A friend just sent me, thought it might be of interest. I didnt read the study yet but it shows how important it is to be careful with study design when trying to legitimize the use of these substances through official investigations.

http://scientopia.org/bl...-garbage-in-garbage-out/

Very interesting article. I can see how it would be a challenge to design a double-blind study. Easy to imagine how a person could clearly tell the difference between a placebo and 125mg of MDMA. And trying to erase that effect with a low "active placebo" dose... That could also be seen as a low therapeutic dose. Maybe a double blind study isn't really feasible, and that's just the wrong way to go about it.

It's too bad the stigma surrounding Ecstasy has made it difficult to properly evaluate its therapeutic effects- PTSD, depression, couples counseling, etc. With enough doctors administering these types of sessions, you'd eventually have a much broader base of data to work from.

kinda weird to critisize the double blind part based on the inevitable fact that people are gunna know that they got MDMA once it kicked in. What kind of moron does not understand that? That whole point just sounded stupid to make.

What's the point is giving people too low of a dose so that they dont know if they got anything? How is that useful for a study like this?

I just did a presentation in my critical thinking class that was an attempt to design a good test. I used a hypothetical situation, wich I had heard of previously, regarding a similar test done prior to the legislation underground of LSD, done in the US in the 1950s. In the test I based mine on, profeesionals who were experiencing difficulty with some professional problem, were given LSD to study the efficacy of "novelty" as termed by T. McKenna in problem solving.
below is the text of the presentation:

"Test= tests the " novelty" effect of LSD-25 on problem solving abilities in professional situations.

Theory=LSD-25 has an observed effect, termed novelty, that enables people under it's influence to receive novel insight into problem solving.

Hypothesis = professionals who present with a problem in their professional capacity, will receive novel insight into a solution while under the influence of LSD

Initial conditions =
1. Participants chosen from responders to a online request, on psychedelic research websites, like nexus.me (LITTLE PLUG TRAV, HA!)and maps.org. Number determined by response, 12-20 individuals tested.
2. Responses screened by panel for viability, level and nature of problem. (operationalize level of difficulty, to determine level of success in problem solving.)
2. Screened by psychologists for mental disorders.
3. Screened for addictions
4. Physical
5. Participants must be experienced with psychedelics.
6. In hotel room, with nurse present, doctor on call.
7. Physical prior to dose, and given blood pressure tests at the hour intervals.
6. Doses given in three levels, at ranges determined from prior tests, to provide 1,2, and 3 level trips according to Shulgin scale, at threes times, over course of threes months. ( ** note** this was determined to not be an effective test, as some participants may have solved ttheir problem in the first session, may work on it outside study, etc. It was decided to do three seperate dose level studies, at 1,2, and 3 on the S.Scale, to dtermine whether higher or lower doses provided more or less 'novelty' to increase data from a single test**) Do three separate dose level studies, with individuals being measured on their response for novelty at different levels (1,2,3,) according to Shulgin scale. (provide visual, from Erowid)
7. Questionaire given prior to and after each trip.
8. Guide, or sitter, trips with.
8. Provided all materials necessary for their work.
9. Participant provides music list.
9. Operationalize novelty.
OTHER IC POSSIBLE CONDITIONS
1. biometrics
2.


Auxiliary Assumptions=
1. divine inspiration (kind of expected result) other aspect of psychedelic. How to separate?
2. how could you separate another influence causing insight, if under influence? A.As hard to measure.
3. ?
4. ?
5. ?
"
This is just an assignment, but in my presentation, the issue of a blind test was brought up, I did not do a blind study exactly for the reasons that the above posters mentioned. Plus this test did not study the relativity between non-dosed people and dosed, so it is irrelevant.
There are efficacious test techniques to use when studying the effects of any pharmacologioal action. The biggest issue I ve seen and is brought up in almsot every discussion I have regarding psychedelic research, and one Im prone to fall into, is bias. I so want to find a effective treatment, so much want to have the results be positive, that it can scew my data.
Im not a scientist BTW, dont tear me up too bad, I actually did get an A+, applause that bwas more than polite, and opened a couple eyes. It was funner than hell.

Maybe the double-blind study should be done with MDMA and, say, an MAOI or painkiller... Something that would have no emotional therapeutic effects but that a subject might confuse as MDMA. Or maybe it is harder to tell that you are on MDMA if you are sensory deprived. You could do the same study, but with subjects blindfolded and deaf to everything but the therapist's voice. That might make it a bit harder to identify the sensual effects that are easily identifiable as being caused by MDMA.

Interesting critique, but this is how often CTIMPs (Controlled trials of an investigational medicinal product) go. This is because the ethics of such studies dictate that the well-being of the participants in the study is above all (obviously). The blogger criticizes from teh point of pure research, which is fair, but I do not think he has never been involved in the conduction of a CTIMP. CTIPMs are a whole lotta different animal.

In response to critique:



The blog authors writes that the study was unbalanced from the very beginning (12 treated vs 8 placebo) and he says the this unnecessarily complicates the study...but how? I do not see any extra complications anywhere. There really is no need to have balanced subject numbers. Most human studies will tend to be unbalanced one way or another. Adding to that, due to ethic standards, participants are free to withdraw consent and leave the study at any point - which also happens frequently in CTIMPs. So what if they had a balanced study in the very beginning but then subjects withdrew? The study would be bogus? Of course not.





Actually this was one of the best critiques to make about the study - their placebo was really bunk (it was a lactose pill) and obviously a test subject could tell the difference within less than an hour.

A better placebo could have been used, i.e. one that elicits some kind of response (e.g. slight increase in heart rate) to make subjects feel that "something is happening"




Maybe, but how and why? This also comes back to ethics - if for a subject the MDMA+psychotherapy session is actually yielding and moving towards a positive outcome, then you, as a researcher and in accordance to the Protocol which is approved by the Ethics Committee may agree to redose if the subject ask for, and possibly benefits from it. After all, this is a not a pharmacological study in mice or rats. This is humans we're talking about.



Silly criticism - it all comes again back to ethics, where the well-being of the subject is of utmost importance and way above the scopes of the study. If sleep aid was deemed necessary by a medical doctor, then it should be administered to the subject. It is of course a deviation from the Protocol, but deviations are often allowed and also recorded appropriately. Let's say that you administer an research compound thought to treat a viral disease and your subject gets a serious adverse reaction and his blood pressure rises, then what? you won't treat him? Or treat him and withdraw him from the study? In the case of latter we'd be happy to have 2 subjects per drug trial!


Well, you have to start from somewhere, right? A psychiatrist or psychologist could possibly say that the neuropathology or causes-and-results between different PTSDs is similar, so the MDMA results could apply to others as well.