Johns Hopkins Medicine

“Johns Hopkins is deeply committed to exploring innovative treatments for our patients. Our scientists have shown that psychedelics have real potential as medicine, and this new center will help us explore that potential.”

- Paul B. Rothman, M.D., Dean of the Johns Hopkins University School of Medicine and CEO of Johns Hopkins Medicine.

Scientists today are entering a new era of studying a truly unique class of pharmacological compounds known as psychedelics. Although research with these compounds was first started in the 1950s and ‘60s, it abruptly ended in the early 1970s in response to unfavorable media coverage, resulting in misperceptions of risk and highly restrictive regulations.

After a decades-long hiatus, in 2000 our research group at Johns Hopkins was the first to obtain regulatory approval in the United States to reinitiate research with psychedelics in healthy, psychedelic-naive volunteers. Our 2006 publication on the safety and enduring positive effects of a single dose of psilocybin is widely considered the landmark study that sparked a renewal of psychedelic research world-wide.

Since that time, we have published further groundbreaking studies in more than 60 peer-reviewed articles in respected scientific journals. This makes Johns Hopkins the leading psychedelic research institution in the U.S., and among the few leading groups worldwide. Our research has demonstrated therapeutic effects in people who suffer a range of challenging conditions including addiction (smoking, alcohol, other drugs of abuse), existential distress caused by life-threatening disease, and treatment-resistant depression. Studying healthy volunteers has also advanced our understanding of the enduring positive effects of psilocybin and provided unique insight into neurophysiological mechanisms of action, with implications for understanding consciousness and optimizing therapeutic and non-therapeutic enduring positive effects.

At the Center for Psychedelic and Consciousness Research, researchers will focus on how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health. Upcoming studies will determine the effectiveness of psilocybin as a new therapy for opioid addiction, Alzheimer's disease, post-traumatic stress disorder (PTSD), post-treatment Lyme disease syndrome (formerly known as chronic Lyme disease), anorexia nervosa and alcohol use in people with major depression. The researchers hope to create precision medicine treatments tailored to the specific needs of individual patients.

We analyzed acute subjective drug effects (mystical, challenging, and intensity) associated with therapeutic outcomes from ten previous studies (total N=288) in which psilocybin was administered in the range 20 to 30mg/70kg (inclusive). Analyses examined the relationships between demographic variables including body weight and subjective effects in participants receiving 20 mg/70 kg (n = 120), participants receiving 30mg/70kg (n=182), and participants whose weight-adjusted dose was about 25mg (to approximate the fixed dose that is currently being evaluated in registration trials for major depressive disorder) (n=103). No significant associations were found between subjective effects and demographic variables including body weight or sex. Across a wide range of body weights (49 to 113kg) the present results showed no evidence that body weight affected subjective effects of psilocybin. These results suggest that the convenience and lower cost of administering psilocybin as a fixed dose outweigh any potential advantage of weight-adjusted dosing.

We completed the first randomized controlled trial testing the efficacy of psilocybin therapy for depression among 24 adults. Findings showed that participants who received immediate psilocybin-assisted therapy compared with delayed treatment showed improvement in blinded clinician rater–assessed depression severity and in self-reported secondary outcomes through the 1-month follow-up. In the overall sample, 71% at 1 month had a clinically significant response to the intervention, and 54% at 1 month were in remission. Findings suggest that psilocybin with therapy is efficacious in treating MDD, thus extending the results of previous studies of this intervention in patients with cancer and depression and of a nonrandomized study in patients with treatment-resistant depression.

Although several measures have been developed to examine acute psychedelic effects (e.g., mystical-type and challenging experiences), no measure assesses acute psychologically insightful experiences that may occur during psychedelic experiences. We recently developed a new measure of psychological insight and tested its psychometric properties in a large international survey study. The measure demonstrated support for several elements of reliability and validity. The measure has the potential to extend the understanding of the acute and enduring effects of psychedelics.

The claustrum, once thought to be the seat of consciousness, is a thin sheet of gray matter that reaches out to every other region in the brain. The claustrum has historically been difficult to study, and thus, its function remains mysterious to scientists. Using fMRI brain imaging techniques, CPCR researchers, in collaboration with colleagues at the University of Maryland, observed the activity and connectivity of the claustrum in 15 people after taking psilocybin or placebo. Results showed that both the default mode network and areas of the brain believed to be responsible for setting attention and switching tasks may be disrupted during the effects of psilocybin, and alterations in the claustrum may account for these changes. This study moves us one step closer to understanding the mechanisms of psilocybin in the brain.

Findings from the first study to investigate longitudinal effects on brain function after taking psilocybin suggest that psilocybin may increase emotional and brain plasticity. Brain functioning in regions related to emotions and top-down control of emotions were altered, and overall brain connectivity was increased at 1-week and 1-month after psilocybin.

Anticipating the potential that Phase 3 research may confirm the efficacy and safety of psilocybin for one or more medical disorders, the Hopkins team critically reviewed available evidence on the abuse liability of psilocybin, from chemistry to animal models to large scale government surveys, according the structure of the Controlled Substances Act. They concluded that if psilocybin is approved as medicine, placement in Schedule IV may be appropriate with additional FDA mandated risk management provisions.

First studies demonstrating sustained positive effects of psilocybin in several special populations of individuals with interest in spirituality and religious practices.

The first study to describe features of music that may support peak psychedelic experiences, and the first study to demonstrate how LSD alters the neural basis of music perception.

First study showing that pill testing services reduce harm by decreasing intended consumption of unintended or unknown substances. This research provides the first evidence regarding harm-reduction claims for such services for use in legislation and judicial cases.

The NIH awarded a grant to study the effects psilocybin on brain function. This study utilized fMRI brain imaging techniques to study the effects of psilocybin 1-day before, 1-week after, and 1-month after drug administration, and is the first study of it’s kind to study the long-term effects of psilocybin on brain function.

Largest and most rigorous study demonstrating that a single administration of psilocybin produces large and sustained decreases in depression and anxiety in patients with a life-threatening cancer diagnosis. The results of this landmark study is providing the basis for the initiation of registration trials in the United States and Europe seeking approval of psilocybin for medical treatment.

First validated psychological scale specifically designed for assessing psychologically challenging experiences with psychedelics (what are often called “bad trips” outside of clinical research). Also, first large scale survey study documenting both acute and enduring adverse experiences after taking psilocybin mushrooms in uncontrolled settings. Also in addition, the first study suggesting a relationship between challenging experiences and the personality domain of neuroticism.

First research since the 1970s using a classic psychedelic (psilocybin) to treat addiction, and the first ever study to examine a psychedelic to treat tobacco/nicotine addiction. The pilot study showed that 80% of participants were biologically verified as smoke free 6 months after psilocybin treatment. These are drastically higher than typical success rates, with the most effective medications showing success rates less than 35%.

First validated psychological scale specifically designed for assessing spiritual (mystical) subjective aspects of psychedelic experiences. Measuring mystical experience is important because research with addicted cigarette smokers, distressed cancer patients, and healthy volunteers in non-therapeutic studies have all shown that mystical experience during psilocybin sessions predicts positive behavior change at least 6 months after sessions. Investigating mystical experiences may therefore be critical to further optimizing psychedelic interventions, and understanding how psilocybin affects consciousness.

First research determining the psychoactive effects of salvinorin A in humans under blind conditions and first human research showing these effects are mediated at opioid but not serotonin-2A receptors. Salvinorin A is the psychoactive constituent of the Salvia divinorum plant from Oaxaca Mexico. This non-classic psychedelic compound is the subject of intense scientific interest as a novel, non-addictive opioid that might hold promise in the treatment of pain and in the treatment of addiction.

First study to show that a single administration of psilocybin produced enduring change in personality, which was considered to be a fixed characteristic of individuals that does not change across the lifetime. The personality domain of openness is associated with creativity in the arts and sciences.

First framework for safely shaping the new era of research. This highly cited analysis has provided guidance to researchers and Institutional Review Boards at a growing number of universities which initiated research with psychedelics. This manuscript has helped safely shepherd the growing field of psychedelic research regarding the risks of psychedelic administration and the safeguards which are critical in addressing these risks.

First research since the 1970s to administer a classic psychedelic (psilocybin) to drug naïve participants. Psilocybin led to profound experiences that 67% of participants rated as among the top 5 most meaningful experiences of their lifetime. The single psilocybin session led to positive changes in moods, attitudes, and behavior for 14 months (and possibly longer), with 64% indicating the experience increased well-being or life-satisfaction. The study also established the safety of high dose psilocybin administration.