Psychedelic drugs should be legally reclassified so that researchers can more easily test their therapeutic potential in clinical psychiatry and other areas of medicine, experts say.

Legal restrictions placed on medical use of lysergic acid diethylamide (LSD), psilocybin, and other psychedelic drugs make clinical trials nearly impossible, and authorities should “downgrade their unnecessarily restrictive” Class A, Schedule I classification, writes James Rucker, MRCPsych, psychiatrist and honorary lecturer at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London, writes in an essay published online May 26 in the BMJ.

These drugs were extensively used and researched in clinical psychiatry before their prohibition in 1967, he notes, with many trials suggesting benefit in various psychiatric disorders. However, research ended after 1967.

In the United Kingdom, psychedelic drugs were legally classified as Schedule I drugs, having “no accepted medical use and the greatest potential for harm, despite the research evidence to the contrary,” Dr Rucker notes. Psychedelic drugs also fall under the Schedule I classification in the United States.

No Evidence of Harm

Psychedelics remain more legally restricted than heroin and cocaine, yet “no evidence indicates that psychedelic drugs are habit forming; little evidence indicates that they are harmful in controlled settings; and much historical evidence shows that they could have use in common psychiatric disorders,” Dr Rucker notes.

Several recent studies suggest psychedelics have “clinical efficacy in anxiety associated with advanced cancer, obsessive compulsive disorder, tobacco addiction, alcohol addiction, and cluster headaches,” he notes.

As reported by Medscape Medical News, a study published earlier this year found that any lifetime use of classic psychedelic drugs, including LSD and mescaline, was associated with lower likelihood of psychological distress, suicidal thinking, suicidal planning, and suicide attempts.

But large, controlled trials, which are needed to truly investigate their therapeutic potential, are made “almost impossible by the practical, financial and bureaucratic obstacles” imposed by their Schedule I classification, Dr Rucker says. In the United Kingdom, to hold a Schedule I drug, institutions are required to have a license, which is costly. Currently, only four hospitals hold such licenses, which come with regular police or home office inspections and onerous rules on storage and transport.

Dr Rucker calls on the UK Advisory Council on the Misuse of Drugs and the 2016 UN General Assembly Special Session on Drugs to recommend that psychedelics be reclassified as Schedule II compounds to enable a “comprehensive, evidence based assessment of their therapeutic potential.”

###

Peter Hendricks, PhD, Department of Health Behavior, University of Alabama at Birmingham, told Medscape Medical News he “completely agrees that the medical or scientific rationale for placing psychedelics in Schedule I is poor…. Much of the contemporary research has focused on psilocybin, and the existing evidence suggests that this substance should be designated no more restrictive than Schedule III,” Dr Hendricks said.

Echoing that, Teri Suzanne Krebs, PhD, told Medscape Medical News, “rules should be changed or reevaluated to make it easier to use psychedelics in research and in medical practice.”

Dr Krebs is researcher and board leader of EmmaSofia, a nonprofit company based in Oslo, Norway, that works to protect the human rights of people who use psychedelics and to expand access to quality-controlled psychedelics for medical purposes.

“In my experience,” said Dr Krebs, “there are very few people who are actively opposed to psychedelics, although there are some misunderstandings to clear up. The old opposition to psychedelics was based on an outdated worldview that valued conformity over self-expression and was skeptical to anything remotely ‘mystical’ or ‘spiritual.’ Today, the situation is very different than 50 years ago; for one thing, meditation and mindfulness now are accepted by psychiatrists, scientists, and the general public. There is a lot of curiosity and interest in psychedelics,” she noted.

The “main misunderstanding,” Dr Krebs said, is that “many people assume that psychedelics must be addictive because they are controlled substances. Actually, psychedelics are not considered to cause addiction, dependence, or compulsive use.”

One problem in terms of developing psychedelics for use as therapeutic agents has been “lack of pharmaceutical company support, because all patents on LSD and psilocybin expired decades ago, and the therapy model involves only a few doses rather than daily use. No pharmaceutical company has ever applied for marketing approval for psychedelics, so psychedelics have fallen through the cracks of the marketing approval system,” Dr Krebs told Medscape Medical News.

She said that organizations working to reform policies on psychedelics include the Global Commission on Drug Policy (led by Kofi Annan and others), the Open Society Foundation, the Transform Drug Policy Foundation, the Drug Policy Alliance, the Beckley Foundation, the Multidisciplinary Association of Psychedelic Studies, and the UK Psychedelic Society.

Dr Krebs said EmmaSofia is collaborating with a pharmaceutical manufacturer in Norway that has a license to produce controlled substances. “We plan to manufacture pharmaceutical psilocybin and MDMA and make these substances available for free or low cost for research, medicine, and other legal purposes.” The organization is running a crowdfunding campaign to raise funds for this project.

In the United States, “current efforts are directed toward gaining FDA approval for conditions such as end-of-life distress and addiction, which should lead to a change in schedule, though legal matters…are complicated,” Dr Hendricks told Medscape Medical News.

Dr Rucker, Dr Krebs, and Dr Hendricks report no relevant financial relationships.

###
BMJ. Published online May 26, 2015