Author: alli

How To Join a Psychedelic Clinical Trial

How To Join a Psychedelic Clinical Trial

You could be eligible to participate in a psychedelic research trial. Studies of psychedelics are at various stages, enrolling both healthy volunteers and individuals with specific mental health conditions. We’ve compiled a list here of all the current or planned clinical trials on MDMA, psilocybin, LSD, Cannabis, and more. Regulatory approvals over the last few decades gave way to MDMA and psilocybin pilot studies and clinical trials, while research around the world is exponentially growing. New investigations for the therapeutic use of psychedelics, as well as inquiries into how the brain works and what constitutes consciousness are appearing all the time.

It seems we’ve reached a new frontier where many academic scientists and investigators in private psychiatric practices are able to pursue research on psychedelics without facing opposition based on stigma or antiquated information about safety concerns. While this may still not yet be the case for many Universities, the forerunners in this field will pave the way for others by contributing evidence-based findings to the body of knowledge. Since we have better technologically advanced tools and more rigorous study designs than ever before, all research in current day is extremely valuable.

 

Background: How does a clinical trial work?

Clinical trials collect data to evaluate safety and efficacy of drugs under investigation in research. Drugs must pass through a sequence of phases or stages to become approved and available to patients. A new substance is first thoroughly tested in human cells and/or animals to gain initial information about safety and toxicity. If enough research exists in scientific journals, sometimes an already known drug like some psychedelics, can go through less animal testing or wait till later in the process to complete. After review, FDA can grant approval to test the drug in a small number of healthy individuals (phase 1). The next phase of testing involves giving a drug to people who have a disease or condition (phase 2) to evaluate safety and effectiveness to reduce symptoms. If the drug appears safe and signals the potential to be a useful treatment, then a much larger number of people are tested in phase 3 trials at multiple study sites. For the FDA to approve a new drug for a specific condition or disease, two phase 3 trials must show significant benefit that outweighs the risks or negative side effects of taking the drug. After the drug is approved and sold in the consumer market, research continues in phase 4 known as post marketing surveillance trials. Phase 4 trials collect data on long-term effectiveness and safety, costs associated with treatment compared to other drugs in the market, and safety and effectiveness of the new drug versus other available treatment options.

Directories searched for trials:  clinicaltrials.govclinicaltrialsregister.eu; ensaiosclinicos.gov.br

Following is a list of current or planned clinical trials with psychedelics (as of December 2018) in healthy individuals and in people with a specific medical condition. We searched clinical trial registries for USA, EU, and Brazil. While we’ve attempted to make this list comprehensive, new trials are emerging often and our online search may not have revealed all. We plan to periodically update this list. If you know of clinical trials not listed here, please email us at info@psychedelic.support

Jump Ahead To:

MDMA

Psilocybin

LSD

Cannabis

Ketamine

Ibogaine

Salvinorin

MDMA

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD

Open-Label Multi-Site Study of Safety and Effects of MDMA-Assisted Psychotherapy for Treatment of PTSD

Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD

Sponsor: MAPS

Population: PTSD

Location: Global

Background: The Multidisciplinary Association for Psychedelic Studies (MAPS) is recruiting participants with chronic PTSD for Phase 2/3 trials of MDMA-assisted psychotherapy at 15 study sites in the USA, Canada, and Israel. Follow the clinical trials record below to find the study site contact information.

Enrollment: Enrolling now

More Info: Open-label Clinical Trials record (US)Open-label Clinical Trials record (Canada)Phase 3 Clinical Trials record (contact sites directly, phone numbers/emails in clinicaltrials.gov record).

Learn more about safety and effectiveness from clinical research in the MDMA Investigator Brochure (2017)

 

Evaluation of MDMA on Startle Response

Sponsor: MAPS

Population: Healthy Volunteers

Location: Emory University, Atlanta, GA

Enrollment: Enrolling Now

More Info: Clinical Trial record

MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function

Sponsor: MAPS

Population: Healthy Volunteers/Hepatic Impaired Volunteers

Location: University of California, San Francisco, CA

Enrollment: Not Yet Recruiting

More Info: Clinical Trial record

Open-Label Proof of Concept Feasibility Study to Explore the Safety, Tolerability and Potential Role of MDMA-Assisted Psychotherapy for the Treatment of Detoxified Patients with Alcohol Use Disorder

Sponsor: Imperial College London

Population: Alcohol Use Disorders

Location: UK

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

3,4-Methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy in the Treatment of Post-Traumatic Stress Disorder

Sponsor: Planting Consciousness Institute in collaboration with MAPS

Population: PTSD

Location: Brazil

Enrollment: Completed

More Info: Clinical Trials record

 

Effect of Methylenedioxymethamphetamine (MDMA) on Fear Extinction

Sponsor: University Hospital, Basel, Switzerland

Population: Healthy Volunteers

Location: Basel, Switzerland

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

 

Role of Dopamine, Serotonin, and 5-HT2A Receptors in Emotion Processing

Sponsor: University Hospital, Basel, Switzerland

Population: Healthy Volunteers

Location: Basel, Switzerland

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD

Sponsor: Yale University

Population: PTSD

Location: New Haven, CT

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

Psilocybin

Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

Sponsor: John Hopkins School of Medicine in collaboration with Beckley Foundation and Heffter Research Institute

Population: Smokers

Location: Baltimore, MD

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Effects of Psilocybin on Major Depression

Sponsor: Johns Hopkins University

Population: Depression

Location: Baltimore, MD

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

The Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Religious Professionals

Sponsor: Johns Hopkins University

Population: Religious Professionals

Location: Baltimore, MD

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators

Sponsor: Johns Hopkins University

Population: Long-term Meditators

Location: Baltimore, MD

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Persisting Effects of Psilocybin

Sponsor: Johns Hopkins University in collaboration with NIDA

Population: Healthy Volunteers

Location: Baltimore, MD

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors a Study on Distress, Depression, Grief, HIV/AIDS

Sponsor: University of California San Francisco

Population: HIV/AIDS

Location: San Francisco, CA

Enrollment: Enrolling Now

More Info:  Clinical Trials record

 

A Double-blind Trial of Psilocybin-assisted Treatment of Alcohol Dependence

Sponsor: New York University (NYU) School of Medicine in collaboration with Heffter Research and University of New Mexico

Population: Alcohol Use Disorders

Location: New York, NY

Enrollment: Enrolling Now

More Info:  Clinical Trials record

 

The Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Religious Professionals

Sponsor: New York University (NYU) School of Medicine

Population: Religious Professionals

Location: New York, NY

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Psilocybin Cancer Anxiety Study

Sponsor: New York University (NYU) School of Medicine

Population: Cancer

Location: New York, NY

Enrollment: Active, Not Recruiting

More Info: Clinical Trials record

 

Psilocybin for Treatment of Obsessive Compulsive Disorder

Sponsor: University of Arizona

Population: OCD

Location: Tuscon, AZ

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

 

Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study

Sponsor: Yale University

Population: OCD

Location: New Haven, CT

Enrollment: Not Yet Recruiting

More Info:  Clinical Trials record

 

Psilocybin – Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Sponsor: Yale University in collaboration with Heffter Research Institute

Population: Depression

Location: New Haven, CT

Enrollment: Enrolling Now

More Info:  Clinical Trials record

 

Psilocybin for the Treatment of Migraine Headache Yale University

Sponsor: Yale University

Population: Migraine

Location: New Haven, CT

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Psilocybin for the Treatment of Cluster Headache

Sponsor: Yale University in collaboration with Heffter Research Institute and Cluster Headache-Trigeminal Autonomic Cephalalgia LLC

Population: Cluster Headache

Location: New Haven, CT

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Psilocybin-facilitated Treatment for Cocaine Use

Sponsor: University of Alabama at Birmingham

Population: Cocaine Addiction

Location: Birmingham, AL

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Psilocybin and Depression

Sponsor: Helsinki University

Population: Depression

Location: Helsinki, Finland

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

 

Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms in a Randomized Controlled Trial

Sponsor: Imperial College London

Population: Depression

Location: UK

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

 

The Neurobiological Effect of 5-HT2AR Modulation

Sponsor: Gitte Moos Knudsen

Population: Healthy Volunteers

Location: Rigshospitalet, Denmark

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

 

Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects

Sponsor: University Hospital, Basel, Switzerland

Population: Healthy Volunteers

Location: Basel, Switzerland

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients – Proof of Concept

Sponsor: University of Zurich

Population: Major Depression

Location: Zurich, Switzerland

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self

Sponsor: University of Zurich

Population: Healthy Volunteers

Location: Zurich, Switzerland

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (P-TRD)

Sponsor: COMPASS Pathways

Population: Treatment Resistant Depression

Location: Wolfson Research Centre, Newcastle, UK

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

LSD

LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders (LSD-assist)

Population: Anxiety

Location: University Hospital, Basel, Switzerland

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Role of the Serotonin 5-HT2A Receptor in LSD-induced Altered States of Consciousness (LDR-Study)

Sponsor: University Hospital, Basel, Switzerland

Population: Healthy Volunteers

Location: Basel, Switzerland

Enrollment: Enrolling Now

More Info: Clinical Trial record

 

Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects

Sponsor: University Hospital, Basel, Switzerland

Population: Healthy Volunteers

Location: Basel, Switzerland

Enrollment: Not Yet Recruiting

More Info: Clinical Trial record

 

Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing

Sponsor: University Hospital, Basel, Switzerland

Population: Healthy Volunteers

Location: Basel, Switzerland

Enrollment: Enrolling Now

More Info: Clinical Trial record

KETAMINE

Too many to list! search clinicaltrials.gov

CANNABIS

Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Sponsor: MAPS

Population: PTSD

Location: Phoenix, AZ

Enrollment: Complete

More Info: Clinical Trials record

 

Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress Disorder

Sponsor: Tilray in collaboration with University of British Columbia

Population: PTSD

Location: Kelowna, BC

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study

Sponsor: Wayne State University

Population: PTSD

Location: Detroit, Michigan

Enrollment: Enrolling Now

More Info: Clinical Trials record

 

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Sponsor: Wayne State University

Population: PTSD

Location: Detroit, Michigan

Enrollment: Enrolling Now

More Info: Clinical Trials record

Many more cannabis and cannabinoid trials for various psychiatric indications found at clinicaltrials.gov

IBOGAINE

Ibogaine in the Treatment of Alcoholism: a Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial

Sponsor: University of Sao Paulo

Population: Alcohol Use Disorders

Location: Ribeirao Preto, Sao Paulo, Brazil

Enrollment: Not Yet Recruiting

More Info: Clinical Trials record

SALVINORIN A

Effects of Salvinorin A in Healthy Controls

Sponsor: Yale University

Population: Healthy Volunteers

Location: West Haven, Connecticut

Enrollment: Active, not Recruiting

More Info: Clinical Trials record

Alli Feduccia, PhD
Alli Feduccia, PhD Administrator
Dr. Alli Feduccia is a Co-Founder of Psychedelic Support and a Neuropharmacologist working as a Clinical Data Scientist at MAPS Public Benefit Corporation in support of the MAPS MDMA trials.
How Psychedelics Help Neurons Grow

How Psychedelics Help Neurons Grow

A common question about the recent wave of psychedelic research is, “how do these mind-altering substances work in the brain to produce a rapid reduction of symptoms and long-lasting improvements for a variety of mental health disorders?” Beyond some scientifically well-founded hypotheses and pure speculation, we haven’t had enough experimental evidence on psychedelics to draw from to make any large claims about the mechanisms responsible for therapeutic response. MDMA and psilocybin, both showing promising results in clinical trials, are two very different drugs, in terms of how they make people feel and how they act in the brain.

Is it possible there is a common mechanism in the brain underlying the therapeutic effects of all psychedelics?

New findings published by Ly et al. in the prominent scientific journal Cell Reports are the first to show that classic psychedelics (DMT, LSD, psilocin), amphetamine analogs (MDMA, DOI), and ibogaine all converge at one target (mTor) in the brain to promote neuroplasticity [1]. This is a notable finding because depression and stress-related disorders, e.g. PTSD, can cause a loss of synaptic connectivity – the major way that neurons and supporting cells communicate [2, 3]. The researchers showed that when rodent cortical neurons were put into a dish with each of the before mentioned substances, the number and complexity of dendritic branches and arbors greatly increased, meaning the neurons were changing their structure to make new connections. You can think of a tree being sprinkled with natural fertilizer that causes bolting of new branches and leaves to support optimal functioning of the entire system. Reversal of synaptic loss is also observed with ketamine and antidepressant drugs, and thought to the primary way that they reduce depression symptoms [4, 5].

The research group at the University of California went on to show that the neuronal growth-enhancing properties of these substances occurred within a rodent brain, and not just in cell cultures. DMT infused into the prefrontal cortex of rats, a brain region that exhibits a lose in neurons in patients with neuropsychiatric illnesses, induced growth of dendritic spines comparable to ketamine. The elegant set of well-controlled experiments demonstrate that these drugs in fact do converge on a specific signaling pathway (BDNF – TrkB – mTOR) known to be involved in structural plasticity, and the effects are conserved across rodents and fruit flies. As previously documented [6, 7], the substances increase brain derived neurotropic factor (BDNF) either through the serotonin system or by enhancing glutamate levels, and now this new evidence points to how the brain is structurally and functionally modified to produce fast-acting antidepressant effects.

Neuroplasticity, and the sprouting of new dendritic spines, is the basis for new learning.

Substances that can promote acquisition of new behaviors and ways of thinking are beneficial for treating mental health disorders, and may alleviate repetitive negative loops of thoughts, excessive rumination, and enable positive behavioral change. These experiments demonstrate neuroadaptations stimulated by many different psychedelics that follow a timeframe similar to the rapid onset of therapeutic effects with lasting gains even after the drug has left the body. The authors coined a new term to describe these related compounds, which could become in vogue if these underlying mechanisms prove correct in humans. “To classify the growing number of compounds capable of rapidly promoting induced plasticity, we introduce the term “psychoplastogen,” from the Greek roots psych- (mind), -plast (molded), and -gen (producing)” [1].

As exciting as these findings are, we must be cautious when extrapolating results from rodents and flies to humans. Little research has been done in humans with psychedelics and neuroimaging techniques. More is known about ketamine, which has been shown to reverse functional connectivity impairments in patients with major depressive disorder [8]. Could the same be true for the other psychedelics? The study published in Cell Reports also doesn’t address the added component of therapy that is used in human trials of psychedelic-assisted therapy. However, if neural networks are primed for change or new learning, then self-directed or therapist-directed processing of emotional memories could possibly guide the neuronal adaptations into a direction that supports positive behavioral change. The durable outcomes after MDMA-assisted psychotherapy, for example, suggests that brain circuits have been modified in some way [9].

This rigorous, well-designed study is particularly notable in present because many scientists and physicians are still skeptical about the large effects of psychedelics shown in recent clinical trials. By understanding neurobiological mechanisms, belief of the therapeutic potential of these substances will likely rapidly propagate amongst scientific communities, as seen with ketamine and cannabis. The expanding body of knowledge on mechanisms for therapeutic response will help fine-tune treatments and possibly aid in the discovery of new drugs for use in psychiatric medicine.

  1. Ly, C. Greb, AC, Cameron, P, Wong, JM, et al. “Psychedelics Promote Structural and Functional Neural Plasticity.” Cell Reports 23 (2018): 3170-3182.
  2. Arnsten, Amy FT. “Stress signalling pathways that impair prefrontal cortex structure and function.” Nature Reviews Neuroscience10, no. 6 (2009): 410.
  3. Christoffel, Daniel J., Sam A. Golden, and Scott J. Russo. “Structural and synaptic plasticity in stress-related disorders.” Reviews in the neurosciences22, no. 5 (2011): 535-549.
  4. Browne, Caroline Ann, and Irwin Lucki. “Antidepressant effects of ketamine: mechanisms underlying fast-acting novel antidepressants.” Frontiers in pharmacology4 (2013): 161.
  5. Li, Nanxin, Boyoung Lee, Rong-Jian Liu, Mounira Banasr, Jason M. Dwyer, Masaaki Iwata, Xiao-Yuan Li, George Aghajanian, and Ronald S. Duman. “mTOR-dependent synapse formation underlies the rapid antidepressant effects of NMDA antagonists.” Science329, no. 5994 (2010): 959-964.
  6. Nichols, Charles D., and Elaine Sanders-Bush. “A single dose of lysergic acid diethylamide influences gene expression patterns within the mammalian brain.” Neuropsychopharmacology26, no. 5 (2002): 634.
  7. Young, M. B., R. Andero, K. J. Ressler, and L. L. Howell. “3, 4-Methylenedioxymethamphetamine facilitates fear extinction learning.” Translational psychiatry5, no. 9 (2015): e634.
  8. Abdallah, Chadi G., Lynnette A. Averill, Katherine A. Collins, Paul Geha, Jaclyn Schwartz, Christopher Averill, Kaitlin E. DeWilde et al. “Ketamine treatment and global brain connectivity in major depression.” Neuropsychopharmacology42, no. 6 (2017): 1210.
  9. Mithoefer, M. C., M. T. Wagner, A. T. Mithoefer, L. Jerome, S. F. Martin, and B. Yazar-Klosinski. “Durability of improvement in PTSD symptoms and absence of harmful effects or drug dependency after MDMA-assisted psychotherapy: A prospective long-term follow-up study.” J Psychopharmacol27, no. 1 (2013): 28-39.
Alli Feduccia, PhD
Alli Feduccia, PhD Administrator
Dr. Alli Feduccia is a Co-Founder of Psychedelic Support and a Neuropharmacologist working as a Clinical Data Scientist at MAPS Public Benefit Corporation in support of the MAPS MDMA trials.

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