Whats Considered a Safe Amount of MDMA every month

[Jabberwocky]

The thread title poses the question .... What is considered a safe amount of mdma every month.

There is only one answer............ None, zero, nil.

That's not an accurate statement.

The FDA is holding trials for the use of MDMA as a treatment for PTSD.


Accordingly, there MUST be a safe dose.

MAPS Phase 2 study:

This pilot Phase 2 study is examining the safety and efficacy of MDMA-assisted psychotherapy in 24 veterans, firefighters, and police officers with service-related PTSD.

12 subjects will receive a full 125 mg dose followed by a 62.5 mg supplemental dose;
six subjects will receive an active dose of 75 mg followed by a supplemental 37.5 mg dose;
and six subjects will receive an active placebo dose of 30 mg followed by a supplemental 15 mg dose.

So it seems that 187.5 mg is considered a safe dose.

http://www.maps.org/us-veterans-ongoing

 

[Cotcha Yankinov]

I don't think we can conclude that they think 125mg + 62.5mg is a "safe" dosing regimen, but rather that they feel that dosing regimen has a good risk vs. benefit ratio for that indication.

No drug is 100% safe with zero side effects, so issues of safety have to be considered alongside the indication and efficacy.

Just because a drug has been approved at a certain dosage doesn't necessarily mean that's a "safe" dosage - an example would be a cancer drug that has been approved at 100mg with a 10% chance of death but a 50% chance of sending the cancer to remission at that dosage. Just because its approved at a dosage doesn't inherently mean its 100% free of risk/side effects.

You'll also notice that your quote says "This pilot Phase 2 study is examining the safety and efficacy of MDMA-assisted psychotherapy".

Mind you that I'm all for MDMA assisted psychotherapy and I think the risk to benefit ratio will be amazing, I just don't think there will be absolutely zero risk when it comes to giving people prone to severe panic attacks etc. MDMA as they recall their trauma or whatever, especially when a lot of the symptoms like derealization with various drugs (including cannabis) often occur after panic attacks.

 

[Jabberwocky]

I don't think we can conclude that they think 125mg + 62.5mg is a "safe" dosing regimen, but rather that they feel that dosing regimen has a good risk vs. benefit ratio for that indication.

No,

The dose would be considered the maximum safe dose.

 

[Cotcha Yankinov]

My main point was that a particular approved dose is never 100% safe, it's just a good dose in terms of risk to benefit ratio. So above 125mg + 62.5mg the risk to benefit ratio may start to change unfavorably or the risk to benefit ratio may be more volatile.

 

[Jabberwocky]

My main point was that a particular approved dose is never 100% safe, it's just a good dose in terms of risk to benefit ratio. So above 125mg + 62.5mg the risk to benefit ratio may start to change unfavorably or the risk to benefit ratio may be more volatile.

Breathing isn't 100% safe - stop being obtuse.

Are you actually saying that there are not "safe dosage" amounts for drugs?

I guess every pediatric doctor in the country doesn't communicate to parents the safe dosage of diphenhydramine to give children.


There are safe dosage guidelines for aspirin, paracetemol, hydrocodone, morphine, and fentanyl

and as soon as MDMA is approved for PTSD as a schedule 2 or 3 drug -- there will be safe dosage guidelines

based on the dosages used in trials

 

[Cotcha Yankinov]

I think there's been a misunderstanding. What I'm saying is that there are certainly "safe upper limits" where a medication begins to have a volatile risk to benefit ratio but it's not like a drug is 100% safe as long as you stay below that upper range. Some small percentage of kids will still get i.e. Reye's syndrome with aspirin.

What I was trying to get at earlier is that "pure" safety data is evaluated alongside efficacy and the indication to give us the complete picture that we should be looking at. But safety isn't even fully evaluated until phase IV because the rare side effects are usually missed, phase II just captures the common ones. And if the new FDA appointee has his way it sounds like we won't even have phase III trials anymore lol, although it sounds like there is very little chance of that actually happening