The use of MDMA combined with therapy shows that in 18 weeks, patients with complex PTSD can be cured and no longer have symptoms of PTSD or in any case see their symptoms extremely reduced !!!!
At first glance, when I saw the study, I said to myself "but what are they doing? Give drugs, ecstasy to people who often present an addiction in their comorbidity, but they are crazy ... ". Then I read the study and watched the video you will find below, of a testimonial from one of the participants. And I find that brilliant and logical. Using this drug, in a safe environment and with professional monitoring can help incredibly!
So this study is in phase 3. If it obtains the marketing authorization, a larger study will take place.
There remains the question of addiction and dependence. They do not yet have enough hindsight to see if the patients treated in this way will not be dependent in the long term ....
And there remains a thorny question ... In terms of justice, what credibility will a patient have who has followed this therapy? Will his word be heard or will it automatically be called into question? How reliable will his memories be in the eyes of the law?
But even if it means choosing, I tell myself that if I am offered to treat myself and that I will no longer have symptoms, daily suffering after a few weeks ... I think I would not hesitate for long ... there that this is implemented in France by competent people ...
Excerpts from the study:
"In summary, MDMA-assisted therapy induces rapid treatment efficacy, even in people with severe PTSD, and in those with associated comorbidities, including dissociative PTSD, depression, a history of PTSD-related disorders. alcohol and substance abuse and childhood trauma. Not only is MDMA-assisted therapy effective in people with severe PTSD, it may also improve patient safety. Compared to current first-line pharmacological and behavioral therapies, the MDMA-assisted therapy has the potential to radically transform the treatment of PTSD and should be rapidly evaluated for clinical use.
Participants received three doses of MDMA or placebo in a controlled clinical environment and in the presence of a trained team of therapists.
Primary and secondary outcome measures (CAPS-5 and SDS, respectively) were assessed by a centralized pool of blinded independent diagnostic assessors.
After screening procedures and drug reduction, participants attended a total of three preparatory sessions, three experimental sessions, nine integration sessions, and four parameter evaluations (T1–4) over 18 weeks, ending with a final end-of-study visit.
Clinically significant improvement (decrease of ≥ 10 points on CAPS-5), loss of diagnosis (specific diagnostic measure on CAPS-5) and remission (loss of diagnosis and total CAPS-5 score ≤ 11) were each followed. On the primary endpoint of the study (18 weeks after baseline), 28 of 42 (67%) of participants in the MDMA group no longer met diagnostic criteria for PTSD, compared with 12 of 37 (32%) of those in the MDMA group. placebo group after three sessions. In addition, 14 of 42 participants in the MDMA group (33%) and 2 of 37 participants in the placebo group (5%) met the criteria for remission after three sessions.
Three doses of MDMA administered in conjunction with manual therapy over an 18-week period resulted in significant and robust alleviation of symptoms of PTSD and functional impairment assessed using CAPS-5 and SDS, respectively. MDMA also significantly alleviated depressive symptoms assessed using BDI-II. It should be noted that MDMA did not increase the frequency of suicides during the study. "
How clinical trials work:
"The different phases of clinical trials
To assess as completely as possible a new drug, a new treatment or a new method of management, different types of clinical trials are successively carried out. Each type corresponds to what is called a phase.
Phase I trials. They are also called “early trials”. The purpose of the phase I trials is to evaluate the first administration to humans of a new drug. They are generally carried out with the participation of a small number of patients (usually 20 to 40). This type of test aims in particular to determine the maximum tolerated dose, that is to say the dose of drug beyond which the side effects become too great. They thus make it possible to determine the dose which will then be used in subsequent tests. Phase I trials also provide initial information on how the drug spreads through the body (called pharmacokinetics).
Phase II trials. This type of test is used to definitively determine the dose of the drug associated with the best efficacy and the best possible tolerance. They provide more precise information on the distribution of the drug in the body and the first efficacy data. Phase II trials are generally carried out with a limited number of patients (several dozen).
Phase III trials. These are clinical trials that make it possible to evaluate the effectiveness of a drug, treatment or method of management. They are always comparative, that is to say, they compare a new drug (or new treatment) to a drug (or treatment) whose effectiveness is already well established and which thus serves as a benchmark. These trials require the participation of a large number of patients (often several hundred or even several thousand). These are divided into several groups (at least two) and receive one of the drugs (or treatments) evaluated. At the end of the trial, it is thus possible to know whether the new drug (or treatment) is doing better, as well or worse than the reference drug (or treatment). It is mainly on the basis of phase III trials that drugs obtain (or not) a marketing authorization (MA) and are marketed.
Phase IV trials. This type of testing is carried out once a drug has obtained its Marketing Authorization and is on the market. Phase IV trials aim to evaluate the drug in "real life", that is to say among all patients who take it and not only on selected patients as in the phase I to III. These trials make it possible in particular to collect information on side effects by specifying the frequency of their occurrence and by identifying infrequent side effects that had not been observed until then. They are generally non-comparative and often include a large number of patients (several hundred to several thousand).
What is randomization?
Randomization is a procedure that mainly concerns phase III trials, which compare several drugs, treatments or management methods. It involves randomly assigning the drug or treatment that each of the patients participating in the trial will receive. The team in charge of the test carries out a draw for this carried out by a computer.
Randomization ensures an equitable distribution of trial treatments among participants, without human factors being considered. This is a procedure primarily to ensure the scientific rigor of the test results.
What is the blind?
The blind is that the treatment received by a patient included in a trial is not known to him. When neither the patient nor the investigating physician is aware of the treatment assigned, it is referred to as a double blind. This again is to ensure that no human factor is taken into account in the test results when the test is being compared. If both the patient and the doctor know which treatment is first receiving, it can influence how the treatment is evaluated. For example, the patient who is receiving the standard treatment and who would have preferred to receive the new treatment may have, in good faith, the feeling that he is having a lot of side effects. Likewise, the doctor may have a tendency, if his patient receives an investigational drug from a trial and believes a lot in it, to appreciate its effectiveness more positively and to minimize its side effects a little. The double blind thus makes it possible to preserve the objectivity of the results. It mainly concerns phase III trials. "
A testimonial video of a person who participated:
The results of phase 3 of this study which show quite impressive efficacy results!
An article on the phase II study :
Phase II :
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