United States of America

Psilocybin in the United States

Several studies with psilocybin for relieving anxiety in those suffering from life-threatening diseases were the impetus for studying psilocybin in the US. This is also where, in 2020, a long-term follow-up study was done with participants from the New York University School of Medicine study. The researchers found that among 15 cancer patients who participated, up to 80% were still feeling the positive effects from one dose of psilocybin, up to four and a half years later.

A number of studies carried out by researchers from the Centre for Psychedelics and Consciousness Research at Johns Hopkins University have concluded that not only does psilocybin have long-term, positive effects on the depression and anxiety scores of study participants, as well as the relapse rates of participants suffering from substance misuse conditions, the abuse potential of psilocybin compares favourably with other substances such as opioids. In other words, patients are at minimal risk of developing a dependence on psilocybin relative to other drugs which are used as medicines. 

Researchers at the University of New Mexico Health Sciences Centre have instigated a pilot study for the treatment of alcohol dependence with psilocybin. The study with ten participants showed that up to nine months later they had significantly reduced their alcohol intake after two high dose psychedelic treatment sessions. 

Also widely reported is another pilot study from Matthew Johnson and colleagues at Johns Hopkins that found that 12 of the 15 participants in a smoking cessation trial were not smoking up to six months later. A follow-up study 2.5 years after the trials showed that 60% were still smoking abstinent. These numbers compare favourably versus other, often much longer, treatments that achieve up to 35% smoking abstinence.

‘I have smoked for a number of years, and I have attempted to quit on numerous occasions, and I always would go through withdrawal. I didn’t with psilocybin’                                  Study participant, Johns Hopkins University, psilocybin for smoking cessation trial.

The legality of Psilocybin Mushrooms in the United States

The Controlled Substances Act, 1971, which provides a legal framework for the US federal drugs policy, prohibits the manufacture, sale, possession or use of psilocybin in the US. While this may be the case at the federal level, a number of initiatives at the state level have resulted in the decriminalisation of the substance. Some cities in Colorado and California approved the decriminalisation of psilocybin in 2019, with the citizens of Denver becoming the first in the country to vote to decriminalise psilocybin mushrooms on 7 May 2019. The city council of Oakland, in the state of California, followed a month later, on 5 June. In January 2020, Santa Cruz, also in the state of California, became the third city in the country to decriminalise psychedelic mushrooms. As of July 2021, more than seven cities and as many states, have implemented legislation surrounding the decriminalisation of psilocybin.

According to the grassroots movement, Decriminalise Nature, there are as many as 100 other initiatives at various stages of development in cities across the US. On 6 July 2020, activists in Washington DC seeking to decriminalise psychedelics submitted a sufficient number of signatures to successfully petition for inclusion on the November ballot. The Psilocybin Service Initiative of Oregon (PSI Oregon 2020) is a 2020 ballot initiative that led Oregon to become the first state to legalise psilocybin-assisted therapies and to decriminalise personal possession of drugs (Measures 109 and 110). A two-year development process is currently ongoing to establish rules and regulations. The start of 2023 is the earliest date when applications related to the manufacture, sale and purchase of psilocybin products and services is set to commence in Oregon.

California, the most populous state in the US, has been working on decriminalisation legislation since Oakland’s victory. Senator Scott Weiner is leading this charge and has successfully secured the decriminalisation of several psychedelics (notably excluding peyote for conservation reasons) through the Senate and several committees. A vote on the Assembly floor and the Governor’s desk awaits.

 Finally, a federal bill was introduced to US Congress to decriminalise drug possession in June 2021. The Bill is still in the early stages and will go through several revisions that will take at least several months. Still, this marks the first significant signal of change for drug policy at the federal level.

LSD in the United States

Researchers at the Eleusis Benefit Corporation in New York are seeking to leverage the anti-inflammatory activity of low doses of LSD to stave off Alzheimer’s disease. The company so far has been successful in stage I clinical trials, which demonstrated the safety of doses up to 20 micrograms in geriatric populations. Next, the researchers will investigate whether the anti-inflammatory activity of LSD is neuroprotective against Alzheimer’s.

In June 2020, New York-based MindMed announced a phase IIb commercial drug trial, for the treatment of anxiety disorders, officially known as Project Lucy. The trial will focus on experiential doses of LSD, administered by a therapist. The company is aiming to submit an application for an investigational new drug (IND) with the US FDA

MDMA in the United States

In 2018, the University of California, Los Angeles (UCLA) conducted a small feasibility study (12 participants) on the impact of MDMA on the social anxiety of adults with autism. All of the participants in the study, even those who took a placebo, displayed some improvement, but patients who took the MDMA experienced a significant drop in their anxiety after the first session and another reduction after the second dose. Even six months after the treatment ended, they continued to feel considerably less anxious about social encounters.

Further north, at the Ryerson University in Toronto, researchers have conducted the first modern-day studies on MDMA and couple therapy. Of the six couples in the study, one of the partners was suffering from PTSD but both partners underwent cognitive behavioural conjoint therapy (CBCT). Both partners were happier, in a better relationship with each other, and the partner suffering from PTSD also felt relief regarding the symptoms related to PTSD.

MDMA has also been investigated as a treatment for anxiety and other psychological distress related to life-threatening illnesses. A small 2018 study at the Harbor-UCLA Medical Centre found improvements in scores of anxiety, but these results didn’t reach significance. A larger trial, with more participants, may find that MDMA can be beneficial for this patient population too.

An ongoing study, that is recruiting patients, will investigate the safety and feasibility of treating eating disorders with MDMA-assisted therapy. Specifically, the study will investigate those with anorexia nervosa restricting subtype (AN-R) and binge-eating disorder (BED). This study is also being supported by MAPS and is a phase II study that will take place in the coming year in the US and Canada.Ketamine in the United States

More than 100 clinical trials have investigated the effectiveness of ketamine for the treatment of mental health disorders. The overwhelming conclusion states that ketamine is effective in the acute treatment of all forms of depression (MDD, TRD, bipolar disorder, postpartum depression (PPD), suicidal ideation, and PTSD. The effects are usually noticeable in the first few hours and persist at a high level up to seven days later. The effectiveness of ketamine wears off in the days afterwards and some studies find that patients are back to baseline in 28 days. The lack of long-term effectiveness could be related to the different ways ketamine interacts with the brain, the lack of talk therapy in many trials, and other factors. However, ketamine’s benefit also extends to those who require immediate relief and may prefer to gain an alleviation of symptoms, without engaging in the process of talk therapy.

Two studies at the start of 2021 have added evidence for the long-term effectiveness of ketamine when administered repeatedly. The first study, from the Washington University School of Medicine, found that a 96-hour infusion of intravenous ketamine lowered depression scores for those with TRD, up to eight weeks later. The second study gave six weekly oral doses of ketamine for those suffering from suicidal ideation and found significant reductions up to four weeks after the end of the study.

A review of studies of ketamine in the treatment of depression in patients with a history of psychosis or current psychotic symptoms showed that the available literature does not support the assumption that ketamine exacerbates psychotic symptoms in those patients. The review was limited in sample size (41 patients) but it stands out because psychotic patients are excluded in nearly every other trial with psychedelics in order to limit risks.

Ketamine has been shown to be effective in the treatment of several substance use disorders. One double-blind, placebo-controlled study in December 2019 investigated the effects of ketamine in combination with motivational enhancement therapy to treat alcohol use disorder. A single ketamine infusion, in combination with talk therapy, improved the number of days the participants weren’t drinking and also reduced the number of heavy drinking days.

In March 2020, a study from Louisiana State University examined the comparative efficacy of psilocybin and ketamine in rodent models. The study found that a single administration of psilocybin, or LSD, produced persistent antidepressant-like effects in the rodent model. In contrast, ketamine produced only a transient antidepressant-like effect. The results of the study indicate that classic psychedelics may have therapeutic efficacy that is more persistent than ketamine.

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