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Ethicists question testing of hallucinogen on humans

Psychiatric researchers over the past several years have given about 100 healthy people across the nation a powerful hallucinogen, known to drug abusers as "Special K," to study psychosis, often without fully disclosing the nature of the drug or the experiments.

The studies using ketamine have involved both mentally ill and healthy people, placing them both at risk of psychotic episodes, according to documents reviewed by the Globe.

Using ketamine on healthy volunteers especially troubles some medical ethicists, because there is no possibility that healthy people will achieve any benefit to offset the risk of harm. The mentally ill, in theory, would be aided by any knowledge gained about the biology of psychosis.

Most of the ketamine experiments have been conducted at the National Institute of Mental Health in Bethesda, Md., or at NIMH-funded facilities such as the medical schools of Yale and New York University. A Boston Globe review of their research and some of the consent forms that participants are asked to sign indicates that subjects often are not being told that the drug is being given to specifically induce symptoms such as hallucinations or memory loss, or that it is abused as a psychedelic drug.

On the streets and on drug-subculture Internet sites, ketamine is known for being able to create near-death experiences, feelings of floating and other hallucinations. It recently has been used as a date-rape drug and at all-night parties known as "raves," prompting several states to make illegal possession a felony.

Some critics see these experiments as an echo of 1950s and 1960s research in which psychiatrists gave people LSD without fully informing them of the risk.

Ketamine is primarily used as an animal tranquilizer. It once was commonly used as a human anesthetic, until its hallucinogenic properties were discovered. It is also known on the streets as "KitKat" or simply "K."

In a series on psychiatric research last month, the Globe documented the harm done by the use of ketamine and other "challenge" agents to induce psychotic symptoms in people with schizophrenia, as well as from other research approaches. An additional review has revealed studies involving ketamine in more than 100 healthy people since 1994 _ and the growing illicit use of the drug.

"If this is what they are doing to normal (people), God help us with the cognitively impaired," said Adil Shamoo, a University of Maryland bioethicist and editor of the journal Accountability in Research.

A top NIMH official and a Yale psychiatrist who has conducted some of the studies said they do not think that ketamine's illicit use needs to be spelled out in informed consent forms, since the drug is still approved by the FDA as an anesthetic. Above all, the careful use of ketamine may help yield answers for some of the most devastating mental illnesses, they say.

But James Childress, a member of the National Bioethics Advisory Commission, said the illicit use of ketamine is "exactly the sort of thing that should be disclosed" to study participants.

A legislator in Florida agreed.

"If government is going to do studies on people, I think they need to tell people what they're ingesting. It seems government should have learned that lesson a long time ago," said state Rep. Tracy Stafford, a Democrat from Wilton Manors who has filed a bill to make ketamine a controlled substance.