Psychedelic Drugs : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Promising Potential

Early research suggested medical promise for psychedelic drugs. According to a 1992 report by Richard Yensen, Ph.D., and Donna Dryer, M.D., director and medical director at the Orenda Institute, a 1960s' study of 135 alcoholics found that six months after treatment with LSD, 53 percent of a high-dose group reported abstinence compared with 33 percent of a low-dose group. Alcoholics receiving conventional therapy had a 12 percent improvement rate.

In a study of 31 cancer patients suffering from anxiety, depression and uncontrollable pain, 71 percent showed improvement in their physical and emotional status after each LSD session.

According to Yensen, researchers also observed that many cancer patients receiving LSD reported that their desire for addictive pain medicines, such as morphine, had diminished or vanished, along with the pain.

An article in the winter 1995 edition of MAPS, published by the Multidisciplinary Association for Psychedelic Studies, reports success with another hallucinogen, ibogaine, in the treatment of chemical dependencies. The article's author, Howard Lotsof, founder of NDA International Inc. — a private organization based in Staten Island, N.Y., that treats drug addicts overseas — discusses several treatment successes, including a medical doctor whose addiction to a pain medication vanished after receiving four doses of ibogaine. Lotsof reported in the article that "29 of 35 patients successfully treated with ibogaine had numerous unsuccessful experiences with other treatment modalities."

Lotsof's studies are not sanctioned by FDA, and he is not authorized to treat patients in the United States.

Members of FDA's pilot drug evaluation staff advise caution in interpreting the results of these early studies and observations. "We have to wonder: What was the quality of the drugs?" FDA's Klein said. "What other factors were involved? Were the doses adhered to? What was the outcome measured? These are the kinds of questions we need to go back and look at objectively."

Research Renewed

The current round of research activity got under way in the late 1980s, bolstered in large part by advances in the understanding of brain chemistry.

FDA has granted IND status to several psychedelic drugs in recent years. The IND status means the drugs have been studied in the laboratory for their major physical and chemical properties and tested in laboratory animals for their pharmacologic and toxic effects.

In granting IND status, FDA carefully monitors study protocols to ensure that they meet FDA's safety and scientific standards. "The studies have to be safe and conducted under controlled conditions," Klein said. "Otherwise, the research may offer questionable or, at best, minimal returns."

Because the drugs are controlled substances, scientists must apply to the Drug Enforcement Administration for a Schedule I permit in conjunction with filing an IND application with FDA. And, to receive IND approval, researchers must document that they have a suitable drug source whose manufacturing capabilities meet the agency's good manufacturing procedures. That presents a challenge because few reputable U.S. drug manufacturers make these drugs.

To get high-quality drugs, psychedelic researchers rely on European manufacturers, hospital pharmacies, and university chemistry labs.

Recruiting subjects can be a challenge, too, because in many cases, experienced psychedelic users are preferred, and their identities need to be protected for most studies.

"They're less likely to panic," said Rick Strassman, M.D., associate professor of psychiatry at the University of New Mexico. "It can happen that people get frightened."

For that reason, in these studies, subjects are closely monitored in the clinical setting by one or more health professionals. Drugs, such as Valium (diazepam), are on hand to reduce the effects of bad reactions.

The researchers foresee various uses for their research. At the University of New Mexico, where scientists are studying the effects of DMT and psilocybin in humans, lead investigator Strassman believes his work may enable scientists to develop treatments for drug overdoses.

"People on the street take these drugs," he said. "If we determine how these drugs work, perhaps we would be able to treat those who come into the emergency room because of a bad trip or panic reaction."

Other scientists say psychedelic research may serve as a way to learn more about the human brain. Writing in a 1994 National Institute on Drug Abuse report, Stephen Szera, M.D., D.Sc., former chief of the institute's biomedical research branch, said, "Recent advances in the neurosciences and cognitive sciences have created opportunities for using hallucinogens as tools in attacking the supreme mystery: How does the brain work?"

NIDA's Vocci believes that this time around, scientists may have a better chance to find the answer to this and other psychedelic research questions.

"The investigators are very serious, dedicated professionals," he said. "They're truly interested in trying to evaluate what these drugs can do."

About the Author

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