Psychedelic Trials

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)
This double-blind, placebo-controlled trial (n=160) aims to evaluate the efficacy and safety of Psilocybin-Assisted Psychotherapy (25mg) in adults with Alcohol Use Disorder (AUD).
Status: Active, not recruiting
Start date: 2022-06-01
Phase II
Blinded
160 participants
Interventional
Pilot study for the rapid alleviation of depression in depressed alcohol dependent persons using ketamine
This randomised controlled trial (n=24) investigates the rapid alleviation of depression in individuals with coexisting alcohol dependence (AUD), utilising ketamine at sub-anaesthetic doses (7-140mg/70kg intramuscular).
Status: Not yet recruiting
Start date: 2010-09-01
Phase II
Blinded
24 participants
Interventional
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
This double-blind, randomized, placebo-controlled trial (n=62) aims to determine the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy (30mg) as a complementary intervention during inpatient rehabilitation for severe alcohol use disorder (AUD).
Status: Not yet recruiting
Start date: 2024-01-15
Phase II
Blinded
62 participants
Interventional
Psilocybin vs Ketamine for Alcohol Use Disorder (Psi vs Ket)
This double-blind, randomised, active-comparator trial (n=80) will study the effects of psilocybin (30mg) versus ketamine (52.5mg/70kg) for alcohol use disorder (AUD).
Status: Not yet recruiting
Start date: 2024-06-01
Phase II
Blinded
80 participants
Interventional
Active-controlled trial of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder
This interventional trial (n=80) aims to investigate the effectiveness of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder (AUD).
Status: Not yet recruiting
Start date: 2022-03-01
Phase II
Blinded
80 participants
Interventional
MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder (MPATHY)
This Phase II interventional trial (n=120) explores the effectiveness of MDMA-assisted (8-160mg) prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder (AUD).
Status: Recruiting
Start date: 2023-09-19
Phase II
Blinded
120 participants
Interventional
The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
This double-blind, randomized, placebo-controlled, parallel-group laboratory trial (n=63) conducted by Yale University aims to determine the effects of DMT (14-21mg/70kg/min) infusions, in conjunction with psychotherapy, on Alcohol Use Disorder (AUD).
Status: Not yet recruiting
Start date: 2024-03-17
Phase I
Blinded
63 participants
Interventional
Ketamine for Combined Depression and Alcohol Use Disorder (KeDA)
This triple-blinded, randomised, active, placebo-controlled trial (n=34) will investigate the effects of ketamine in combination with standard inpatient addiction therapy for adults suffering from depression and alcohol use disorder (AUD).
Status: Not yet recruiting
Start date: 2024-01-01
Phase I
Blinded
34 participants
Interventional
Psilocybin in Alcohol Use Disorder With Comorbid Depression (PAD)
This randomised, double-blind trial (n=30) is set to examine the feasibility, acceptability, and preliminary effectiveness of psilocybin therapy (25mg, 2x) in treating alcohol use disorder (AUD) with comorbid depression after withdrawal, alongside standard treatment.
Status: Not yet recruiting
Start date: 2024-01-01
Not Applicable
Blinded
30 participants
Interventional
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
This double-blind, randomized, placebo-controlled Phase II trial (n=200) investigates the therapeutic neural mechanisms of psilocybin (30mg) in patients with alcohol use disorder (AUD).
Status: Not yet recruiting
Start date: 2024-07-01
Phase II
Blinded
200 participants
Interventional
Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial
This randomized, double-blinded, placebo-controlled clinical trial (n=100) will investigate the potential of a single administration of psilocybin to reduce alcohol intake in patients with alcohol use disorder (AUD).
Status: Active, not recruiting
Start date: 2020-12-16
Phase II
Blinded
100 participants
Interventional
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
This open-label proof of concept feasibility study (n=20), sponsored by Imperial College London, explores the safety, tolerability, and potential role of MDMA-assisted psychotherapy in treating detoxified patients with alcohol use disorder (AUD).
Status: Unknown status
Start date: 2017-01-03
Phase II
Open
20 participants
Interventional
Ketamine-assisted psychological therapy to reduce alcohol relapse
This double-blind, randomised, controlled trial (n=280) will investigate the efficacy of ketamine-assisted psychological therapy in severe alcohol use disorder (AUD) patients.
Status: Not yet recruiting
Start date: 2023-08-30
Phase III
Blinded
280 participants
Interventional
Ketamine for the Treatment for Alcohol Use Disorder in the ED
This pilot double-blind, placebo-controlled randomized clinical trial (n=50) aims to assess the safety and preliminary efficacy of ketamine as a treatment for individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED).
Status: Recruiting
Start date: 2023-10-25
Phase II
Blinded
49 participants
Interventional
An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder
This open-label, Phase IIa study (n=12) evaluates the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 (5-MeO-DMT) combined with relapse prevention psychological support for patients with Alcohol Use Disorder (AUD).
Status: Recruiting
Start date: 2023-05-30
Phase II
Open
12 participants
Interventional
Inpatient Single Dose Interventions for Alcohol Use Disorder
This interventional, randomised pilot feasibility study (n=44, age 18-65) aims to assess the potential of single-dose interventions (including ketamine) in reducing re-admissions for hospitalised patients with severe alcohol use disorder (AUD).
Status: Completed
Start date: 2022-01-19
Phase I
Blinded
44 participants
Interventional
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder (PAP-AUD)
This randomised, controlled clinical trial (n=128) aims to investigate whether a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with alcohol use disorder (AUD).
Status: Not yet recruiting
Start date: 2024-01-01
Phase II
Blinded
128 participants
Interventional
Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder
This double-blind, randomized, active-comparator controlled trial (n=20) will compare the effects of psilocybin-assisted psychotherapy with ketamine-assisted psychotherapy in individuals struggling with alcohol use disorder (AUD).
Status: Recruiting
Start date: 2024-02-02
Phase II
Blinded
20 participants
Interventional
MDMA for AUD/​PTSD Comorbidity (MDMA)
This open-label, phase 2 trial (n=18) will investigate the safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in military veterans with co-occurring Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
Status: Not yet recruiting
Start date: 2023-09-01
Phase II
Open
18 participants
Interventional
A Phase III Trial Investigating the Effects of Ketamine-Assisted Therapy in the Treatment of Alcohol Use Disorder
Awakn Life Sciences has announced a Phase III trial to explore the effects of ketamine-assisted therapy in the treatment of alcohol use disorder (AUD).
Status: Planned
Start date: 2023-05-01
Phase III
Blinded
280 participants
Interventional
LSD Treatment for Persons With Alcohol Use Disorder (LYSTA)
This double-blind study (n=128) will investigate if LSD (150-250μg, 2x) will be effective in treating alcoholism (AUD). This will be compared to an 'active' placebo of 10μg LSD. The study, when conducted, will be the largest modern study of LSD for AUD.
Status: Not yet recruiting
Start date: 2023-01-01
Phase II
Blinded
128 participants
Interventional
Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder
This pilot study will collect preliminary data that measures the effects of psychedelic-assisted psychotherapy on patients struggling with alcohol use.
Status: Not yet recruiting
Start date: 2022-08-01
Phase II
Open
20 participants
Interventional
Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder
The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD).
Status: Recruiting
Start date: 2022-10-10
Phase II
Blinded
90 participants
Interventional
Ketamine for Reduction of Alcoholic Relapse (KARE)
96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple psychoeducation.
Status: Completed
Start date: 2016-10-10
Phase II
Blinded
96 participants
Interventional
Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder
The purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD).
Status: Recruiting
Start date: 2021-04-14
Phase II
Blinded
90 participants
Interventional
Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition, the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for the treatment of AUD.
Status: Not yet recruiting
Start date: 2021-1-20
Phase II
Open
10 participants
Interventional
Bristol Imperial MDMA in Alcoholism Study
This open-label study (n=14) investigated the effect of MDMA-assisted psychotherapy in treating patients with alcoholism (Alcohol Use Disorder, AUD). The patients were first detoxified and subsequently underwent eight weeks of therapy, including two high doses of MDMA (125mg + 62.5mg booster) plus therapy.
Status: Completed
Start date: 2018-4-18
Phase I
Open
14 participants
Interventional
Mescaline for AUD
Journey Collab plan to assess the use of mescaline for treating alcohol use disorder (AUD) in the clinical trial process.
Status: Planned
Start date: 2022-03-14
Not Applicable
Open
15 participants
Interventional
Phase IIb, a double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of MDMA-assisted psychotherapy for Alcohol Use Disorder
Awakn Life Sciences are now planning to conduct a Phase II study exploring the safety and efficacy of MDMA-assisted psychotherapy for Alcohol Use Disorder (AUD).
Status: Planned
Start date: 2022-01-31
Phase II
Open
20 participants
Interventional
Open-label safety, tolerability and proof-of-concept study investigating the potential role for MDMA-Assisted Psychotherapy in treating patients with alcohol use disorder
This Phase I study assessed the safety and efficacy of using MDMA-assisted psychotherapy to treat alcohol use disorder (AUD).
Status: Completed
Start date: 2020-4-20
Phase I
Open
14 participants
Interventional

Find Psychedelic Trials

Browse through all psychedelic trials that have been done or are ongoing. These trials, usually double-blind, placebo-controlled studies, are the core of psychedelic research. The outcome of these trials will determine the future of psychedelics as medicine.

The trials included in our database come from ClinicalTrials.Gov and from the various companies pursuing psychedelics as medicine. Most of the trials have been funded by universities, though companies and governments are currently starting to ramp up their involvement.

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