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OfflineAlan RockefellerM
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When Will Medicinal ‘Magic Mushrooms’ Be Legalized? * 2
    #20212408 - 07/01/14 08:06 PM (9 years, 8 months ago)

http://themindunleashed.org/2014/07/will-medicinal-magic-mushrooms-legalized.html


Many people have now seen media stories about the renewed research interest in psychedelics as medicines, often called a “renaissance” in psychedelic research, over perhaps the past five years or so. Although many psychedelic substances have been used safely as medicines in indigenous cultures for millennia, we are now seeing renewed interest in these substances in Western cultures. As a co-founder of the Heffter Research Institute  I have watched with an increasing sense of both amazement and gratitude — that we have been able to accomplish so much in such a relatively short time. We are on the path to make psilocybin into a prescription medicine! The Heffter Institute has been a key driver of this “renaissance,” utilizing most of the donations we receive directly to support clinical research.

Heffter initially provided major funding for a small study of psilocybin treatment for obsessive-compulsive disorder (OCD) patients, at the University of Arizona. That study provided mixed but encouraging results that have yet to be pursued due to funding limitations.

Our first truly successful study was treatment of 12 terminal cancer patients who suffered from anxiety and depression. They were treated with a program of therapy that included psilocybin, the active component in so-called magic mushrooms. Participants showed a significant reduction in anxiety at one and three months after treatment, with no significant adverse events. That study, led by Dr. Charles Grob at the UCLA Harbor Medical Center, was published in 2011 in Archives of General Psychiatry, widely recognized as perhaps the top psychiatry journal in the world.

Subsequently, two additional studies were begun using psilocybin to treat anxiety and depression in cancer patients, one at Johns Hopkins University led by Dr. Roland Griffiths, and the other at New York University (NYU) directed by Dr. Stephen Ross. The patients in both studies have almost completed their treatments, then the studies will start the follow-up and data analysis stage. Preliminary analysis points again to significantly decreased anxiety and depression.

Research shows psilocybin attenuates anxiety, slows down activity in areas over active in people with depression, can induce mystical, life-changing experiences and enhance mood and personal relationships. 


In addition, the Heffter Institute recently sponsored a study of psilocybin-assisted therapy in a pilot study of 10 volunteers with alcohol dependence. The principal investigator for this study was Dr. Michael Bogenschutz, at the University of New Mexico (UNM). Drinking decreased significantly beginning in the second month of treatment, after psilocybin was administered, and improvement remained significant for an additional six months of follow-up. There were strong correlations between the intensity of the experience in the first psilocybin session and clinical improvement following the session. Based on the positive findings from this pilot study, we are now implementing a larger randomized trial at UNM and NYU.

We also recently supported a pilot study by Dr. Matthew Johnson at Johns Hopkins, administering psilocybin within a 15-week smoking cessation treatment. Participants were 15 healthy smokers with a mean of six previous lifetime quit attempts who were smoking an average of 19 cigarettes per day for 31 years. Measures of smoking behavior showed that 12 of the 15 participants (80%) were no longer smoking at six-month follow-up. This smoking cessation rate substantially exceeds rates commonly reported for other types of therapies (typically less than 35%). These findings suggest that psilocybin may be a useful and potentially efficacious adjunct to current smoking cessation treatment approaches, and warrant a follow-up clinical trial. Results also illustrate a framework for research on the efficacy and mechanisms of psychedelic-facilitated addiction treatment.

When people hear that we are sponsoring medical research with psilocybin, they often ask, “How long before doctors will be able to prescribe it?” The process to get there is both expensive and time-consuming. To get a drug to market, that is, to make it into a medicine, there are three clinical phases that must be completed. Phase 1 involves giving a new drug to humans to determine whether it can be tolerated, if it is safe, and what doses are acceptable. For psilocybin, there are extensive data with respect to doses and safety of psilocybin, particularly as it has been used in the form of psychedelic mushrooms since prehistoric times. Further, none of the participants in our treatment studies has required medical or psychiatric intervention.

After passing Phase 1, the drug is then moved to Phase 2, where it is administered to patients suffering from the medical condition one wishes to treat. In our case, it is cancer patients who have severe anxiety and depression as a result of their cancer diagnosis, including those who are near the end of life. Although Phase 1 can be relatively small, Phase 2 studies must be large enough to demonstrate a statistically significant improvement in the condition being treated; in this case it is anxiety and depression.

Once Phase 2 studies have demonstrated that the medicine reduces the patients’ symptoms, called efficacy, a Phase 3 trial must be completed. Phase 3 studies are much larger, but use the same medication and essentially the same treatment paradigm that was used in Phase 2. Also, Phase 3 studies are typically conducted at several different clinical sites to show that the improvement observed in the Phase 2 studies can be repeated by other clinical scientists. When the Phase 3 studies are completed, if significant safety and efficacy can be shown, the FDA can then approve the medicine as safe and effective for the indicated condition.

One important implication of such a finding by the FDA concerns drugs that are controlled substances. Psilocybin is a controlled substance and is placed in the most restrictive category of drugs, Schedule I. Schedule I drugs can only be used in research; they cannot be prescribed as medicines. Drugs are placed into Schedule I if they meet three criteria, if they have: 1) A high potential for abuse; 2) No recognized medical use and; 3) No safety when used under medical supervision. All three of these criteria must be met when placing a drug into Schedule I.

To make psilocybin into a prescription drug, these factors must be addressed. First, the safety of psilocybin is being established not only by our studies, but also by studies in Switzerland and the U.K. The key point that needs to be addressed, however, is the issue of psilocybin having a recognized medical use. If our Phase 3 studies show efficacy in alleviating anxiety and depression in cancer patients, and the FDA recognizes that finding, we will have established a medical use for psilocybin. It then can no longer remain in Schedule I and will have to be placed into a lower schedule such as Schedule II or Schedule III. Although substances in Schedules II and III are still controlled, this rescheduling will allow psilocybin to be used by qualified physicians as a medical treatment for anxiety and depression.

How long will it be before psilocybin can reach the status of being a recognized medical treatment? Assuming that we can demonstrate efficacy in the Phase 3 studies, as it appears we have in the current Phase 2 studies, the timing largely depends on how quickly we can complete the Phase 3 studies. Our most efficient recruiting so far has been at NYU, where the study team has recently averaged 15 patients per year. We would plan to recruit patients across several clinical sites – optimistically up to five, and would expect that with average to good recruitment rates we might complete recruitment, study procedures, and data analysis in four to five years.

How much will the Phase 3 studies cost? As a not-for-profit institute, our costs have been lower than they might be if we were a for-profit pharmaceutical company. Even so, as an average, treatment is costing us approximately $25,000 per patient. That includes costs for clinical treatment rooms, medication, therapists, and many other ancillary costs required to carry out a clinical study. It would be reasonable to expect total costs for a Phase 3 trial of this nature to be on the order of $7.5-8 million.

Many people also ask, “Aren’t drug companies interested in psychedelic medicine?” The answer, unfortunately, is no. Psychedelic medicines have been around so long that they are no

longer patentable, and they work after one or sometimes two treatments. There is no money to be made with a non-patentable drug that is given only once or twice in a lifetime. Typical drug treatments are given daily, sometimes two or more times a day, and for many medical conditions the treatment can last years, or even a lifetime.

The next question they often ask is, “Isn’t there any government funding for this work?” Again, sadly, the answer has been no, although we hope that may change as our studies progress. We must still overcome the echoes of the past, where psychedelics were considered dangerous and unpredictable. Fortunately, more enlightened voices are beginning to prevail and the landscape is slowly changing. If you would like to become a part of this powerful and emerging medical science, go to our web site www.heffter.org and make a donation to support our work.

This article originally appeared on reset.me, and is reposted here with permission as a contribution from Emmy Award winning investigative journalist Amber Lyon.

Credits: Article Written By David E. Nichols, PhD

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OfflineLittleDaddy
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller]
    #20212706 - 07/01/14 08:56 PM (9 years, 8 months ago)

interesting read - came across it 2 days ago.

i didn't know 5 years ago was the beginning of this "renaissance", but it is definitely gaining more and more traction. people I have talked to seem more open to the idea of psychedelics, especially after a little more information.

Ayahuasca is becoming a relatively popular topic of conversation and I hear from the most unexpected people.

That article about part of the Islamic community accepting entheogens is pretty big. Times are changing. Fast. Seems like we're still a ways a way though!


--------------------
The hotter the battle, the sweeter Jah victory.
Put the heathen's back upon the wall.

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OfflineViridis420
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: LittleDaddy]
    #20212796 - 07/01/14 09:15 PM (9 years, 8 months ago)

Very interesting, as with medical marijuana gaining momentum and the youth of today becoming more acceptable I feel it's only a matter of time before Psilocybin mushrooms are used like medical marijuana. Plants and Fungus hold the keys to a better life.

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InvisibleShaolinMasterKilla
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Viridis420]
    #20213040 - 07/01/14 10:05 PM (9 years, 8 months ago)

Quote:

Viridis420 said:
Very interesting, as with medical marijuana gaining momentum and the youth of today becoming more acceptable I feel it's only a matter of time before Psilocybin mushrooms are used like medical marijuana. Plants and Fungus hold the keys to a better life.




I was just about to say the same thing. The next generation will see thru all the bullshit and lies. I wish the scumbags that are against marijuana, shroom, lsd and ecstasy legalization would die already.

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OfflineLittleDaddy
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: ShaolinMasterKilla]
    #20213056 - 07/01/14 10:09 PM (9 years, 8 months ago)

Quote:

I wish the scumbags that are against marijuana, shroom, lsd and ecstasy legalization would die already.




This just perpetuates the baseless schisms that cause prohibitions and pointless violence.


--------------------
The hotter the battle, the sweeter Jah victory.
Put the heathen's back upon the wall.

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InvisibleShaolinMasterKilla
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: LittleDaddy]
    #20213246 - 07/01/14 10:54 PM (9 years, 8 months ago)

Quote:

LittleDaddy said:
Quote:

I wish the scumbags that are against marijuana, shroom, lsd and ecstasy legalization would die already.




This just perpetuates the baseless schisms that cause prohibitions and pointless violence.




<SNIP>

No flaming

Edited by Mostly_Harmless (07/02/14 01:45 AM)

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InvisibleStygianKnight
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: ShaolinMasterKilla]
    #20213340 - 07/01/14 11:17 PM (9 years, 8 months ago)

It's not the people that need to die, it's their lies.
If they die but their lies continue, nothing will change.

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OfflineLittleDaddy
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: StygianKnight]
    #20213444 - 07/01/14 11:58 PM (9 years, 8 months ago)

Quote:

StygianKnight said:
It's not the people that need to die, it's their lies.
If they die but their lies continue, nothing will change.




let the lies be poisoned with reality and science, not pride and ignorance, shaolinmasterkilla.


--------------------
The hotter the battle, the sweeter Jah victory.
Put the heathen's back upon the wall.

Edited by LittleDaddy (07/02/14 12:01 AM)

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OfflineAlan RockefellerM
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller]
    #20213586 - 07/02/14 12:38 AM (9 years, 8 months ago)

Quote:

Alan Rockefeller said:
This article originally appeared on reset.me, and is reposted here with permission as a contribution from Emmy Award winning investigative journalist Amber Lyon.






I emailed Amber Lyon and gave her some Psilocybe pictures that I took in Mexico, and one of them is now on the front page of her website.

http://reset.me

If you aren't familiar with Amber's work, it is pretty awesome: 
  There aren't many people in the world that can speak up for psychedelics as eloquently.

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Offlineresonant111
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller]
    #20214640 - 07/02/14 10:44 AM (9 years, 8 months ago)

i saw some abc news article about psilocybin's potential to treat people with post traumatic stress and even just depression in general. never thought i'd see that kind of research presented positively in mainstream news...


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Offlinewocka
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: resonant111]
    #20214733 - 07/02/14 11:22 AM (9 years, 8 months ago)

since my mom has really bad bipolar depression whatever you want to call it, I know I have some form of this gift. And I always knew shrooms were helping me and my mind.

Its insane that some other human animal wants to tell me I cannot dose shrooms and that I need to take artificial pills. No, Mother natures got your back.


the medicine helps with the everyday struggle of the lost youth, I can relate to this post

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InvisibleThayendanegea
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller]
    #20215051 - 07/02/14 12:55 PM (9 years, 8 months ago)

Alan:...Thanks for this very descriptive and informative piece. I wasn't aware of the different phases of research that must take place in order to become legal medicine.

Thanks also for the links to the various university studies...I am familiar with the Hopkins study...even have a friend that was asked to participate...he declined. Amber Lyon sounds like she believes in what she is doing and can't be bought. These are not just some old liberal hippies trying to get their ha ha's....this is real.

I do believe you have mycelium in your veins...Thanks again.


--------------------
Look Deep Into Nature,and Then You Will Understand Everything Better.

Albert Einstein

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Invisiblebadchad
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller] * 1
    #20215087 - 07/02/14 01:08 PM (9 years, 8 months ago)

Unfortunately, while its a possibility, I think the author has underestimated many of the FDA requirements for approval.  When you examine typical sample sizes for a combined Phase 2/3 program, you will see that the patients number in the thousands.

In the last 7-10 years, there have been maybe, 100+ subjects in completed studies.  These studies used varied subject populations, so they won't be considered as evidence of Phase 3 efficacy.

As is often the case, he's also completely missed the mark on the "non-patentable" issue.  It's irrelevant due to the exclusivity conferred upon approval. 

It can be done, but this article is perhaps, a bit overly optimistic.


--------------------
...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436

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OfflineAlan RockefellerM
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: badchad]
    #20215669 - 07/02/14 04:18 PM (9 years, 8 months ago)

Quote:

badchad said:
Unfortunately, while its a possibility, I think the author has underestimated many of the FDA requirements for approval.  When you examine typical sample sizes for a combined Phase 2/3 program, you will see that the patients number in the thousands.

In the last 7-10 years, there have been maybe, 100+ subjects in completed studies.  These studies used varied subject populations, so they won't be considered as evidence of Phase 3 efficacy.

As is often the case, he's also completely missed the mark on the "non-patentable" issue.  It's irrelevant due to the exclusivity conferred upon approval. 

It can be done, but this article is perhaps, a bit overly optimistic.





I conveyed your comments to David Nichols, hope you don't mind.  He said:

Alan:

We are working with a very experienced consultancy group on this research. The number needed for phase 3 studies depends on the robustness of the response, which is very high in our studies. Studies that number in the thousands may be typical for something like antidepressant trials, but not in our case.  Our populations are terminal cancer patients; they are not varied.  I also do a lot of work with pharma on patents and intellectual property, so I understand patentability issues.  I stand by my essay.

Dave

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Offlinecircastes
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller]
    #20216919 - 07/02/14 09:43 PM (9 years, 8 months ago)

I can't actually believe mushrooms are under wraps like they are. Everyone should be taking them, that's the kind of significance they hold. Yet they're illegal, unresearched and generally shunned as dangerous or outright weird.

They are a direct route to mystical consciousness, they are the Eden from which we fell, they are the first five years of childhood.

I also believe they may physically heal the body, not just mentally. I think it may have set something off in me, to repair some physiological issues, that continues to drive itself now that it's activated. Research will surely come up with this one day.


--------------------
My solitude...
My shield...
My armour...

TESTED
WITH
FULL
FORCE

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InvisibleJimmy Sage
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller]
    #20216998 - 07/02/14 10:03 PM (9 years, 8 months ago)

This makes me very excited.

Thank you for sharing all this information in this thread

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Invisible5cruffyMuff
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Jimmy Sage]
    #20217052 - 07/02/14 10:14 PM (9 years, 8 months ago)

You guys wanna know what before I ever took mushrooms I was a very self centered. Was a Dick to people, was not aware. The day I dosed myself 7 grams that all changed.
My addictions where gone the next day. It didn't change Me but it instilled an awareness that I never knew existed. Its like my brain went threw a rest.
mushrooms + meditation = bliss

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Invisiblebadchad
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Alan Rockefeller] * 1
    #20218371 - 07/03/14 07:22 AM (9 years, 8 months ago)

Quote:

Alan Rockefeller said:

I conveyed your comments to David Nichols, hope you don't mind.  He said:

Alan:

We are working with a very experienced consultancy group on this research. The number needed for phase 3 studies depends on the robustness of the response, which is very high in our studies. Studies that number in the thousands may be typical for something like antidepressant trials, but not in our case.  Our populations are terminal cancer patients; they are not varied.  I also do a lot of work with pharma on patents and intellectual property, so I understand patentability issues.  I stand by my essay.

Dave




He's correct, but his comments are pure speculation.  The language of the Food Drug and Cosmetic states (generally) that "evidence consisting of adequate and well-controlled investigations" are needed for drug approval.  Like most legal and regulatory documents, companies and individuals have challenged exactly what that means.  in the FDA's own documents  they describe some of the prior court cases where the issue has been discussed.  In sum, the sample size will be an arbitrary decision, but assuming it'll be small due to robustness is just that, an enormous assumption.

Regarding the patentability issue, drug patents last 20 years.  Often, it takes more time than that to get a drug to market.  This is precisely why "exclusivity" periods exist.    This is done all the time in the industry, old drugs (long off patent) are approved for new indications to get an exclusivity period.  Again, Nichols is right that pharma won't develop psilocybin since it won't make any money.  However, the lack of money is because it'll only be used 1-2x/year, not necessarily because of patents.


--------------------
...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436

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OfflineAbsent Minded
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: badchad]
    #20218439 - 07/03/14 07:53 AM (9 years, 8 months ago)

Quote:

ShaolinMasterKilla said:
Quote:

Viridis420 said:
Very interesting, as with medical marijuana gaining momentum and the youth of today becoming more acceptable I feel it's only a matter of time before Psilocybin mushrooms are used like medical marijuana. Plants and Fungus hold the keys to a better life.




I was just about to say the same thing. The next generation will see thru all the bullshit and lies. I wish the scumbags that are against marijuana, shroom, lsd and ecstasy legalization would die already.



People been sayin that shit since the '60's. ranted, more and more people DO see through the bullshit every single day, month, year, decade, generation. Problem is, there will ALWAYS be those afraid of breaking the status quo and anything that isn't over proof rum and cigarettes. Plus, the crusty bastards in charge of amending/creating our laws are usually of this  breed.
90% of the population realizing the laws are blatantly facetious still might not matter one bit - take a look at the state of legalization now. Countless people in mostly every state endorse some form of marijuana decrim and/oor outright legalization. Do the lawmakers? Usually not. NJ has had decrim voted on at least twice, the majority of the pop. wants it, but Mr. Christie doesn't seem to like the green, so it still remains illegal, and people are still getting arrested daily and wasting thousands of dollars plus heartache on court fees, lawyer fees, etc.


--------------------


Beats
More Beats

sheekle: fuck peace love and unity
sheekle: death despair and misery
sheekle: is where it's at

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Invisibleledgrower
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Re: When Will Medicinal ‘Magic Mushrooms’ Be Legalized? [Re: Absent Minded]
    #20222195 - 07/04/14 02:05 AM (9 years, 8 months ago)

Hard topic to talk on esp in this point in time where we are still arguing for marijuana facts to be the norm > lies to be the norm...


They may see very minor doses in pill form which I believe I read about for cluster headaches.

For PTSD I could see them having some effect.

I think legalization would come from these just going straight into pharmaceuticals...

Wouldn't be as free as just eating mushrooms to trip... More like take a pill with small dosages (which probably wouldn't make you trip at those dosages depending on what was being treated, ptsd and things like that would obviously have a higher dosage than a cluster headache for example).

There is a possibility of them getting legalized in the far future maybe (maybe even more nearer future). That would probably just be releasing the criminalization/demonization of the fungi though not making them legal because of medical use.


However unlike marijuana these should not be driven on.... (Although the tiny dosage for cluster headaches would probably be less impairing than a xanax). So dosage plays a role here. If the dose was enough to actually trip I'd say that's too much to drive (It can be done, but shouldn't, like alcohol and driving).


--------------------
If you are interested in 600 watt leds with 10watts per bulb $115 shipped pm me. 2x for $220.

Brand new from factory; mostly red/flowering spectrum lights.

Edited by ledgrower (07/04/14 02:11 AM)

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