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MDMA

Trials registered
107
Completed
60
Posted safety data
23
Participants analysed for safety
1,217
Keyshare of the arm affected26/50 = affected / analysedSeriousflagged by the trial as life-threatening, or leading to hospitalisation, disability or deathn = analysed for safety (not enrolled)
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A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

NCT04077437Phase 3121 enrolledResilient PharmaceuticalsResults posted Oct 2023

Observation window: During the Treatment Period from the first Experimental Session to the last Integrative Session (approximately 12 weeks)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.

Adverse event
MDMA-assisted Therapy
n = 53
Placebo With Therapy
n = 51
Overall
Serious adverse events
0/530%
0/510%
Any non-serious event
53/53100%
49/5196%
Deaths
0/530%
0/510%
Most frequent events
Headache
Nervous system disorders
38/5372%
31/5161%
Muscle tightness
Musculoskeletal and connective tissue disorders
31/5358%
13/5125%
Nausea
Gastrointestinal disorders
24/5345%
11/5122%
Suicidal ideation
Psychiatric disorders
18/5334%
21/5141%
Decreased appetite
Metabolism and nutrition disorders
19/5336%
5/5110%
Insomnia
Psychiatric disorders
19/5336%
15/5129%
Hyperhidrosis
Skin and subcutaneous tissue disorders
18/5334%
3/516%
Dizziness
Nervous system disorders
15/5328%
8/5116%
Anxiety
Psychiatric disorders
15/5328%
12/5124%
Fatigue
General disorders
14/5326%
9/5118%
Feeling hot
General disorders
14/5326%
6/5112%
Feeling cold
General disorders
11/5321%
3/516%
showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

NCT03537014Phase 3100 enrolledResilient PharmaceuticalsResults posted Sep 2021

Observation window: During the Treatment Period from the first Experimental Session to the Termination visit (approximately 18 weeks)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least severe PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.

Adverse event
MDMA-assisted Therapy
n = 46
Placebo With Therapy
n = 44
Overall
Serious adverse events
0/460%
2/445%
Any non-serious event
46/46100%
44/44100%
Deaths
0/460%
0/440%
Most frequent serious events
Suicide Attempt
Psychiatric disorders
0/460%
1/442%
Suicidal Ideation
Psychiatric disorders
0/460%
1/442%
Other events
Headache
Nervous system disorders
33/4672%
24/4455%
Muscle Tightness
Musculoskeletal and connective tissue disorders
28/4661%
6/4414%
Decreased Appetite
Metabolism and nutrition disorders
24/4652%
5/4411%
Suicidal Ideation
Psychiatric disorders
21/4646%
21/4448%
Insomnia
Psychiatric disorders
20/4643%
13/4430%
Anxiety
Psychiatric disorders
15/4633%
17/4439%
Nausea
Gastrointestinal disorders
14/4630%
5/4411%
Fatigue
General disorders
14/4630%
14/4432%
Hyperhidrosis
Skin and subcutaneous tissue disorders
10/4622%
1/442%
Feeling Cold
General disorders
9/4620%
3/447%
showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

NCT04714359Phase 387 enrolledResilient PharmaceuticalsResults posted Nov 2024

Observation window: From baseline to end of follow up (approximately 18 weeks)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible dose of MDMA (120 or 180 mg MDMA HCl) with therapy in three sessions? Participants will undergo three preparatory therapy sessions without any study drug, then three MDMA-assisted therapy sessions with a flexible dose of 80 or 120 mg, followed by three integrative therapy sessions without study drug after each MDMA-assisted therapy session.

Adverse event
Pre-Treatment MDMA-Assisted Therapy
n = 85
On Day 0, 1, or 2 MDMA-Assisted Therapy
n = 85
Treatment-Emergent Adverse Events MDMA-Assisted Therapy
n = 85
Follow-Up MDMA-Assisted Therapy
n = 85
Overall
Serious adverse events
0/850%
0/850%
3/854%
1/851%
Any non-serious event
51/8560%
84/8599%
84/8599%
15/8518%
Deaths
0/850%
0/850%
0/850%
0/850%
Most frequent serious events
Abdominal sepsis
Infections and infestations
––
1/851%
0/850%
Colonic abscess
Infections and infestations
––
1/851%
0/850%
Diverticular perforation
Gastrointestinal disorders
––
1/851%
0/850%
Diverticulitis
Infections and infestations
––
1/851%
0/850%
Lymphadenopathy
Blood and lymphatic system disorders
––
1/851%
0/850%
Procedural pain
Injury, poisoning and procedural complications
––
1/851%
0/850%
Retinal detachment
Eye disorders
––
0/850%
1/851%
Other events
Muscle tightness
Musculoskeletal and connective tissue disorders
1/851%
50/8559%
50/8559%
0/850%
Headache
Nervous system disorders
7/858%
43/8551%
49/8558%
1/851%
Nausea
Gastrointestinal disorders
4/855%
33/8539%
38/8545%
1/851%
Insomnia
Psychiatric disorders
4/855%
25/8529%
33/8539%
0/850%
Fatigue
General disorders
1/851%
20/8524%
32/8538%
2/852%
showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

Effects of MDMA on Emotional and Social Memories

NCT03050541NA84 enrolledUniversity of ChicagoResults posted Jun 2018
Study summary · from ClinicalTrials.gov

The purpose of this study is to examine the effects of MDMA on encoding and retrieval of emotional and social memories in healthy young adults. The study will explore the effects on memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.

Adverse event
Healthy Adult Volunteers-Oral MDMA at Memory Encoding
n = 20
Healthy Adult Volunteers-Oral MDMA at Memory Retrievial
n = 20
Healthy Adult Volunteers-Placebo at Both Sessions
n = 0
Overall
Serious adverse events
0/200%
0/200%
–
Any non-serious event
0/200%
0/200%
–
Deaths–––

Effects of MDMA on Social and Emotional Processing

NCT01849419NA65 enrolledUniversity of ChicagoResults posted Dec 2014

Observation window: Reporting occurred for the full length of the study. But no adverse events occurred.

Study summary · from ClinicalTrials.gov

The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory animals, the public health implications of ecstasy use may be substantial. Certain subjective effects of this drug distinguish it from other stimulants, and may contribute to its widespread use: That is, users report that ecstasy produces profound feelings of empathy and closeness to others. These so-called 'empathogenic' effects, which may reflect the distinctive neurochemical profile of action of the drug, have yet to be characterized in controlled laboratory studies. The investigators propose to characterize the effects of MDMA on measures of social and emotional processing that may contribute to this 'empathogenic' profile, including measures of emotion recognition, emotional responsiveness and sociability. The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin will be used because it appears to produce pro-social behavioral effects resembling those attributed to MDMA.

Adverse event
Single Group
n = 65
Overall
Serious adverse events
0/650%
Any non-serious event
0/650%
Deaths–

Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

NCT03282123Phase 238 enrolledResilient PharmaceuticalsResults posted Jul 2021

Observation window: All treatment-emergent adverse events until end of study (approximately 5 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD. The main question it aims to answer is: Do three open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by three sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Adverse event
MDMA-assisted Psychotherapy
n = 33
Overall
Serious adverse events
1/333%
Any non-serious event
33/33100%
Deaths
0/330%
Most frequent serious events
Suicide attempt
Psychiatric disorders
1/333%
Other events
Headache
Nervous system disorders
22/3367%
Muscle Tightness
Musculoskeletal and connective tissue disorders
18/3355%
Nausea
Gastrointestinal disorders
11/3333%
Insomnia
Psychiatric disorders
11/3333%
Anxiety
Psychiatric disorders
9/3327%
Suicidal Ideation
Psychiatric disorders
9/3327%
Fatigue
General disorders
8/3324%
Nystagmus
Nervous system disorders
8/3324%
Dizziness
Nervous system disorders
5/3315%
Abdominal Discomfort
Gastrointestinal disorders
4/3312%
Decreased Appetite
Metabolism and nutrition disorders
4/3312%
showing the 12 most frequent of 42 reported event types

Effect of Stimulant Drugs on Social Perception

NCT03790618Phase 136 enrolledUniversity of ChicagoResults posted Jan 2024

Observation window: period of time was until completion which was six weeks on average.

Study summary · from ClinicalTrials.gov

The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.

Adverse event
Placebo
n = 9
Low Dose MDMA
n = 9
High Dose MDMA
n = 9
Methamphetamine
n = 9
Overall
Serious adverse events
0/90%
0/90%
0/90%
0/90%
Any non-serious event
0/90%
0/90%
0/90%
0/90%
Deaths
0/90%
0/90%
0/90%
0/90%

Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD

NCT01793610Phase 229 enrolledResilient PharmaceuticalsResults posted Oct 2020

Observation window: All AEs from baseline to long-term follow-up (approximately 18 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main questions it aims to answer are: * Does MDMA-assisted therapy reduce PTSD symptoms? * Is there a difference in PTSD symptoms between the 40 mg, 100 mg, and 125 mg groups? Researchers will compare two active doses (100 mg and 125 mg) of MDMA-assisted therapy versus a comparator dose of 40 mg MDMA-assisted therapy to determine if there is a reduction in PTSD symptoms. Participants will undergo three non-drug preparatory sessions, three MDMA-assisted therapy sessions and three non-drug integrative therapy sessions after each MDMA-assisted therapy session.

Adverse event
Active Dose 1 MDMA (125 mg) and Psychotherapy (Stage 1)
n = 13
Active Dose 2 MDMA (100 mg) and Psychotherapy (Stage 1)
n = 9
Comparator-dose MDMA (40 mg) and Psychotherapy (Stage 1)
n = 6
Open-Label Session: Active Dose 1
n = 12
Open-Label Session: Active Dose 2
n = 9
Crossover Open-Label Sessions: Comparator Dose
n = 5
12 Month Follow-up: Active Dose 1
n = 11
12 Month Follow-up: Active Dose 2
n = 9
12 Month Follow-up: Comparator Dose
n = 5
SRRs: Active Dose 1
n = 13
SRRs: Active Dose 2
n = 9
SRRs: Comparator
n = 6
Overall
Serious adverse events
0/130%
1/911%
0/60%
0/120%
1/911%
0/50%
0/110%
1/911%
0/50%
0/130%
0/90%
0/60%
Any non-serious event
8/1362%
6/967%
1/617%
5/1242%
3/933%
3/560%
2/1118%
1/911%
1/520%
0/130%
0/90%
5/683%
Deaths
0/130%
0/90%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/130%
0/90%
0/60%
Most frequent serious events
Ruptured ovarian cyst
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
0/130%
0/90%
0/60%
0/120%
0/90%
0/50%
0/110%
1/911%
0/50%
–––
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
0/130%
0/90%
0/60%
0/120%
1/911%
0/50%
0/110%
0/90%
0/50%
–––
Tibia fracture
Injury, poisoning and procedural complications
0/130%
1/911%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
–––
Other events
Anxiety
Psychiatric disorders
3/1323%
3/933%
0/60%
0/120%
1/911%
0/50%
1/119%
0/90%
1/520%
0/120%
0/90%
5/5100%
Vomiting
Gastrointestinal disorders
3/1323%
0/90%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/130%
0/90%
0/60%
Insomnia
General disorders
0/130%
0/90%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/120%
0/90%
3/560%
Headache
General disorders
0/130%
1/911%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/120%
0/90%
2/540%
Irritability
Psychiatric disorders
1/138%
2/922%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/130%
0/90%
0/60%
Myalgia
Musculoskeletal and connective tissue disorders
0/130%
0/90%
0/60%
2/1217%
0/90%
0/50%
0/110%
0/90%
0/50%
0/130%
0/90%
0/60%
Difficulty Concentrating
General disorders
0/130%
0/90%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/120%
0/90%
2/540%
Fatigue
General disorders
0/130%
0/90%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/120%
0/90%
2/540%
Jaw Clenching, Tight Jaw
General disorders
0/130%
0/90%
0/60%
0/120%
0/90%
0/50%
0/110%
0/90%
0/50%
0/120%
0/90%
2/540%
showing the 12 most frequent of 45 reported event types

Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder

NCT01211405Phase 226 enrolledResilient PharmaceuticalsResults posted Feb 2022

Observation window: During entire study duration (approx 12 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms? Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which dose best reduces PTSD symptoms. Participants will undergo three preparatory non-drug therapy sessions with a male and female co-therapist team, then undergo three day-long MDMA-assisted therapy sessions after receiving an initial dose of 30, 75, or 125 mg MDMA HCl. After each MDMA-assisted therapy session, participants will undergo three integrative therapy sessions.

Adverse event
Blinded Low Dose MDMA-assisted Therapy
n = 7
Blinded Medium Dose MDMA-assisted Therapy
n = 7
Blinded Full Dose MDMA-assisted Therapy
n = 12
Open-Label Low Dose MDMA-assisted Therapy
n = 6
Open-Label Medium Dose MDMA-assisted Therapy
n = 6
Open-Label Full Dose MDMA-assisted Therapy
n = 12
Low Dose Group 12 Month Follow-Up
n = 6
Medium Dose Group 12 Month Follow-Up
n = 7
Full Dose Group 12 Month Follow-Up
n = 11
SRRS: Low Dose
n = 7
SRRs: Medium Dose
n = 7
SRRs: Full Dose
n = 12
Overall
Serious adverse events
1/714%
0/70%
0/120%
1/617%
0/60%
0/120%
1/617%
1/714%
0/110%
0/70%
0/70%
0/120%
Any non-serious event
6/786%
4/757%
8/1267%
6/6100%
4/667%
4/1233%
0/60%
0/70%
0/110%
7/7100%
7/7100%
12/12100%
Deaths
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
0/70%
0/70%
0/120%
Most frequent serious events
Suicidal Ideation
Psychiatric disorders
1/714%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
–––
Major Depression
Psychiatric disorders
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
1/617%
0/70%
0/110%
–––
Ventricular extrasystoles
Cardiac disorders
0/70%
0/70%
0/120%
1/617%
0/60%
0/120%
0/60%
0/70%
0/110%
–––
Appendicitis
Infections and infestations
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
1/714%
0/110%
–––
Other events
Fatigue
General disorders
2/729%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
6/786%
7/7100%
10/1283%
Anxiety
Nervous system disorders
1/714%
0/70%
1/128%
2/633%
0/60%
0/120%
0/60%
0/70%
0/110%
4/757%
5/771%
10/1283%
Insomnia
Nervous system disorders
0/70%
0/70%
1/128%
0/60%
0/60%
1/128%
0/60%
0/70%
0/110%
5/771%
3/743%
10/1283%
Need More Sleep
General disorders
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
6/786%
6/786%
9/1275%
Headache
General disorders
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
2/729%
3/743%
7/1258%
Muscle Tension
General disorders
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
2/729%
3/743%
7/1258%
Increased Irritability
General disorders
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
4/757%
2/729%
6/1250%
Lack of Appetite
General disorders
0/70%
0/70%
0/120%
0/60%
0/60%
0/120%
0/60%
0/70%
0/110%
2/729%
1/714%
6/1250%
showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD

NCT04784143Phase 226 enrolledResilient PharmaceuticalsResults posted Jul 2025

Observation window: During the Treatment Period from the first Experimental Session to the Termination visit (2-session group: approximately 13 weeks, 3-session group: approximately 16 weeks)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is effective in U.S. military veterans with at least moderate chronic PTSD. The main question it aims to answer is: Are two versus three MDMA-assisted therapy sessions in an outpatient treatment clinic more effective? Researchers will compare two MDMA-assisted therapy sessions to three MDMA-assisted therapy sessions. Participants will undergo three non-drug preparatory sessions prior to their first MDMA-assisted therapy session. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.

Adverse event
Two Sessions of MDMA-assisted Therapy
n = 13
Three Sessions of MDMA-assisted Therapy
n = 10
Overall
Serious adverse events
0/130%
0/100%
Any non-serious event
13/13100%
10/10100%
Deaths
0/130%
0/100%
Most frequent events
Insomnia
Psychiatric disorders
10/1377%
5/1050%
Headache
Nervous system disorders
5/1338%
8/1080%
Bruxism
Psychiatric disorders
7/1354%
4/1040%
Muscle tightness
Musculoskeletal and connective tissue disorders
7/1354%
6/1060%
Feeling of relaxation
General disorders
2/1315%
5/1050%
Feeling hot
General disorders
1/138%
5/1050%
Dry mouth
Gastrointestinal disorders
3/1323%
5/1050%
Nausea
Gastrointestinal disorders
3/1323%
5/1050%
Mydriasis
Eye disorders
3/1323%
5/1050%
Decreased appetite
Metabolism and nutrition disorders
5/1338%
1/1010%
Blood pressure increased
Investigations
4/1331%
4/1040%
Depressed mood
Product Issues
2/1315%
3/1030%
showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

NCT00090064Phase 223 enrolledResilient PharmaceuticalsResults posted Oct 2021

Observation window: On or after first day of study intervention through to follow-up visit (approximately 7 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy? Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions. The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period.

Adverse event
MDMA-assisted Therapy
n = 15
Placebo With Therapy
n = 8
SRRs: MDMA-assisted Therapy
n = 15
SRRs: Placebo With Therapy
n = 8
Overall
Serious adverse events
2/1513%
0/80%
0/150%
0/80%
Any non-serious event
13/1587%
8/8100%
15/15100%
8/8100%
Deaths
0/150%
0/80%
0/150%
0/80%
Most frequent serious events
Clavicle fracture
Musculoskeletal and connective tissue disorders
1/157%
0/80%
––
Syncope
Nervous system disorders
1/157%
0/80%
––
Other events
Anxiety
Psychiatric disorders
2/1513%
4/850%
14/14100%
8/8100%
Fatigue
General disorders
4/1527%
2/825%
14/1593%
8/8100%
Fatigue
General disorders
0/150%
0/80%
14/1593%
8/8100%
Headache
Nervous system disorders
1/157%
0/80%
13/1493%
8/8100%
Insomnia
Psychiatric disorders
0/150%
1/813%
12/1392%
8/8100%
Jaw clenching, tight jaw
General disorders
0/150%
0/80%
12/1486%
6/875%
Nausea
Gastrointestinal disorders
1/157%
0/80%
11/1573%
6/786%
Nausea
General disorders
0/150%
0/80%
11/1573%
6/786%
Lack of appetite
General disorders
0/150%
0/80%
10/1471%
6/875%
Sensitivity to cold
General disorders
0/150%
0/80%
10/1471%
6/875%
showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

Effects of Drugs on Responses to Brain and Emotional Processes

NCT04053036EARLY_Phase 122 enrolledUniversity of ChicagoResults posted Nov 2024

Observation window: .Through study completion, an average of 6 weeks.

Study summary · from ClinicalTrials.gov

To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits

Adverse event
Placebo
n = 22
MDMA
n = 22
Overall
Serious adverse events
0/220%
0/220%
Any non-serious event
0/220%
0/220%
Deaths
0/220%
0/220%

Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study

NCT04030169Phase 221 enrolledMAPS Europe B.V.Results posted Jan 2025

Observation window: Approximately 8 weeks

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD. The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by two sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Adverse event
Experimental: MDMA-assisted Psychotherapy
n = 21
Overall
Serious adverse events
2/2110%
Any non-serious event
21/21100%
Deaths
0/210%
Most frequent serious events
Suicidal ideation
Psychiatric disorders
1/215%
Suicidal behavior
Psychiatric disorders
1/215%
Other events
Headache
Nervous system disorders
15/2171%
Nausea
Gastrointestinal disorders
8/2138%
Muscle tightness
Musculoskeletal and connective tissue disorders
8/2138%
Suicidal ideation
Psychiatric disorders
7/2133%
Fatigue
General disorders
4/2119%
Decreased appetite
Metabolism and nutrition disorders
4/2119%
Insomnia
Psychiatric disorders
4/2119%
Myalgia
Musculoskeletal and connective tissue disorders
3/2114%
Anxiety
Psychiatric disorders
3/2114%
Palpitations
Cardiac disorders
2/2110%
showing the 12 most frequent of 23 reported event types

MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

NCT02427568Phase 218 enrolledResilient PharmaceuticalsResults posted Aug 2021

Observation window: Adverse events were collected throughout the study: up to 2 months after the 2nd experimental session (for Stage 1 blinded for placebo group), at the end of Stage 1 (for MDMA group), up to 2 months after the 3rd experimental session (for Stage 2 crossover group), and at 12-month study follow-up (approximately 1 year following the 3rd MDMA session [following Stage 1 for participants in the MDMA arm and following crossover to Stage 2 for the Stage 1 placebo group] .

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy? Researchers will compare people receiving placebo with therapy to people receiving MDMA-assisted therapy. * Participants will undergo three non-drug preparatory therapy sessions before their first blinded session of MDMA or placebo with therapy. * Each medication session will be followed by three non-drug integrative therapy sessions. * After the second blinded medication session, participants receiving MDMA will complete a third open-label medication session. * Participants who received placebo will be given the option to crossover and receive three sessions of assisted therapy.

Adverse event
Placebo With Therapy (Blinded)
n = 5
MDMA-assisted Therapy (125 mg) (Blinded)
n = 13
Placebo Group Open-label Crossover to Unblinded MDMA-assisted Therapy (125 mg)
n = 5
MDMA Group Open-label MDMA-assisted Therapy (125 mg)
n = 13
Placebo With Therapy Group 12-month Follow-up
n = 5
MDMA-assisted Therapy Group 12-month Follow-up
n = 13
Overall
Serious adverse events
0/50%
0/130%
0/50%
0/130%
0/50%
3/1323%
Any non-serious event
2/540%
11/1385%
4/580%
3/1323%
2/540%
3/1323%
Deaths
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Most frequent serious events
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Cerebrovascular accident
Nervous system disorders
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Spinal cord paralysis
Nervous system disorders
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Chordoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Meningitis
Infections and infestations
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Sepsis
Infections and infestations
0/50%
0/130%
0/50%
0/130%
0/50%
1/138%
Other events
Insomnia
Psychiatric disorders
1/520%
4/1331%
2/540%
2/1315%
1/520%
0/130%
Fatigue
General disorders
0/50%
3/1323%
0/50%
0/130%
0/50%
0/130%
Back Pain
Musculoskeletal and connective tissue disorders
0/50%
2/1315%
0/50%
0/130%
0/50%
0/130%
Contusion
Injury, poisoning and procedural complications
0/50%
2/1315%
0/50%
0/130%
0/50%
0/130%
Influenza
Infections and infestations
0/50%
2/1315%
0/50%
0/130%
0/50%
0/130%
showing the 12 most frequent of 50 reported event types· longer non-serious list truncated; totals complete

Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder

NCT00353938Phase 214 enrolledResilient PharmaceuticalsResults posted Sep 2021

Observation window: From baseline to end of Stage 3 (approximately 1 year)

Study summary · from ClinicalTrials.gov

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

Adverse event
Full Dose MDMA-assisted Therapy (125 mg Stage 1)
n = 9
Active Placebo MDMA-assisted Therapy (25 mg Stage 1)
n = 5
Full Dose MDMA-assisted Therapy (125 mg Stage 2)
n = 4
Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
n = 3
Overall
Serious adverse events
2/922%
0/50%
0/40%
0/30%
Any non-serious event
8/989%
3/560%
2/450%
1/333%
Deaths
0/90%
0/50%
0/40%
0/30%
Most frequent serious events
Metasteses to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1/911%
0/50%
0/40%
0/30%
Suicidal behavior
Psychiatric disorders
1/911%
0/50%
0/40%
0/30%
Other events
Anxiety
Psychiatric disorders
4/944%
1/520%
0/40%
0/30%
Depressed mood
Psychiatric disorders
2/922%
0/50%
0/40%
0/30%
Disturbance in attention
Psychiatric disorders
2/922%
0/50%
0/40%
0/30%
Fatigue
General disorders
1/911%
2/540%
1/425%
1/333%
Insomnia
Psychiatric disorders
2/922%
1/520%
1/425%
0/30%
Panic attack
Psychiatric disorders
1/911%
0/50%
0/40%
0/30%
Red blood cell sedimentation rate increased
Investigations
1/911%
0/50%
0/40%
0/30%
Abdominal Pain
Gastrointestinal disorders
1/911%
0/50%
0/40%
0/30%
Decreased appetite
Metabolism and nutrition disorders
1/911%
0/50%
0/40%
0/30%
Diarrhea
Gastrointestinal disorders
1/911%
0/50%
0/40%
0/30%
showing the 12 most frequent of 37 reported event types

Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

NCT02008396Phase 212 enrolledResilient PharmaceuticalsResults posted Oct 2020

Observation window: All AEs from baseline to the end of stage 2 (approximately 10 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing social anxiety in adults with autism. The main questions it aims to answer are: * Do two sessions of MDMA-assisted therapy reduce social anxiety? * What dose of MDMA is most effective at reducing social anxiety? Researchers will compare two blinded sessions of MDMA-assisted therapy to two blinded sessions of placebo with therapy. Participants will undergo three non-drug preparatory therapy sessions before the first blinded medication session. After each medication session, participants will undergo three non-drug integrative therapy sessions. In Stage 2, participants who received placebo with therapy in the first two blinded sessions will be able to undergo two sessions with MDMA-assisted therapy.

Adverse event
Group 1: MDMA-assisted Therapy 75mg/100mg
n = 4
Group 2: MDMA-assisted Therapy 100mg/125mg
n = 4
Inactive Placebo With Psychotherapy (Stage 1)
n = 4
Overall
Serious adverse events
0/40%
0/40%
0/40%
Any non-serious event
1/425%
4/4100%
1/425%
Deaths
0/40%
0/40%
0/40%
Most frequent events
Depressed mood
Psychiatric disorders
0/40%
2/450%
0/40%
Anxiety
Psychiatric disorders
0/40%
1/425%
0/40%
Irritable bowel syndrome
Gastrointestinal disorders
0/40%
0/40%
1/425%
Sinusitis
Infections and infestations
0/40%
0/40%
1/425%
Upper respiratory tract infection
Infections and infestations
0/40%
1/425%
1/425%
Depression
Psychiatric disorders
1/425%
0/40%
1/425%
Suicidal ideation
Psychiatric disorders
1/425%
1/425%
1/425%
Pain
General disorders
0/40%
1/425%
0/40%
Pyrexia
General disorders
0/40%
1/425%
0/40%
Nasopharyngitis
Infections and infestations
0/40%
1/425%
0/40%
Ligament injury
Injury, poisoning and procedural complications
0/40%
1/425%
0/40%
Retinal injury
Injury, poisoning and procedural complications
0/40%
1/425%
0/40%
showing the 12 most frequent of 18 reported event types

MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD

NCT02876172Phase 1/Phase 212 enrolledResilient PharmaceuticalsResults posted Jul 2021

Observation window: Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners. The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD? Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.

Adverse event
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
n = 6
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
n = 6
PTSD Patients at 6-month Follow-up
n = 6
CSO Patients at 6-month Follow-up
n = 6
Overall
Serious adverse events
0/60%
0/60%
0/60%
0/60%
Any non-serious event
6/6100%
6/6100%
2/633%
2/633%
Deaths
0/60%
0/60%
0/60%
0/60%
Most frequent events
Nausea
Gastrointestinal disorders
2/633%
0/60%
0/60%
0/60%
Fatigue
General disorders
2/633%
0/60%
0/60%
0/60%
Upper respiratory tract infection
Infections and infestations
2/633%
1/617%
0/60%
0/60%
Decreased appetite
Metabolism and nutrition disorders
2/633%
0/60%
0/60%
0/60%
Tinnitus
Ear and labyrinth disorders
1/617%
0/60%
0/60%
0/60%
Visual Impairment
Eye disorders
0/60%
1/617%
0/60%
0/60%
Hypothyroidism
Endocrine disorders
0/60%
0/60%
1/617%
0/60%
Vomiting
Gastrointestinal disorders
0/60%
1/617%
0/60%
0/60%
Asthenia
General disorders
1/617%
0/60%
0/60%
0/60%
Acute sinusitis
Infections and infestations
0/60%
0/60%
1/617%
0/60%
Nasopharyngitis
Infections and infestations
1/617%
0/60%
0/60%
0/60%
Arthropod bite
Injury, poisoning and procedural complications
0/60%
1/617%
0/60%
0/60%
showing the 12 most frequent of 30 reported event types

Randomized, Double-blind, Placebo-Controlled Pilot Study of MDMA-assisted Therapy for PTSD

NCT01689740Phase 210 enrolledResilient PharmaceuticalsResults posted Oct 2020

Observation window: From baseline to study completion (approximately 18 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main question it aims to answer is: Is there a reduction in PTSD symptoms in people given a low dose of MDMA with therapy versus a high dose of MDMA with therapy? Researchers will compare two sessions of MDMA-assisted therapy with either 25 mg of MDMA HCl or 125 mg of MDMA HCl in Stage 1. Participants will undergo preparatory therapy sessions without any study drug, followed by two sessions of MDMA-assisted therapy, each followed by integrative therapy sessions without study drug. Participants who received 25 mg during Stage 1 will be given the option to enroll in Stage 2 and complete two additional open-label MDMA-assisted therapy sessions with the full dose of 125 mg MDMA.

Adverse event
Lead In Open-Label: 125 mg MDMA-assisted Therapy
n = 2
Blinded Full Dose MDMA-assisted Therapy (125 mg) (Stage 1)
n = 5
Blinded Active Placebo MDMA-assisted Therapy (Stage 1)
n = 3
Open-Label Full Dose MDMA-assisted Therapy (125 mg) (Stage 2)
n = 2
12 Month Follow-Up: Open-Label Full Dose Lead-In
n = 2
12 Month Follow-Up: Blinded Full Dose
n = 5
12 Month Follow-Up: Active Placebo Dose
n = 2
SRRs: Full Dose
n = 5
SRRs: Active Placebo
n = 3
Overall
Serious adverse events
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/20%
0/50%
0/30%
Any non-serious event
2/2100%
4/580%
1/333%
2/2100%
0/20%
1/520%
0/30%
5/5100%
3/3100%
Deaths
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/20%
0/50%
0/30%
Most frequent events
Anxiety
Psychiatric disorders
1/250%
4/580%
0/30%
0/20%
0/20%
0/50%
0/30%
5/5100%
1/333%
Insomnia
Psychiatric disorders
1/250%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
5/5100%
1/333%
Fatigue
General disorders
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
5/5100%
2/367%
Headache
Nervous system disorders
0/20%
1/520%
0/30%
0/20%
0/20%
0/50%
0/30%
4/580%
0/30%
Low mood
General disorders
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
3/560%
2/367%
Need more sleep
General disorders
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
3/560%
1/333%
Restlessness
General disorders
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
3/560%
2/367%
Nausea
Gastrointestinal disorders
0/20%
1/520%
0/30%
0/20%
0/20%
0/50%
0/30%
2/540%
0/30%
Dizziness
Nervous system disorders
0/20%
2/540%
0/30%
0/20%
0/20%
0/50%
0/30%
2/540%
0/30%
Increased irritability
General disorders
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
2/540%
1/333%
Jaw Clenching, Tight Jaw
General disorders
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
2/540%
0/30%
Muscle tension
General disorders
0/20%
0/50%
0/30%
0/20%
0/20%
0/50%
0/30%
2/540%
2/367%
showing the 12 most frequent of 32 reported event types

Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

NCT01958593Phase 26 enrolledResilient PharmaceuticalsResults posted Aug 2021

Observation window: All AEs from baseline to the end of Stage 2 (approximately 10 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to compare full dose MDMA-assisted therapy to placebo with therapy in participants with chronic, treatment-resistant PTSD. The main question it aims to answer is: Does MDMA-assisted therapy versus placebo with therapy reduce PTSD symptoms? Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory therapy sessions and non-drug integration sessions. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period. Safety measures will also be assessed between groups.

Adverse event
Placebo With Therapy (Stage 1)
n = 2
MDMA-assisted Therapy (Stage 1)
n = 4
Placebo With Therapy (Stage 2)
n = 2
SRRs: Placebo With Therapy
n = 2
SRRs: MDMA-assisted Therapy
n = 4
Overall
Serious adverse events
0/20%
0/40%
0/20%
0/20%
0/40%
Any non-serious event
2/2100%
4/4100%
2/2100%
2/2100%
4/4100%
Deaths
0/20%
0/40%
0/20%
0/20%
0/40%
Most frequent events
Fatigue
General disorders
0/20%
1/425%
0/20%
2/2100%
4/4100%
Headache
Nervous system disorders
0/20%
1/425%
0/20%
2/2100%
4/4100%
Anxiety
Psychiatric disorders
0/20%
2/450%
0/20%
2/2100%
4/4100%
Insomnia
Psychiatric disorders
0/20%
1/425%
0/20%
2/2100%
4/4100%
Nausea
Gastrointestinal disorders
0/20%
1/425%
0/20%
1/250%
3/475%
Difficulty Concentrating
General disorders
0/20%
0/40%
0/20%
2/2100%
3/475%
Low mood
General disorders
0/20%
0/40%
0/20%
2/2100%
3/475%
Muscle Tension
General disorders
0/20%
0/40%
0/20%
2/2100%
3/475%
Need More Sleep
General disorders
0/20%
0/40%
0/20%
2/2100%
3/475%
Ruminations
General disorders
0/20%
0/40%
0/20%
1/250%
3/475%
Depressed Mood
Psychiatric disorders
0/20%
2/450%
0/20%
0/20%
0/40%
Diarrhea
General disorders
0/20%
0/40%
0/20%
0/20%
2/450%
showing the 12 most frequent of 30 reported event types

Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel

NCT00402298Phase 25 enrolledResilient PharmaceuticalsResults posted Sep 2021

Observation window: From informed consent to study termination after 12 month follow up

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo) MDMA-assisted therapy to determine if MDMA-assisted therapy is safe and works to treat PTSD symptoms. Participants will be randomly assigned to receive either the full dose of MDMA or low active placebo dose of MDMA during each of two experimental sessions. PTSD symptoms will be measured throughout the study.

Adverse event
Full Dose (125 mg) MDMA-assisted Therapy
n = 3
Low Dose (25 mg) MDMA-assisted Therapy
n = 2
Overall
Serious adverse events
0/30%
0/20%
Any non-serious event
2/367%
2/2100%
Deaths
0/30%
0/20%
Most frequent events
Fasciculation
Musculoskeletal and connective tissue disorders
1/333%
1/250%
Vomiting
Gastrointestinal disorders
1/333%
0/20%
Flatulence
Gastrointestinal disorders
1/333%
0/20%
Viral upper respiratory tract infection
Respiratory, thoracic and mediastinal disorders
0/30%
1/250%
Myoclonus
Musculoskeletal and connective tissue disorders
0/30%
1/250%

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

NCT03485287Phase 24 enrolledResilient PharmaceuticalsResults posted Jul 2021

Observation window: Treatment-emergent adverse events through study completion (approximately 5 months)

Study summary · from ClinicalTrials.gov

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with at least severe PTSD. The main question it aims to answer is: Do three open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by three sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Adverse event
MDMA-assisted Therapy (100 to 125 mg)
n = 4
Overall
Serious adverse events
0/40%
Any non-serious event
4/4100%
Deaths
0/40%
Most frequent events
Headache
Nervous system disorders
3/475%
Anxiety
Psychiatric disorders
3/475%
Palpitations
Cardiac disorders
2/450%
Nausea
Gastrointestinal disorders
2/450%
Fatigue
General disorders
2/450%
Dizziness
Nervous system disorders
2/450%
Syncope
Nervous system disorders
2/450%
Insomnia
Psychiatric disorders
2/450%
Nightmare
Psychiatric disorders
2/450%
Diarrhea
Gastrointestinal disorders
1/425%
Aphthous ulcer
Gastrointestinal disorders
1/425%
Vomiting
Gastrointestinal disorders
1/425%
showing the 12 most frequent of 29 reported event types

Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

NCT01458327Phase 23 enrolledResilient PharmaceuticalsResults posted Nov 2021

Observation window: Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.

Study summary · from ClinicalTrials.gov

This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.

Adverse event
3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy
n = 3
Overall
Serious adverse events
1/333%
Any non-serious event
1/333%
Deaths
0/30%
Most frequent serious events
Suicidal ideation
Psychiatric disorders
1/333%
Other events
Major depression
Psychiatric disorders
1/333%
Drug abuse
Psychiatric disorders
1/333%
Dissociation
Psychiatric disorders
1/333%
Upper respiratory tract infection
Infections and infestations
1/333%

MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer

NCT00252174Phase 22 enrolledBrigham and Women's HospitalResults posted May 2017
Study summary · from ClinicalTrials.gov

This is a pilot study intended to find out if 3,4-methylenedioxymethamphetamine (MDMA) is safe and can help people with advanced stage cancer and anxiety arising from the cancer diagnosis.

Adverse event
Stage 1, Active
n = 0
Stage 1, Control
n = 2
Stage 2, Active
n = 0
Overall
Serious adverse events–
0/20%
–
Any non-serious event–
0/20%
–
Deaths–
0/20%
–

Not a regulatory or clinical tool, and no medical advice. Not affiliated with any sponsor, regulator, or any organization whose trials appear here.