Reclassification recommendations for drug in 'magic mushrooms'

Reclassification recommendations for drug in 'magic mushrooms'

If phase III clinical trials are successful, researchers suggest categorizing the drug as schedule IV

September 26, 2018

Science Daily/Johns Hopkins Medicine

In an evaluation of the safety and abuse research on the drug in hallucinogenic mushrooms, Johns Hopkins researchers suggest that if it clears phase III clinical trials, psilocybin should be re-categorized from a schedule I drug -- one with no known medical potential -- to a schedule IV drug such as prescription sleep aids, but with tighter control.

 The researchers summarize their analysis in the October print issue of Neuropharmacology.

 "We want to initiate the conversation now as to how to classify psilocybin to facilitate its path to the clinic and minimize logistical hurdles in the future," says Matthew W. Johnson, Ph.D., associate professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. "We expect these final clearance trials to take place in the next five years or so."

Following the Controlled Substances Act of 1970, any drug with the potential for abuse is categorized based on criteria that take into account whether the drug has accepted medical use, and its safety and the potential for abuse. Although preliminary research studies suggest that psilocybin may be effective for smoking cessation and for disorders such as cancer-specific depression and anxiety, it must clear phase III clinical trials before the Food and Drug Administration can be petitioned to reclassify it.

Studies in animals and humans both show low potential for abuse, the researchers say. When rats push a lever to receive psilocybin, they don't keep pushing the lever like they do for drugs such as cocaine, alcohol or heroin. When it comes to human studies, people who have used psilocybin typically report using it a few times across their lifetime.

As for safety, studies show it frequently falls at the end of the scales with the least harm to users and society, say the researchers. Psilocybin also is lowest in the potential for lethal overdose as there is no known overdose level.

"We should be clear that psilocybin is not without risks of harm, which are greater in recreational than medical settings, but relatively speaking, looking at other drugs both legal and illegal, it comes off as being the least harmful in different surveys and across different countries," says Johnson.

That being said, although psilocybin is relatively less harmful than other drugs and not prone to compulsive abuse, the researchers don't recommend releasing psilocybin into patients' hands even with a prescription. "We believe that the conditions should be tightly controlled and that when taken for a clinical reason, it should be administered in a health care setting monitored by a person trained for that situation," says Johnson. The researchers foresee that the process for psilocybin use in the clinic would be similar to how an anesthesiologist prescribes and administers a drug, minimizing the potential for abuse or harm.

https://www.sciencedaily.com/releases/2018/09/180926082159.htm

LSD and other psychedelics not linked with mental health problems

August 19, 2013

Science Daily/The Norwegian University of Science and Technology (NTNU)

The use of LSD, magic mushrooms, or peyote does not increase a person's risk of developing mental health problems, according to an analysis of information from more than 130,000 randomly chosen people, including 22,000 people who had used psychedelics at least once.

Researcher Teri Krebs and clinical psychologist Pål-Ørjan Johansen, from the Norwegian University of Science and Technology's (NTNU) Department of Neuroscience, used data from a US national health survey to see what association there was, if any, between psychedelic drug use and mental health problems.

The authors found no link between the use of psychedelic drugs and a range of mental health problems. Instead they found some significant associations between the use of psychedelic drugs and fewer mental health problems.

The results are published in the journal PLOS ONE and are freely available online after 19 August.

Symptoms and mental health treatment considered

The researchers relied on data from the 2001-2004 National Survey on Drug Use and Health, in which participants were asked about mental health treatment and symptoms of a variety of mental health conditions over the past year. The specific symptoms examined were general psychological distress, anxiety disorders, mood disorders, and psychosis.

Armed with this information, Krebs and Johansen were able to examine if there were any associations between psychedelic use and general or specific mental health problems. They found none.

"After adjusting for other risk factors, lifetime use of LSD, psilocybin, mescaline or peyote, or past year use of LSD was not associated with a higher rate of mental health problems or receiving mental health treatment," says Johansen.

Could psychedelics be healthy for you?

The researchers found that lifetime use of psilocybin or mescaline and past year use of LSD were associated with lower rates of serious psychological distress. Lifetime use of LSD was also significantly associated with a lower rate of outpatient mental health treatment and psychiatric medicine prescription.

The design of the study makes it impossible to determine exactly why the researchers found what they found.

"We cannot exclude the possibility that use of psychedelics might have a negative effect on mental health for some individuals or groups, perhaps counterbalanced at a population level by a positive effect on mental health in others," they wrote.

Nevertheless, "recent clinical trials have also failed to find any evidence of any lasting harmful effects of psychedelics," the researchers said, which supports the robustness of the PLOS ONE findings.

In fact, says Krebs, "many people report deeply meaningful experiences and lasting beneficial effects from using psychedelics."

"Other studies have found no evidence of health or social problems among people who had used psychedelics hundreds of times in legally-protected religious ceremonies," adds Johansen.

What's the bottom line on psychedelic use?

Psychedelics are different than most other recreational drugs. Experts agree that psychedelics do not cause addiction or compulsive use, and they are not known to harm the brain.

When evaluating psychedelics, as with any activity, it is important to take an objective view of all the evidence and avoid being biased by anecdotal stories either of harm or benefit, the researchers say.

"Everything has some potential for negative effects, but psychedelic use is overall considered to pose a very low risk to the individual and to society," Johansen says, "Psychedelics can elicit temporary feelings of anxiety and confusion, but accidents leading to serious injury are extremely rare."

"Early speculation that psychedelics might lead to mental health problems was based on a small number of case reports and did not take into account either the widespread use of psychedelics or the not infrequent rate of mental health problems in the general population," Krebs explains.

"Over the past 50 years tens of millions of people have used psychedelics and there just is not much evidence of long-term problems," she concludes.

Both researchers were supported by the Research Council of Norway.

https://www.sciencedaily.com/releases/2013/08/130819185302.htm