge of MAPS, the Multidisciplinary Association for Psychedelic Studies. MAPS’ overall agenda involves broadening the acceptance and effective use of psychedelic compounds, and revisiting and carefully studying MDMA’s usefulness as a therapy against PTSD (Post-Traumatic Stress Disorder) seemed like low-hanging fruit…
Maybe not all that low-hanging, considering the social stigma against “party drugs” and the famously variable effects of psychedelic compounds on the human mind. But it was a place to start, and the effectiveness of MDMA in combination with “guided therapy” sessions was attested to by countless anecdotal reports.
Also worth considering: Severe PTSD can be so unpleasant and incapacitating for its sufferers that almost any therapy with a reasonable chance of effectiveness is worth a try. This fact – and the lack of effective interventions in the current anti-PTSD toolkit – isn’t lost on the FDA.
Dr. Will Van Derveer is one of the psychiatrists participating in MAPS’ study, and in Episode #211, he explains to us both the process that he undertakes with the trial’s PTSD patients, and his personal theories on the complementary use of psychology and pharmacology to treat emotional disorders including PTSD, clinical depression, and more.
According to Van Derveer, the apparent failure of some alternative treatments (e.g. ketamine for clinical depression) to maintain lasting benefits is likely because under those study protocols, the drug was applied “in a vacuum” without the guided emotional context provided by the psychiatric professional.
It’s a fascinating discussion, touching on dark areas in the human psyche — but also offering the possibility of new reasons for hope, if tools like psychiatrically-administered MDMA live up to their apparent promise.
Episode introduction: MDMA vs. PTSD.
This Week In Neuroscience: Nicotine withdrawals, working memory, and rewards.
5-Star review shoutouts.
SDS news and updates.
Guest introduction: Dr. Will Van Derveer.
Increased talk about PTSD in recent years.
Mainstream psychiatry and the ongoing use of medication.
Application of functional medicine principles in psychiatry.
Individual differences in how well the treatments work.
Abilities of participants to get off of their medications.
Ketamine treatments for addressing the suicidality that can spike up when people go off their medications.
The current state of research on using MDMA as a therapeutic intervention against PTSD.
The legal jurisdiction of MDMA.
Current state of psychiatry and the failure to understand the mechanisms of the diseases that psychiatry treats.
Changes to the research protocol in Phase 3.
Looking back to Phase 2.
Altered states of consciousness.
Might there still be benefits to be gained from MDMA for someone who is not pathological?
Ensuring that the therapists do a good job with the therapy.
What are some other possible front-runner alternative therapies for PTSD?
Ruthless Listener Retention Gimmick: Individual differences in sleep deprivation.