Clinical research
What the science actually shows
Active trials and peer-reviewed studies, pulled straight from ClinicalTrials.gov and PubMed E-utilities. Updated daily. We summarize, we do not editorialize.
Active trials
30 listed- NCT07765693· today
MDMA-AT for PTSD in Young Adults With Childhood Trauma
This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT). The main questions it aims to answer are: * Is the treatment safe and feasible to administer? * Does the treatment improve PTSD symptoms? Participants will be asked to: * Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation * Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session * Attend three integration talk therapy sessions after each MDMA-AT dosing session * Attend up to three total MDMA-AT dosing sessions * Complete assessments from ba
mdma - NCT07704762· 2w ago
Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder
This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting. The trial incorporates Acceptance and Commitment Therapy (ACT) as a core therapeutic modality. Participants will receive MDMA-AT utilizing either full-dose or active-control low-dose MDMA. The trial will also assess a regional referral center model by recruiting participants locally from the National Capital Region and non-locally across the MHS.
mdma - NCT05455996· 2w ago
MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders
The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress.
mdma - NCT06066853· 1mo ago
MDMA-assisted Therapy for Fibromyalgia
Fibromyalgia is a debilitating chronic pain disorder. Based on prior research with MDMA, it can be hypothesized MDMA-assisted therapy in fibromyalgia patients may increase the range of positive emotions, interpersonal trust, and heighten the state of empathic rapport that can lead to an enhanced patient-clinician interaction and to initiate reattribution processes targeting dysfunctional thoughts towards pain. Therapeutic alliance, i.e. a positive patient-clinician relationship, is already acknowledged as an essential component for MDMA-assisted therapy. Despite its importance, the patient-clinician interaction and the neuroscience supporting patient/clinician therapeutic alliance has received almost no attention in MDMA research. The investigators will examine the potential therapeutic be
mdma - NCT07444788· 2mo ago
Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants
Participation in this study lasts approximately two weeks and includes three on-site study visits: a screening visit (approximately 2 hours), a study drug administration visit (approximately 4 hours), and a follow-up visit approximately one week later (approximately 2 hours). If participants decide to take part in the study and meet the inclusion and exclusion criteria, they will be randomly assigned to one of two groups: an experimental group or a control group. Participants will not be informed of your group assignment. Participants in the experimental group will receive the investigational substance 5-MeO-DMT at a dose of 0.2, 0.4, 0.6, or 0.8 mg/min for a total infusion duration of 30 min. Participants in the control group will receive a placebo that is indistinguishable in appearance
- NCT07288151· 3mo ago
MDMA-Assisted Massed Exposure Therapy for PTSD
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants. The main questions it aims to answer are: * Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD out
mdma - NCT07569159· 3mo ago
MDMA Therapy in Veterans With PTSD
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
mdma - NCT07555132· 4mo ago
Circulating Oxytocin Changes in Response to MDMA vs. Placebo in Adult Patients With Autism Spectrum Disorder and Matched Healthy Controls
This study is to investigate the physiological mechanism of oxytocin system stimulation using 3,4-methylenedioxymethamphetamine (MDMA) as a physiological tool (acute oxytocin releases), not as a medication. This study seeks to test whether the oxytocin response after MDMA administration is different between individuals with autism spectrum disorder and matched healthy controls.
mdma - NCT07542145· 5mo ago
MDMA Assisted Therapy for BN
This project will evaluate MDMA Assisted Therapy (MDMA-AT) assisted psychotherapy for the treatment of Bulimia Nervosa (BN) over a 10-week period. Preliminary data suggests that MDMA can facilitate heightened openness and reduce anxiety. This study will determine whether MDMA-assisted therapy can serve as a new treatment for BN. Participants are assigned to one of three groups: MDMA-AT, MDMA-AT-BN, and Standard Treatment (ST). MDMA groups include three experimental session that include dosing, which are each followed by three integrative sessions and also include 12 psychotherapy sessions. A follow-up will take place at 6-months post baseline.
mdma - NCT07118839· 5mo ago
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose ("active placebo") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psy
mdma - NCT07179913· 5mo ago
The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression
The aim of this study is to observe the antidepressant effect of low-dose esketamine in obese patients with preoperative depression and seeking bariatric surgery. We speculate that intraoperative infusion and the addition of a small dose of esketamine to the postoperative analgesic pump can help reduce the proportion of patients with depression after surgery, and may further improve postoperative recovery, reduce the use of postoperative opioids, shorten postoperative hospital stay, and improve postoperative quality of life of patients.
spravatoketamine ivketamine im - NCT07523334· 6mo ago
Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients
Esketamine is frequently used during the perioperative period for supplemental analgesia. Small sample size trials showed that subanesthetic dose esketamine may decrease postoperative neurocognitive complications. However, conflicting results exist and optimal dose of esketamine remains to be determined. This dose-exploring pilot trial is designed to evaluate the safety and efficacy of three different perioperative esketamine dosing regimens in older patients undergoing major non-cardiac surgery. The primary purpose is to explore the optimal dosing strategy that produce maximal neurocognitive benefits with minimal adverse neuropsychiatric symptoms.
spravatoketamine ivketamine im - NCT07540494· 6mo ago
Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects
The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.
- NCT03606538· 6mo ago
MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function
The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function. The main questions it aims to answer are: Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function? Researchers will compare people with abnormal liver function to people with normal liver function. Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.
mdma - NCT07494214· 7mo ago
Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants
This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect). In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. At the same time, participants will take MDMA or a placebo by mouth. This allows researchers to compare how MDMA affects the artificially created pain. A total of 20 healthy volunteers will take part in this study.
mdma - NCT07102576· 8mo ago
MDMA-Assisted Therapy for Mental Healthcare Providers
This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Participants will work with a co-therapy pair as they engage in a preparatory session, one experimental session with MDMA, and an integration session the following day.
mdma - NCT07399756· 8mo ago
Mitochondrial Function After Ketamine
The goal of this observational study is to learn about the role of mitochondria in response to S-ketamine. in individuals with Treatment-Resistant Depression. the Research Questions are 1. Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15? 2. Can changes in mitochondrial function serve as biomarkers for predicting or monitoring clinical response to S-ketamine treatment? Samples will be collected at baseline, 3 hours after the first treatment, and 6 weeks post-exposure, and compared between responders and non-responders
ketamine ivketamine imketamine oral - NCT07369102· 8mo ago
Esketamine With or Without Integration Therapy for Treatment-Resistant Depression
This study will explore the effects of esketamine (Spravato®), an FDA-approved nasal spray, on adults diagnosed with treatment-resistant depression (TRD). All participants will receive esketamine as prescribed by a healthcare professional in a clinical setting. The purpose of this research is to understand whether adding therapeutic support in the form of preparation and integration sessions - before and after the esketamine doses - can enhance the treatment experience and lead to longer-lasting improvements in mood and functioning. Participants will be randomly assigned to one of two groups: Esketamine with therapeutic support sessions (integration group) Esketamine without additional support (standard care group) Both groups will receive standard monitoring and psychiatric evaluation
spravatoketamine ivketamine im - NCT07301632· 8mo ago
Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial
This is a Health Canada regulated internal pilot study designed to assess the feasibility, tolerability, and preliminary efficacy of 3, 4-methylenedioxymethamphetamine hydrochloride capsules-AT for chronic neuropathic pain to inform a larger, fully powered multi-center study. This is an interventional, randomized, 2-arm parallel, blinded (Treating and dosing physician, Patient Outcome assessor and psychotherapist). The total study duration is 2 years. Participants will receive preparatory psychotherapy session during week 2 and week 4 followed by a combined single dosing session with psychotherapy during week 6. Integrative psychotherapy will follow at weeks 6, 8, 12, and 16. Follow up for primary clinical endpoint at week 16; final follow up for secondary clinical endpoint at 16-weeks.
- NCT07469098· 9mo ago
Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events
The goal of this clinical trial is to evaluate the safety, tolerability and effectiveness of group-based MDMA-assisted therapy compared to individual MDMA-assisted therapy in participants with PTSD, who were diagnosed following the events of 7 October 2023. The main questions it aims to answer are: safety and tolerability? effectiveness? Researchers will compare group-based MDMA-assisted therapy to individual MDMA-assisted therapy to see if group-based MDMA-assisted therapy is not inferior to individual MDMA-assisted therapy, in terms of safety and effectiveness. Participants will be randomized to one of two study arms: group-based MDMA-assisted therapy or individual MDMA-assisted therapy receive MDMA HCl administered orally in a divided dose. Participate in preparatory sessions, MDMA dos
mdma - NCT07317232· 10mo ago
Ayahuasca, Esketamine and Premenstrual Symptoms
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms.
spravatoketamine ivketamine im - NCT07317206· 10mo ago
Ayahuasca, Esketamine and PTSD
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine in patients with posttraumatic stress disorder.
spravatoketamine ivketamine im - NCT07303907· 10mo ago
A Phase 2A Trial of DT402 for Autism Spectrum Disorder
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
- NCT06989957· 1y ago
Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)
The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet
psilocybin orpsilocybin comdma - NCT05783817· 1y ago
MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study)
The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive disorder (OCD).
mdma - NCT06683014· 1y ago
MDMA in Borderline Personality Disorder
The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.
mdma - NCT06905652· 1y ago
Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants
Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA has been investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.
mdma - NCT06418178· 1y ago
Dose Optimization of MDMA-Assisted Therapy for PTSD
This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.
mdma - NCT06884514· 1y ago
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it (set), or the environment in which psilocybin is taken (setting). Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favorable long-term outcomes in patients experimentally treated with psilocybin or similar substances for the treatment of depression. The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine (MDMA) reliably induces positive mood, euphoria, comfort, empathy, and feelings of trust. If admin
psilocybin orpsilocybin comdma - NCT07050212· 1y ago
Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.
spravatoketamine ivketamine im
Recent publications
30 listed- PubMedPMID 42778030· today
Feasibility and tolerability of virtual reality during esketamine treatment: A pilot study.
Published 2027 Jan 1 in J Affect Disord. Authors: Curran E, Kumpf KT, Ansari M et al.
- PubMedPMID 42686072· today
A response to the letter to editor: Breaking the chains of depression: A systematic review and meta-analysis of psilocybin therapy.
Published 2026 Dec 15 in J Affect Disord. Authors: Khan FA, Pandupuspitasari NS, Tencomnao T et al.
- PubMedPMID 42624219· today
Suicidal ideation covaries with depressive severity during six-month real-world esketamine treatment in a cohort enriched for borderline personality disorder.
Published 2026 Dec 1 in J Affect Disord. Authors: Martiadis V, Raffone F, Mazzoni F et al.
- PubMedPMID 42575192· today
Exploratory non-randomized clinical trial of subcutaneous esketamine in treatment-resistant depression: Effects of ketamine-assisted psychotherapy.
Published 2026 Dec 1 in J Affect Disord. Authors: Varela YM, Cavalcanti-Ribeiro P, de Sousa GM et al.
- PubMedPMID 42808010· today
Treatments for Individuals with Suicidal Thoughts: Use, Indications, and Helpfulness.
Published 2026 Dec in J Affect Disord Rep. Authors: Ballard ED, Hafermann H, Hurst K et al.
- PubMedPMID 42762641· today
Cognitive effects of ketamine and esketamine treatment for major depressive and bipolar disorder: a systematic review.
Published 2026 Dec in Psychiatry Res. Authors: Xiao K, Woo Y, Dri CE et al.
- PubMedPMID 42575191· today
Discordant signals: How outcome measurement shapes interpretation of ketamine response in treatment-resistant depression.
Published 2026 Dec 1 in J Affect Disord. Authors: Vazquez G, Kang MJY, Gutierrez G
- PubMedPMID 42571376· today
Ketamine preserves perineuronal nets in chronic stressed mice brain through the inhibition of microglia activation.
Published 2026 Dec in IBRO Neurosci Rep. Authors: Yang J, Huang T, Wang M et al.
- PubMedPMID 42745658· today
Opioid-free analgesia with esketamine-dexmedetomidine versus opioid-based analgesia after gynaecological laparoscopic surgery: a double-blind, randomized, controlled trial.
Published 2026 Dec in Ann Med. Authors: Ren Y, Li YT, Yin QL et al.
- PubMedPMID 42693883· today
Esketamine vs. sufentanil for quality of recovery after outpatient gynecological surgery: a randomized clinical trial.
Published 2026 Dec in Ann Med. Authors: Wang XL, Li YN, Ma QL et al.
- PubMedPMID 42492692· today
Rapid clinical and EEG microstate changes 24 h after intranasal esketamine in major depressive disorder with suicidal ideation: a prospective paired study.
Published 2026 Dec 1 in J Affect Disord. Authors: Gu T, Zhang J, Wang R et al.
- PubMedPMID 42657795· today
Intraoperative esketamine for postoperative analgesia and depression in pancreatic cancer surgery: protocol for a multicenter randomized controlled trial.
Published 2026 Dec in Ann Med. Authors: Chong YZ, Sun YE, Ma X et al.
- PubMedPMID 42575195· today
Intravenous Ketamine reduces psychological pain in suicidal inpatients: A secondary analysis of a six-week randomized placebo-controlled trial.
Published 2026 Dec 1 in J Affect Disord. Authors: Baryshnikov I, Demattei C, Abbar M et al.
- PubMedPMID 42468852· today
DATAd: A new communication and tracking system for treatment-resistant depression.
Published 2026 Dec 1 in J Affect Disord. Authors: Conroy SK, Voytenko VL, Docherty AR et al.
- PubMedPMID 41810848· today
High-flow versus standard nasal cannula oxygenation for post-procedural quality of recovery in older adults undergoing sedated ERCP: protocol for a randomized controlled trial.
Published 2026 Dec in Ann Med. Authors: Huang L, Gui WH, Zhu Y et al.
- PubMedPMID 41663054· today
Letter regarding "efficacy of esketamine in reducing nausea and vomiting after anesthesia: a systematic review and meta-analysis of randomized controlled trials".
Published 2026 Dec in Ann Med. Authors: Mao M, Chen J
- PubMedPMID 41919730· today
Trauma re-experiencing episodes during esketamine treatment in patients with treatment-resistant depression and comorbid PTSD: a retrospective case series.
Published 2026 Dec in Eur J Psychotraumatol. Authors: Rothärmel M, Mekaoui L, Kazour F et al.
- PubMedPMID 42521097· today
Dimensional effect profiles in treatment-resistant depression: A naturalistic, prospective head-to-head comparison of arTMS, esketamine nasal spray, and oral brexpiprazole.
Published 2026 Dec 1 in J Affect Disord. Authors: d'Andrea G, Cavallotto C, Susini O et al.
- PubMedPMID 42484088· today
Effects of low-dose esketamine on early quality of recovery following minimally invasive esophagectomy: a multicenter, randomized controlled study.
Published 2026 Dec in Ann Med. Authors: Zhang H, Yin F, Li L et al.
- PubMedPMID 42396903· today
Effects of sub-anesthetic doses of esketamine on immune function and postoperative negative emotions in acoustic neuroma patients: a randomized clinical trial.
Published 2026 Dec in Ann Med. Authors: Chen Z, Wang Y, Cong P et al.
- PubMedPMID 42879530· today
Longitudinal peripheral DNA methylation remodeling following ketamine-assisted psychotherapy in major depressive disorder.
Published 2026 Dec in Epigenetics. Authors: Nepton A, Faber SC, Kaminsky Z et al.
- PubMedPMID 41814842· today
Perioperative Ketamine and Esketamine for Enhanced Recovery After Surgery (ERAS): A Systematic Review.
Published 2026 Dec in J Invest Surg. Authors: Xu M, Zhu R, She YJ et al.
- PubMedPMID 42562064· today
Correspondence: "Breaking the chains of depression: A systematic review and meta-analysis of psilocybin therapy".
Published 2026 Dec 1 in J Affect Disord. Authors: Hörnqvist N
- PubMedPMID 41607108· today
Effects of nine sedative-analgesic combinations on fatigue after gastrointestinal endoscopy: a randomized controlled 3 × 3 factorial trial protocol.
Published 2026 Dec in Ann Med. Authors: Huang L, Xu LN, Kuai LY et al.
- PubMedPMID 42846850· today
Efficacy and safety of ketamine for post-traumatic stress disorder: A systematic review with narrative synthesis and consideration of military and veteran populations.
Published 2026 Dec in PCN Rep. Authors: Ivasyutyn M, Bhakta S
- PubMedPMID 42748866· today
Clinical correlates of non-responders to ketamine in terms of self-assessed life engagement among treatment-resistant depression patients.
Published 2026 Dec in J Psychiatr Res. Authors: Walaszek M, Cubała WJ, Pastuszak K et al.
- PubMedPMID 42731235· today
Beyond symptom reduction: Intranasal esketamine is associated with improved quality of life in treatment-resistant depression.
Published 2026 Dec in J Psychiatr Res. Authors: Pompili M, Sarubbi S, Di Biase G et al.
- PubMedPMID 42723442· today
Effects of Esketamine on Postoperative Hospital Anxiety and Depression Scale Scores in Patients Undergoing Laparoscopic Radical Resection for Colorectal Cancer.
Published 2026 Dec in J Invest Surg. Authors: He L, Sun Z, Guo Q et al.
- PubMedPMID 41454547· today
Efficacy of esketamine in reducing nausea and vomiting after anesthesia: a systematic review and meta-analysis of randomized controlled trials.
Published 2026 Dec in Ann Med. Authors: Tang L, Qu S, Du Z et al.
- PubMedPMID 41630466· today
Letter to the editor regarding: Efficacy of esketamine in reducing nausea and vomiting after anesthesia: a systematic review and meta-analysis of randomized controlled trials.
Published 2026 Dec in Ann Med. Authors: Xia JY, Shen QH
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