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.gov; clinicaltrialsregister.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

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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

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Background: How does a clinical trial work

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

Evaluation of MDMA on Startle Response

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

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

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

Effect of Methylenedioxymethamphetamine (MDMA) on Fear Extinction

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

The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD

Psilocybin

Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

Effects of Psilocybin on Major Depression

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

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

Persisting Effects of Psilocybin

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

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

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

Psilocybin Cancer Anxiety Study

Psilocybin for Treatment of Obsessive Compulsive Disorder

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

Psilocybin – Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Psilocybin for the Treatment of Migraine Headache Yale University

Psilocybin for the Treatment of Cluster Headache

Psilocybin-facilitated Treatment for Cocaine Use

Psilocybin and Depression

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

The Neurobiological Effect of 5-HT2AR Modulation

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

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

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

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

LSD

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

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

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

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

KETAMINE

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)

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

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

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

IBOGAINE

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

SALVINORIN A

Effects of Salvinorin A in Healthy Controls

Published by

Alli Feduccia, PhD

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