Randomization Masking And Bias Minimization
Participants were randomized in a blinded fashion and were allocated 1:1 to either the MDMA-assisted therapy group or the placebo with therapy group. Randomization was stratified by site and occurred following enrollment confirmation . Randomization was managed via an interactive web randomization systemITClinical IWRS, version 11.0.1 based on a centralized randomization schedule developed by an independent third-party vendor to maintain blinding. Participants, site staff and the sponsor were blinded to participant group assignment until after the database was locked.
An inactive placebo with therapy was utilized as the comparator to isolate the efficacy of the MDMA itself. Although low-dose MDMA improved blinding in phase 2 studies, it led to decreased effectiveness compared with an inactive placebo in a PTSD population, making it easier to detect a difference between the active and comparator groups. The use of inactive placebo also allows for uncontaminated comparison of safety data between groups. Therefore, an inactive placebo was determined in partnership with the FDA as a more conservative statistical comparison, and the study utilized observer-blinded efficacy assessments to minimize bias in efficacy measurements.
The Modern Concept Of Post
The diagnosis of what is now accepted as Post Traumatic Stress Disorder has changed over the years as we have gained a better understanding of the stress response and its longer-term impact on the body and the brain. During the Seven Years War a physician from Austria, one Joseph Auenbrugger, observed and documented symptoms in some troops such as excessive physical exhaustion, anger, and irritability , and depressed mood. He termed the condition nostalgia after the soldiers being so homesick, and so far distant from that which they knew, that their personality and the core of who they were was significantly changed. In his 1761 book Inventum Novem he wrote:
When young men who are still growing are forced to enter military service and thus lose all hope of returning safe and sound to their beloved homeland, they become sad, taciturn, listless, solitary, musing, full of sighs, and moans. Finally, these cease to pay attention and become indifferent to everything, which the maintenance of life requires of them. Neither medicaments, nor arguments, nor promises, nor threats of punishment are able to produce any improvement.2
The diagnosis of what is now accepted as Post Traumatic Stress Disorder has changed over the years as we have gained a better understanding of the stress response and its longer-term impact on the body and the brain.
New Hope For Ptsd Treatment
The latest trial results for MDMA-assisted therapy are inand they are eye-catching.
Existing treatments for posttraumatic stress disorder are few in number and, too often, ineffective. Although still classified as a Schedule I drug, methylenedioxymethamphetamine has improved symptoms PTSD in clinical trials.
In this Mental Health Minute, Tiago Reis Marques, MD, PhD, shares the results of a new phase 3 trial, in which the MDMA-assisted arm of the study outperformed the placebo by 35%. He revisits the history of MDMA and looks to the future, when this Schedule I drug may be approved as a legal treatment.
Dr Marques is a senior clinical fellow on the Faculty of Medicine at Imperial College London, an instructor at the Institute of Psychiatry in Kings College, and the CEO of Pasithea Therapeutics.
Would you prescribe a psychedelic like MDMA? Share comments with your colleagues by emailing . Comments may be shared online pending review and editing for style.
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Secondary Effects Of Interpersonal Trauma
The most interesting data yet on MDMA-assisted therapy.
The great challenge is the secondary effects of interpersonal trauma. Namely on your capacity to feel safe with people, to love yourself, to find yourself a worthwhile human being, to not be frightened about all kinds of different things, to be open, to be curious.
And that is not being measured in the main study that makes all the big press. But we did secondary analysis on self compassion, self regulation and alexithymia, understanding yourself.
To my mind, this is the most interesting data yet on MDMA-assisted therapy for PTSD. Ive done research for 50 years, and Ive never seen anything like it. It is stunning.
The data that we collected very much are in line with what we saw clinically in our subjects in our study. We only have a limited number of people. But every single subject that we saw had remarkable experiences of going very deeply inside.
People actually go into their trauma and they lie there and they suffer, as they go into it. But the natural defenses that keeps people from going there seem to dissolve in MDMA-assisted therapy.
So people have their experiences and say: «yeah, I was raped when I was three years old. And they go like «this poor kid, this poor child who I once was, that I had to go through it».
MDMA-assisted psychotherapy is expected to become an FDA-approved treatment within the next few years. Read more on maps.org.
The Search For Effective Therapies For Ptsd
The ideal PTSD treatmentsafe, effective, and fast-acting, with few side effectshas been elusive. And as with many mental-health issues, patients sometimes have trouble accepting or adhering to some of the options that are available. The Department of Defense and healthcare researchers have pursued a variety of solutions for years.
In the early 2010s, some military medical centers began offering patients with PTSD a procedure that had been used for decades to relieve pain. The procedure, called stellate ganglion block, or SGB, involves injecting a local anesthetic into the stellate ganglion. This group of nerve cells and nerves in the neck helps regulate the bodys fight or flight mechanism.
As more and more patients tried the stellate ganglion block, the reports seemed promising. But the medical community still needed evidence of its effectiveness. RTI in 2014 launched a randomized, controlled trial of SGB, and in fall 2019, we found that it is indeed effective.
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How Is Ptsd Conventionally Treated
Generally, PTSD is treated with therapy, medication, or a combination of the two. While this approach can be highly effective for some individuals, remission rates remain high at around 3040%.¹
Despite the high prevalence of PTSD , research into the most effective therapies remains surprisingly limited. The effects of treatment between individuals can be highly variable. There is often low compliance with medication or therapy, contributing to this variability.
Therapy options with the strongest evidence base include cognitive behavior therapy and eye movement desensitization and reprocessing . Conventional drugs administered for PTSD are antidepressants, mainly sertraline and paroxetine.
The stigma around PTSD remains high, leaving individuals misunderstood and seen as dangerous, incompetent, or responsible for their condition.
Stigma has been identified as contributing to increased helplessness and reduced functional recovery in some individuals with PTSD. As a result, there is a growing need to change the way PTSD is both understood and treated particularly for those who arent responding to traditional medicine.
Its Not Likely To Be A Magic Cure
Take note of the numbers described above. The patients who received SGB treatment saw significant improvement 34%. This is a welcome improvement for those patients. However, 34% is not 100% or even 50%. Results can vary from one person to another, as they do with any treatment some patients do see a very significant improvement in their symptoms, but many do not. SGB is not likely to revolutionize the treatment of PTSD.
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Placing Clinical Practice Guidelines In Context
Provision of high quality, effective care that reduces symptoms and helps the patient return to higher levels of functioning is a shared goal for patients and their families, practitioners, policy makers, and administrators. But knowing which information to trust and prioritize is not easy, and synthesizing available research and determining preferable care options can be daunting. Clinical practice guidelines are an essential tool to guide clinical decision-making and make it easier for patients to get the care they need. Clinical practice guidelines are intended to be a centralbut clearly not the onlydeterminant of treatment choice. Other factors include patients preferences and histories, providers expertise and judgment, nonspecific factors in psychotherapy, and patients individual differences.
There Is Evidence Sgb Works
There are many popular treatments for PTSD. However, only some are backed by evidence from rigorous scientific studies like the one described above. You can learn about other such evidence-based treatments for PTSD on our PTSD treatment options page these treatments include prolonged exposure therapy and cognitive processing therapy , cognitive therapy, and cognitive-behavioral therapy . In fact, at this time, these four treatments have much more evidence behind them than SGB. For that reason, they are first-line treatments for those suffering from PTSD.
For those who have tried one or more first-line treatments and not achieved sufficient relief from PTSD, there are several available alternative treatments available. These include narrative exposure therapy , medications, and eye movement desensitization retraining . These are also supported by some research evidence, but not to the extent that PE, CPT and CBT are.
So where does SGB fit in this picture? For now, it appears to be a promising option for those who have tried at least two other treatment options but who continue to have significant PTSD symptoms.
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How Does Sgb For Ptsd Work
We cannot conclusively prove the exact mechanism that explains the positive effects of stellate ganglion block for PTSD. However, we certainly have some understanding of it. It is suspected that the activity of the sympathetic nervous system is slowed by the effects of the injection.
The sympathetic nervous system is what helps us respond to a threat. It helps elevate our heart rate and the pace of our breathing, and it helps us respond to threatening situations. It is responsible for what is known as the fight-or-flight response. In many people with PTSD, the sympathetic nervous system is overactive. This likely contributes to some PTSD sufferers feeling constantly on guard and prone to exaggerated responses. Such responses can be triggered by loud noises or other situations that may potentially turn dangerous like being in a crowd or somewhere reminiscent of the original traumatic event.
References And Further Reading
Carroll A. Can psychedelics be therapy? Allow research to find out. The New York Times. July 17, 2017.
Hudenko W. The relationship between PTSD and suicide. PTSD: National Center for PTSD. U.S. Department of Veterans Affairs. March 28, 2017.
Ross S Schmidt BL. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial. J Psychopharmacol. 2016. DOI .
Sessa B. Turn on and tune in to evidence-based psychedelic research. Lancet Psychiatry. 2015. DOI.
Tupper KW Johnson MW. Psychedelic medicine: A re-emerging therapeutic paradigm. CMAJ. 2015. DOI .
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Research From Georgia Tech And Emory University Leads To Fda Breakthrough Designation For New Ptsd Treatment
Omer Inan is the Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering and associate professor in the School of Electrical and Computer Engineering.
PTSD, or post-traumatic stress disorder, doesnt discriminate. It affects about 15 million adults in the U.S. each year. And more than half of the people with PTSD are left with a severely impaired quality of life, including disturbing thoughts, feelings, or nightmares related to their traumatic experience, as well as fear, sadness, and anger, or detachment from others. Its a disabling psychiatric disorder with few treatment options.
A pilot study from Georgia Tech researcher Omer Inan and Emory University psychiatrist Douglas Bremner opens the door to a hopeful new therapeutic alternative for people suffering from PTSD. Their work, published in Decembers Journal of Affective Disorders Reports, supports the recent Breakthrough Device designation from the FDA for a new treatment for PTSD. Its called non-invasive vagus nerve stimulation, or nVNS.
The concept was to see if this commercially available stimulation device could be used to reduce the physiological response to the stress triggers that PTSD patients encounter, said Inan, the Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering and associate professor in the School of Electrical and Computer Engineering. And our results were very encouraging they suggest that this is a practical, safe, and novel treatment.
FDA Fastrack
Study Finds Potential New Treatment For Preventing Ptsd
by Centre for Addiction and Mental Health
Research led by the Centre for Addiction and Mental Health published in the Journal of Clinical Investigation points to a groundbreaking discovery about a new potential treatment and prevention for post-traumatic stress disorder .
The research team, led by Dr. Fang Liu, Senior Scientist and Head of Molecular Neuroscience in CAMHs Campbell Family Mental Health Research Institute, and Professor and Co-director of Division of Neuroscience and Clinical Translation, Department of Psychiatry at the University of Toronto, recently identified a protein complex that is elevated in PTSD patients. The researchers also developed a peptide to target and disrupt the protein complex. They found that the peptide prevented recall or encoding of fear memories in early tests. This suggests that the peptide could treat PTSD symptoms or prevent them entirely.
PTSD occurs in some people after experiencing or witnessing traumatic events, such as sexual assault or military combat. Patients can suffer from debilitating flashbacks, nightmares and anxiety which can severely impact quality of life. There are currently no laboratory diagnostic tests for PTSD, and existing treatments have limited efficacy. According to a recent study published in the British Journal of Psychiatry, Canada has the highest prevalence of PTSD among 24 examined countries, and 9.2 per cent of Canadians will develop PTSD in their lifetimes.
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Ptsd Treatment: How To Treat Ptsd In 2023
Trauma recovery is often a slow and challenging process that calls for a lot of work from the survivor and those administering PTSD treatment. Its worth noting that there are diverse treatment options for post-traumatic stress disorder . What works for one survivor might not work for another. Various factors, such as the severity of the trauma and the survivors responses to the trauma, can result in varying levels of effectiveness in PTSD treatment. In this article, well elaborate on what PTSD is and what the various PTSD treatments are.
Managing The Profound Manifestations
Where can I get this damn drug?
Bessel van der Kolk: Im really glad with what you said because its also my experience. What Im worried about is that once people hear you and me talk, theyll go like, oh, my God, Ive got to do this!
I wonder how we can to keep these things contained. I think were lucky to be here at the beginning of this revelation. Basically, when things are still well organized and nobodys trying to make money off it, or exploit it yet.
So Im worried what will happen to this, because the last time people had the same experience back in the 60s people got too enthusiastic about it. So things went out of control. And as I hear you speak, I go like: where can I get this damn drug?
So the question is, how are people capable of managing the profound manifestations that come from this work?
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What To Look For In A Ptsd And Addiction Treatment Program
If you are looking for a treatment program that offers treatment options for PTSD and addiction, we recommend keeping an eye out for several important factors. First of all, look for a treatment center that offers:
- Individualized treatment options that focus on your unique, personal needs and clinical requirements.
- A staff composed of a team of licensed and highly experienced professionals both therapeutic professionals with personal backgrounds in trauma and medical professionals.
- At least 30 days of inpatient treatment. In most cases, people with dual diagnosis disorders require at least 90 days of intensive inpatient treatment. The duration of your personal treatment program will depend heavily on what is best for you. There are a
- A range of luxury accommodations, ranging from private or semi-private bedrooms to daily meals prepared by a professionally trained chef.
The things you should look for in a PTSD treatment program also depend on several personal factors, including:
- Whether or not you have sought treatment for PTSD in the past.
- How many co-occurring disorders you are currently suffering from.
- If you have pre-existing obligations that might prevent you from entering into residential rehab.
- Other potential restrictions, like what kind of health insurance policy you currently have and how far you are willing to travel for rehab.
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Why It’s Important To Seek Treatment Right Away
If you or someone you know suffers from PTSD or severe anxiety, it’s important to get medical help as early as possible. Apart from the toll this condition takes on a person’s mental health, it can also cause serious physical harm to the brain. WebMD states that PTSD can cause the hippocampus to get smaller over time.
Early treatment improves your quality of life in both the short and long term, so don’t put off getting the help you need! Schedule an appointment with Aspen Orthopedic Pain and Spine today and take back control of your life.
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