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- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment closed: MDMA for Co-occurring PTSD and OUD After Childbirth (clinicaltrials.gov) - May 1, 2024
P2, N=15, Active, not recruiting, Sponsor: University of New Mexico
Not yet recruiting --> Active, not recruiting
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: Psychedelic Therapy: A Primer for Primary Care Clinicians-3,4-Methylenedioxy-methamphetamine (MDMA). (Pubmed Central) - Mar 26, 2024
Phase III trials suggest that MDMA is superior to antidepressant medications for treating PTSD. Now that MAPS has officially requested the Food and Drug Administration to approve MDMA as a treatment for PTSD, legal MDMA-assisted therapy may become available as soon as 2024.
- || midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Clinical, Journal: Effects of MDMA-assisted therapy for PTSD on self-experience. (Pubmed Central) - Jan 14, 2024
P3
Compared with Therapy with placebo, MDMA-assisted therapy had significant positive effects on transdiagnostic mental processes of self-experience which are often associated with poor treatment outcome. This provides a possible window into understanding the psychological capacities facilitated by psychedelic agents that may result in significant improvements in PTSD symptomatology.
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion, Trial completion date, Trial primary completion date: MAPPUSX: A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD (clinicaltrials.gov) - Dec 7, 2023
P3, N=85, Completed, Sponsor: Multidisciplinary Association for Psychedelic Studies
This provides a possible window into understanding the psychological capacities facilitated by psychedelic agents that may result in significant improvements in PTSD symptomatology. Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Nov 2023 | Trial primary completion date: Oct 2024 --> Nov 2023
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment closed, Trial completion date, Trial primary completion date: MAPPUSX: A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD (clinicaltrials.gov) - Sep 21, 2023
P3, N=100, Active, not recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Nov 2023 | Trial primary completion date: Oct 2024 --> Nov 2023 Enrolling by invitation --> Active, not recruiting | Trial completion date: Aug 2023 --> Oct 2024 | Trial primary completion date: Aug 2023 --> Oct 2024
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
New P2 trial: MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders (EUDRACT) - Sep 13, 2023
P2, N=24, Not yet recruiting, Sponsor: Monash University
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment status, Trial completion date, Trial primary completion date: Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study (clinicaltrials.gov) - Sep 5, 2023
P2, N=40, Enrolling by invitation, Sponsor: MAPS Europe B.V.
Enrolling by invitation --> Active, not recruiting | Trial completion date: Aug 2023 --> Oct 2024 | Trial primary completion date: Aug 2023 --> Oct 2024 Recruiting --> Enrolling by invitation | Trial completion date: Nov 2022 --> Dec 2023 | Trial primary completion date: Nov 2022 --> Dec 2023
- midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion date, Trial primary completion date: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) (clinicaltrials.gov) - Jul 7, 2023
P2, N=10, Active, not recruiting, Sponsor: Remedy
Recruiting --> Enrolling by invitation | Trial completion date: Nov 2022 --> Dec 2023 | Trial primary completion date: Nov 2022 --> Dec 2023 Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
- || midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Review, Journal: Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. (Pubmed Central) - Jul 5, 2023
BTD status has expedited the development of MAPS phase 3 trials occurring worldwide, leading up to a planned submission seeking FDA approval in 2021. Appeared originally in Front Psychiatry 2019; 10:650.
- ||| midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Clinical, P3 data, Journal: MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. (Pubmed Central) - Jul 5, 2023
P3
We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. Appeared originally in Nat Med 2021; 27:1025-1033.
- | Trial completion date: Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2) (clinicaltrials.gov) - Feb 13, 2023
P1, N=150, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Appeared originally in Nat Med 2021; 27:1025-1033. Trial completion date: Dec 2026 --> Dec 2025
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder. (Pubmed Central) - Jan 31, 2023
P=N/A
More research is necessary to determine if these findings are specific to MDMA-AT compared to other types of treatment for PTSD. https://clinicaltrials.gov/ct2/show/NCT02102802, identifier NCT02102802.
- midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment closed, Trial completion date, Trial primary completion date: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) (clinicaltrials.gov) - Jan 27, 2023
P2, N=10, Active, not recruiting, Sponsor: Remedy
https://clinicaltrials.gov/ct2/show/NCT02102802, identifier NCT02102802. Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment status: SAMATI: Social Anxiety MDMA-Assisted Therapy Investigation (clinicaltrials.gov) - Jan 23, 2023
P2, N=20, Enrolling by invitation, Sponsor: Jason B Luoma
Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023 Recruiting --> Enrolling by invitation
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion date, Trial primary completion date: MPLONG: Long-Term Safety and Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder (clinicaltrials.gov) - Jan 12, 2023
P=N/A, N=400, Enrolling by invitation, Sponsor: Multidisciplinary Association for Psychedelic Studies
Recruiting --> Enrolling by invitation Trial completion date: Mar 2025 --> Oct 2024 | Trial primary completion date: Mar 2025 --> Oct 2024
- | Trial completion date, Trial primary completion date: MED1: A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders (clinicaltrials.gov) - Jan 12, 2023
P2, N=36, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Trial completion date: Mar 2025 --> Oct 2024 | Trial primary completion date: Mar 2025 --> Oct 2024 Trial completion date: Mar 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Aug 2025
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion date, Trial primary completion date: MDMA for Co-occurring PTSD and OUD After Childbirth (clinicaltrials.gov) - Jan 10, 2023
P2, N=15, Not yet recruiting, Sponsor: University of New Mexico
Trial completion date: Mar 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Aug 2025 Trial completion date: Oct 2024 --> Nov 2025 | Trial primary completion date: May 2024 --> Apr 2025
- | Trial completion: MPKF: Food Effects on Bioavailability of MDMA in Healthy Volunteers (clinicaltrials.gov) - Jan 6, 2023
P1, N=14, Completed, Sponsor: Multidisciplinary Association for Psychedelic Studies
Trial completion date: Oct 2024 --> Nov 2025 | Trial primary completion date: May 2024 --> Apr 2025 Recruiting --> Completed
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: MDMA-assisted therapy is associated with a reduction in chronic pain among people with post-traumatic stress disorder. (Pubmed Central) - Nov 22, 2022
P2
Findings demonstrate a high prevalence of chronic pain in this sample of people with severe PTSD and that chronic pain scores among medium and high pain subgroups were significantly lower following MDMA-AT. While these data are preliminary, when considered alongside the frequency of comorbid chronic pain and PTSD and promising efficacy of MDMA-AT for treating PTSD, these findings encourage further research exploring the role of MDMA-AT for chronic pain.
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: Therapeutic setting as an essential component of psychedelic research methodology: Reporting recommendations emerging from clinical trials of 3,4-methylenedioxymethamphetamine for post-traumatic stress disorder. (Pubmed Central) - Nov 22, 2022
In fact, recommendations should be expanded to "set" - the subject's mood, expectations, and broader psychological condition - once this is more fully developed in the field. The proposed reporting guidelines offer a means of increasing the volume and variability of data necessary for future empirical examination of key setting attributes influencing treatment efficacy, while preserving practitioner and patient autonomy to co-construct adaptive therapy settings according to their respective needs and expertise.
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion, Trial completion date: A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) (clinicaltrials.gov) - Nov 9, 2022
P3, N=121, Completed, Sponsor: Multidisciplinary Association for Psychedelic Studies
The proposed reporting guidelines offer a means of increasing the volume and variability of data necessary for future empirical examination of key setting attributes influencing treatment efficacy, while preserving practitioner and patient autonomy to co-construct adaptive therapy settings according to their respective needs and expertise. Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Nov 2022
- | Trial completion date, Trial primary completion date: Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2) (clinicaltrials.gov) - Oct 25, 2022
P1, N=150, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Nov 2022 Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
- | Trial completion date, Trial primary completion date: MED1: A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders (clinicaltrials.gov) - Oct 24, 2022
P2, N=36, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Nov 2025 Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion date, Trial initiation date, Trial primary completion date: MPG1: Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (clinicaltrials.gov) - Oct 21, 2022
P2, N=18, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024 Trial completion date: Jun 2023 --> Jun 2024 | Initiation date: Oct 2022 --> Jan 2023 | Trial primary completion date: Jun 2023 --> Jun 2024
- midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Pediatric Study Plan Agreed Upon With the FDA for the Use of MDMA for PTSD in Children and Adolescents () - Oct 19, 2022 - Abstract #AACAP2022AACAP_1301;
Conclusions MDMA-assisted therapy is efficacious in treating severe, chronic PTSD in adults with a favorable safety profile and qualifies as a breakthrough-designated therapy. Pediatric studies are warranted to address anunmet medical need.
- | Trial completion: Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (clinicaltrials.gov) - Oct 13, 2022
P1, N=107, Completed, Sponsor: Multidisciplinary Association for Psychedelic Studies
Pediatric studies are warranted to address anunmet medical need. Enrolling by invitation --> Completed
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: Is psychedelic use associated with cancer?: Interrogating a half-century-old claim using contemporary population-level data. (Pubmed Central) - Oct 12, 2022
While laboratory studies and case reports from the 1960s and 1970s generated concerns about psychedelics' carcinogenic potential, this analysis of recent epidemiological data does not support an association between psychedelic use and development of cancer in general or hematologic cancer. Important study limitations to consider include a lack of information about psychedelic dosage, number of lifetime psychedelic exposures, and the temporal relationship between psychedelic use and cancer diagnosis.
- midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment open: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) (clinicaltrials.gov) - Oct 5, 2022
P2, N=10, Recruiting, Sponsor: Remedy
Important study limitations to consider include a lack of information about psychedelic dosage, number of lifetime psychedelic exposures, and the temporal relationship between psychedelic use and cancer diagnosis. Suspended --> Recruiting
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion date, Trial primary completion date: MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function (clinicaltrials.gov) - Aug 18, 2022
P1, N=16, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Suspended --> Recruiting Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- ||| midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
P2 data, P3 data, Retrospective data, Journal: MDMA-assisted therapy for posttraumatic stress disorder: A pooled analysis of ethnoracial differences in efficacy and safety from two Phase 2 open-label lead-in trials and a Phase 3 randomized, blinded placebo-controlled trial. (Pubmed Central) - Aug 10, 2022
There was also a trend toward greater efficacy with Placebo-AT among BIPOC participants. There was an imbalance in subgroups, highlighting the need for culturally responsive recruitment strategies to diversify future studies.
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial initiation date: MDMA for Co-occurring PTSD and OUD After Childbirth (clinicaltrials.gov) - Jul 29, 2022
P2, N=15, Not yet recruiting, Sponsor: University of New Mexico
There was an imbalance in subgroups, highlighting the need for culturally responsive recruitment strategies to diversify future studies. Initiation date: May 2022 --> Feb 2023
- | Enrollment open: MPKF: Food Effects on Bioavailability of MDMA in Healthy Volunteers (clinicaltrials.gov) - Jul 29, 2022
P1, N=12, Recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Initiation date: May 2022 --> Feb 2023 Not yet recruiting --> Recruiting
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment open, Trial completion date, Trial primary completion date, HEOR: MPVA6: Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD (clinicaltrials.gov) - Jul 29, 2022
P2, N=60, Recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting | Trial completion date: Aug 2022 --> Jul 2025 | Trial primary completion date: Aug 2022 --> Jul 2025
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment closed, HEOR: MPVA6: Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD (clinicaltrials.gov) - Jul 28, 2022
P2, N=60, Active, not recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Active, not recruiting --> Recruiting | Trial completion date: Aug 2022 --> Jul 2025 | Trial primary completion date: Aug 2022 --> Jul 2025 Recruiting --> Active, not recruiting
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial initiation date: MPG1: Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (clinicaltrials.gov) - Jul 7, 2022
P2, N=18, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Recruiting --> Active, not recruiting Initiation date: Jun 2022 --> Sep 2022
- midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial suspension: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) (clinicaltrials.gov) - Jun 28, 2022
P2, N=10, Suspended, Sponsor: Remedy
Initiation date: Jun 2022 --> Sep 2022 Recruiting --> Suspended
- | Trial initiation date: MPKF: Food Effects on Bioavailability of MDMA in Healthy Volunteers (clinicaltrials.gov) - May 20, 2022
P1, N=12, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Recruiting --> Suspended Initiation date: Apr 2022 --> Jul 2022
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial completion date, Trial primary completion date: MAPPUSX: A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD (clinicaltrials.gov) - May 11, 2022
P3, N=100, Enrolling by invitation, Sponsor: Multidisciplinary Association for Psychedelic Studies
Initiation date: Apr 2022 --> Jul 2022 Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment closed: A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) (clinicaltrials.gov) - May 10, 2022
P3, N=100, Active, not recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023 Recruiting --> Active, not recruiting
- ||| midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
P3 data, Journal: The effects of MDMA-assisted therapy on alcohol and substance use in a phase 3 trial for treatment of severe PTSD. (Pubmed Central) - Apr 26, 2022
MDMA-AT does not appear to increase risk of illicit drug use. These data provide preliminary evidence to support the development of MDMA-AT as an integrated treatment for co-occurring PTSD and ASUD.
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment open: SAMATI: Social Anxiety MDMA-Assisted Therapy Investigation (clinicaltrials.gov) - Apr 25, 2022
P2, N=20, Recruiting, Sponsor: Jason B Luoma
These data provide preliminary evidence to support the development of MDMA-AT as an integrated treatment for co-occurring PTSD and ASUD. Not yet recruiting --> Recruiting
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD. (Pubmed Central) - Apr 13, 2022
MDMA-AT significantly reduced ED symptoms compared to therapy with placebo among participants with severe PTSD. MDMA-AT for ED-PTSD appears promising and requires further study.
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: Three regulatory compliant test systems show no signs of MDMA-related genotoxicity. (Pubmed Central) - Feb 22, 2022
We performed three regulatory compliant studies to investigate the potential of genotoxic effects of MDMA treatment in humans: (1) an in vitro bacterial reverse mutation (Ames) assay, (2) an in vitro chromosome aberration test in Chinese hamster ovary cells, and (3) an in vivo micronucleus study in male Sprague Dawley rats. MDMA was found to not have genotoxic effects in any of the assays at or above clinically relevant concentrations.
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date: NUMCAP1: Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD (clinicaltrials.gov) - Feb 10, 2022
P2, N=0, Withdrawn, Sponsor: Multidisciplinary Association for Psychedelic Studies
MDMA was found to not have genotoxic effects in any of the assays at or above clinically relevant concentrations. N=20 --> 0 | Trial completion date: Feb 2023 --> Aug 2023 | Initiation date: May 2022 --> Aug 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2022 --> Aug 2023
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
New P2 trial: MDMA for Co-occurring PTSD and OUD After Childbirth (clinicaltrials.gov) - Jan 31, 2022
P2, N=15, Not yet recruiting, Sponsor: University of New Mexico
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Journal: Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA. (Pubmed Central) - Jan 18, 2022
The overall yield was acceptable (41-53%, over four steps), and the chemical purity of the final product was excellent, exceeding 99.9% of the peak area by HPLC in each of the four validation trials. The availability of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use, if encouraging results lead to FDA approval.
- | Trial completion date, Trial primary completion date: Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (clinicaltrials.gov) - Jan 13, 2022
P1, N=100, Enrolling by invitation, Sponsor: Multidisciplinary Association for Psychedelic Studies
The availability of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use, if encouraging results lead to FDA approval. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Aug 2022
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
Trial initiation date: NUMCAP1: Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD (clinicaltrials.gov) - Jan 6, 2022
P2, N=20, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Aug 2022 Initiation date: Dec 2021 --> May 2022
- | Trial completion date, Trial primary completion date: MED1: A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders (clinicaltrials.gov) - Jan 6, 2022
P2, N=36, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies
Initiation date: Dec 2021 --> May 2022 Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- | midomafetamine (MDMA) / Multidisciplinary Association for Psychedelic Studies (MAPS)
New P2 trial: MPG1: Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (clinicaltrials.gov) - Dec 30, 2021
P2, N=18, Not yet recruiting, Sponsor: Multidisciplinary Association for Psychedelic Studies