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An important issue was how stable

April 28th, 2009

An important issue was how stable his life was at the time. If it seemed in chaos, I would be reluctant to include him. If he was in a transitional stage, he might decide to leave the area halfway through the study. If his ability to sustain relationships appeared tenuous, he might not be able to bear up in the face of the powerfully destabilizing effects of DMT. He might have problems trusting us in the hospital under the influence, or he might not be able to find enough support between sessions if his experienceswere especially upsetting.

If Alex were using drugs or alcohol, he’d need to limit or stop taking them. This was especially the case if they were ones like cocaine orpsychedelics, which might affect his responses to DMT.

Information about previous psychedelic drug use and experiences was crucial. The number of his experiences was not as important as their having been fully psychedelic. Because his high-dose DMT sessions probably would propel him further into psychedelic space than he had ever gone before, I wanted to be reasonably certain Alex was at least familiar with the terrain.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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For the sake of convenience

April 25th, 2009

For the sake of convenience, I will invent a hypothetical volunteer named Alex, a thirty-two-year-old married male who worked as a software programmer outside of Santa Fe. Since most of our research subjects weremen, I hope no one is put off by making our generic volunteer male.

Alex’s first step was to make a phone call to my office, which was fielded by the psychiatry department secretary and subsequently answered by a member of the research team. After a brief conversation regarding age, previous psychedelic experience, and medical and psychiatric health,Alex and I made an appointment to meet in my department office.

Before this meeting took place, I sent him a packet of files, including a copy of the informed consent document for his particular study, several popular articles about DMT, and a paper I wrote some years before about the pineal gland, DMT, and consciousness. Later, when the project waswell underway, I included papers describing the results of our own work.

This meeting took at least an hour. I needed to learn enough about Alex to decide whether to include him in the study. In a comparable manner, Alex needed to know I was someone he could trust to supervise his deeply psychedelic DMT experiences.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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Part III. Set, setting and DMT

April 22nd, 2009

Being a volunteer

1 obtained approval for the DMT research in late 1990 and soon, with Philip and Nils as my human guinea pigs, determined the best doses and manner of administering the drug. It now was time to begin recruiting volunteers. While I found many volunteers among my longtime friends, I needed to enlarge the pool of research subjects beyond personalacquaintances.

I was reluctant to advertise. Such an announcement might have resulted in a flood of calls, and I did not have the time to speak to everyone with a casual interest. A public call for research subjects also might findits way to the local media and would draw unwanted attention.

Upon considering recruiting UNM students, I remembered the trouble that Leary and his associates encountered at Harvard when they included undergraduates into their program. If I were to canvas the university for volunteers, they would need to be graduate students, rather than the younger and less mature undergraduates. I also wanted to include no more than one representative from any department. Leary’s research at Harvard had created cliques of drug-taking graduate students. These students developed an “us” versus “them” mentality that contributed to intense conflicts within departments between those participating in psychedelic research and those who were not. Such envious and competitive ill will at Harvard was a significant factor in the ultimate expulsion ofLeary’s group.

Several volunteers in this new group were social or professionalacquaintances. Two were academic colleagues in the psychiatry department, one was a friend of my former wife, and seven belonged to a social group to which I was introduced several years after the research began. The nearly three dozen remaining people found out about the study by word of mouth; they were friends of volunteers, received psychedelic newsletters describing the Albuquerque research, or just happened to be in a conversation during which the studies were discussed.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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In September I called Mr. W. at NIDA

April 19th, 2009

In September I called Mr. W. at NIDA. He had just returned from a meeting with Dr. C. They were discussing how to get Schedule I drugs to researchers.

“We want to help,” he said. “Call Ms. B. at the DEA and see if she can tell you how to get approval for Dr. Nichols to make a small batch for you. If the amount is too large, he’ll need to be a legally designated manufacturerand will never be able to afford the required security.”

I called Ms. B. “Can Dave Nichols make some human-grade DMT for my project?” She began, “Well, if Dr. Nichols is going to be a manufacturer, he needs to meet rather stringent security requirements. Is there a DEA office near his university? They could drop over and tell him what he needsto do. Then Dr. Nichols could decide if he’s able to meet their recommendations.”

I heard the edge start creeping into my voice. I was alarmed at how close I felt to losing it.

“I’ve looked everywhere for human-grade DMT: Sigma and another chemical supply house, the National Institute on Drug Abuse, the National Institute of Mental Health, former investigators, Dr. C. in North Carolina. Dave Nichols is willing to make some for me, incredibly cheap.

He needs your okay. I’ve got an outside grant, and the Research Center at the university is behind this project. I’m losing my mind. I’m pulling out my hair. My gums are bleeding. I’m getting on my wife’s nerves.” There was a pause. I heard what sounded like her pushing her chair away from the desk.
“Oh,” she said, sounding genuinely concerned. “Let me see here. . . Yes, there’s a ‘coincidental activities’ clause in the regulations. Dr. Nichols can make a small batch if you’re collaborating. This won’t require any additional security for his laboratory.”

I heard her pull a large book out from somewhere: “It’s acceptable for him to make i t . . .” and she started reading some text,’”. . . if and to the extent set forth . . .’”

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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May and June involved finding laboratories

April 16th, 2009

May and June involved finding laboratories to run the FDA-required tests on the DMT once it arrived. One test required the DMT to be sent out, and the first two laboratories I contacted refused to work with a ScheduleI drug. Finally a third company agreed to do the testing.

By July 1990, Dave had made the drug and was running all the tests on it that the FDA needed to determine its identity and purity. It wasnearly 100 percent pure.

In early July he sent five grams of DMT to my clinic by overnight courier. I kept it in my office that day and drove to the hospital pharmacyto deliver it before going home.

I called Dr. W. to tell him that the DMT had arrived and that it might take a few months to get all the tests performed and collect the results.

He said, “Get everything together, and send it to Ms. R. the chemist and Ms. P. Call them a week later. They’ll say they never saw your letter. Then call me in two weeks if you don’t hear anything after that. Some poor guy got his approval and waited a month before we found someone to typethe letter to him.”

The pharmacy prepared a solution of DMT dissolved in saltwater. This was the form in which I would give DMT to the volunteers. The pharmacist divided it into one hundred separate glass vials. The samples for the FDA’s tests would come from them. I had a few last-minute questions and called Ms. R. in September. We hadn’t talked for a few months. “I need to refresh my memory about your case,” she said. After a fewadditional phone calls, she provided the necessary information.

By late October all the tests were complete, and the DMT passed every one. I put together my package and sent it to the FDA by overnight mail. I started calling within a week. No one replied to the dozen messagesI left with the secretary. I phoned Dr. W.

“What’s the matter?” he asked. “You usually call when things aren’t going well.”
“May I begin the DMT study?”
“I’ll just toodle on over there and find out what I can.”
I called back in early November. The secretary told me their division had changed offices, but that they came by every half-hour to check for messages.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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In addition, I received a high score from NIDA

April 13th, 2009

In addition, I received a high score from NIDA for a grant application to actually run the DMT study, and it was likely to be funded. Two grants approved, but no drug! It was bizarre. Everyone wanted the study done,but no one knew how to get me the drug necessary to perform it.

By February the DEA had obtained enough information from the FDA to know that the protocol was sound enough for the FDA to approve “in principle.” The DEA agreed to give me the Schedule I permit. However,my contact there, Ms. L., called with some bad news.

“Diversion Control blocked the permit.” “Who’s Diversion Control?” I asked.
“I’ll try and get your request exempted. I’ll call you next week.” The next day, Ms. B. from the DEA, the woman who had broken the logjam, called to say that Dave was indeed a manufacturer and would need additional security requirements. I didn’t know what to say.

I told her, “I don’t know what to say.” “Here’s the name and phone number of the DEA agent in Indianapolis, near Purdue University. He’s responsible for that area. He’ll tell Dr. Nichols what he needs to do.” She called back that day. “I’m sorry. Dr. Nichols is making another drug, and we mixed up that one with your DMT request. My error. Youmay go ahead as you were planning.”

Dave called later that week, saying the lawyers at Purdue were advising him not to make the DMT because of liability issues. I called Mr. W. at NIDA and asked him if there were ever any malpractice claims resulting from studies using their Schedule I drugs.

He offered some encouraging news: “We’ve never been sued for providing marijuana, a Schedule I drug, for human research. Just make sure you’ve got an airtight informed consent document.”He called back that day and put the NIDA attorney on the phone.

The attorney said, “You’d be sued first, then your university, then maybe the FDA, and last and most remotely Dr. Nichols. All he’s doing is making it according to FDA regulations. He’s not deciding who gives what dose to whom—that’s your responsibility.” I told Dave this, and he replied, “I hope you know what you’re doing. This is a real leap of faith for me and our lawyers.”

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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She spoke too quickly

April 10th, 2009

She spoke too quickly for me to write down the information. Ms. B. finished: “Have Dr. Nichols write me. Here’s my address. He’ll need to amend his current permits, saying how much DMT he’ll make. I’ll check with our pharmacist to be certain it’s a reasonable amount.”"Okay,” I said. “That sounds great. I really appreciate your help.”

I called Dr. W. He confided that “off the record,” my project was pointing out a flaw in the drug laws: How do researchers study drugs of abuse? He then described exactly how to respond to the twenty requirements the FDA had written about in the four-page letter that had arrived from them several months earlier. These steps would provide the FDA the informationthey needed to determine if the DMT was “safe for human use.”

The UNM Department of Psychiatry agreed to pay Dave Nichols three hundred dollars for the DMT. However, they would not write the checkuntil the DEA issued the Schedule I permit.

The DEA would approve neither Dave’s request to make DMT nor my Schedule I permit to possess it until the FDA approved the protocol. The FDA couldn’t give me permission until I possessed the drug and tested it for safety. The DEA also required verification from the FDA that Davecould go ahead and make the drug.

Four months later, in January 1990, Dave finally received DEA approval to make the DMT. He ordered the precursors immediately and beganworking on it.

In the meantime, I had gotten laboratory-quality DMT from Sigma and put it into the special locked freezer in the narcotics vault in the hospital pharmacy. One hundred milligrams, a tenth of a gram, in a little vial. The Research Center began developing a method to measure DMT in human blood.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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On November 5,1990, Ms. M., my project officer

April 7th, 2009

On November 5,1990, Ms. M., my project officer, called at the end of the day. “Your hold has been removed.” “Is a verbal okay all I need?”

“Yes.” “The university won’t accept that. Would you fax a letter?” I asked.
“I’ll fax one tomorrow.”November in the mountains of New Mexico is cold and dry, windy and
harsh. I made many of these phone calls from my house in the Manzano
Mountains southeast of Albuquerque. I sometimes joked to friends that
my applications had to be approved because my view was nicer than
anyone’s in D.C.
My former wife’s weaving studio was in a separate building about
fifteen yards from the main house. Hanging up the phone after that last
conversation with Ms. M., I braced myself against the cold wind and slowly
walked along the crunchy gravel path to the outbuilding to share the news.
“They said I could start.” I lay down on the cold cement floor, staring
up at the ceiling. “That’s great, dear,” she replied, leaning down to ground l to kiss my cheek.

I called every day for the next ten days, asking for the fax. It arrived on November 15. At the bottom of the handwritten fax, Ms. M. wrote, “Havea Happy Thanksgiving!”

That day, the university laboratory called to tell me the DMT in the glass vials had decomposed by 30 percent; it was too weak to use. I called the laboratory technician. “How did you calculate the concentration?”
He answered, “By using the weight of free base DMT.” “It’s not free base. It’s a salt.”2 “Oh, I didn’t know that. Hmm, let’s see. That’s right. It’s the correct
concentration after all. Sorry about that.” Four days later, I gave Philip the first dose of DMT.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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I called Dave Nichols

April 4th, 2009

I called Dave Nichols. He quoted me a price of $300—just the cost of supplies.

While all these calls were taking place, I knew that funding from outside the University was crucial for the project to gain all the legitimacy it needed. Additional financial support also would free up my time to find humangrade DMT and help the Research Center pay for some of the work I requested. This, in turn, would increase the Research Center’s backing ofthe protocol.

In looking over some of the old DMT and schizophrenia research, it appeared that the Scottish Rite Foundation, a branch of the Freemasons, had funded some of it through their Schizophrenia Research program. I asked this program to send an application for funding. My DMT proposal already discussed the importance of understanding DMT’s effects in its possible role as an endogenous schizotoxin. Therefore, it took little workto modify the grant to emphasize these issues more clearly.

I wrote Dr. Freedman, telling him of my grant submission to the Scottish Rite Foundation. He replied that he was on their scientific review committee, and “maybe” they would fund a year’s support. Within a month, in September 1989, a notification of award arrived announcing a one-yeargrant for the project.

I again wrote Dr. Freedman, updating him on the search for human grade DMT. He scribbled a note on my letter and sent a copy of it to the Director of the National Institute on Drug Abuse, one of his former students. His telegraphic missive ended: “Strassman needs someone at NIDA responsive. Any suggestions??”

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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A few weeks later Mr. W. called back

April 1st, 2009

A few weeks later Mr. W. called back, saying Dr. C. could make DMT, but I would have to pay for it. Dr. C. agreed to calculate an estimate, but repeated that he would not put together the required drug file for FDA.”It’s too much work.”

This seemed minimally promising. When I asked Ms. R. at the FDA about putting together my own drug file on Dr. C.’s DMT, she said she’dget back to me.

“If Dr. C. made the DMT, could I really use it?” “I’ll check with the drug abuse staff here,” she answered. “Why wouldn’t I be able to?” She answered, “I don’t know. Maybe our director, Dr. H., will call 5? Dr. C.’s estimate of the cost was over $50,000. “Well,” I said, “thanks for looking into it.”Another door closed.

I called Ms. R.: “I’m not having much luck. What do you suggest?” “I’ll go to the Federal Archives Building and see if I can find the previous DMT researchers’ files.” In July 1989 Ms. R. found the files for these old studies. “The data in them are terrible,” she said. “There’s nothing—no animal data, no chemistry data. We closed it. They never responded to our requests for progressreports. It won’t help you.”

“How did you ever approve that study?” “I don’t know. I didn’t work here then.” She tried sounding hopeful. “I’ll send the information you need to set up your own drug file.” The information she sent was designed for a large drug company such as Lilly, Merck, or Pfizer. It had nothing to do with an individual investigator.

I called Ms. R. “I need help. Why aren’t you helping me?” “Our director’s name is Dr. H. Here’s his phone number. Insist on speaking with him.” I called Dr. H.’s office. Dr. H.’s secretary said, “You’ll need to speakto Dr. W.”

Before I could protest, he transferred the call to Dr. W. “This is Dr. W.!,” boomed the friendly but commanding voice on the other end of the line. “I’m the only physician on the drug abuse staff in this new division. I know what you’ve been going through. We’re here to help. Don’tdespair.”

“How can I get human-grade DMT?” I asked. “Find someone to make it for you.”

“How about Dave Nichols at Purdue?” He replied, “That’s possible.” “Could you and Dave talk with each other?” “Have Dr. Nichols write to the director, Dr. H. Here’s his address. The name of the staff working on your request is Ms. M. Call her in two weeks.”I felt something shift with that phone conversation.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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