A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD (MAPPUSX)
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ClinicalTrials.gov Identifier: NCT04714359 |
Recruitment Status :
Completed
First Posted : January 19, 2021
Last Update Posted : April 29, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | January 14, 2021 | ||||||||||||||
First Posted Date ICMJE | January 19, 2021 | ||||||||||||||
Last Update Posted Date | April 29, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | March 8, 2021 | ||||||||||||||
Actual Primary Completion Date | November 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Change from Baseline to Visit 16 in PCL-5 total score [ Time Frame: Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3) ] The PCL-5 is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. Participants indicate how much distress they have experienced in the last 2 weeks due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" on a five-point Likert-type scale (1=Not at all to 5=Extremely), with lower scores indicating less PTSD symptoms.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
Change from Baseline to Visit 16 in Sheehan Disability Scale (SDS) total score [ Time Frame: Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3) ] The SDS is a self-report assessment of functional impairment. The reporting period for the SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD | ||||||||||||||
Official Title ICMJE | A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder | ||||||||||||||
Brief Summary | This multi-site open-label study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were enrolled in a parent study for treatment of posttraumatic stress disorder (PTSD). The study will be conducted in up to N ≈ 100 participants. Participants will receive a flexible dose of MDMA, followed by a supplemental dose, unless contraindicated, during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is the change in PTSD Checklist (PCL-5) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) from Visit 3 is assessed at Visit 16. This study will compare the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg. | ||||||||||||||
Detailed Description | PTSD is a serious debilitating disorder that negatively impacts a person's daily life. PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war, disaster, sexual abuse, violence, terrorism, and accidents. PTSD negatively impacts a person's daily life, resulting in relationship difficulties, difficulty in finding and maintaining a job, reduced cognitive and psychosocial functioning, substance abuse, high-cost healthcare use, and increased depression and suicide risk. Available PTSD treatments, including medications and therapy, effectively treat only a fraction of people who try them for adequate dose and duration. People with PTSD can be treated with psychotherapies and pharmacotherapies. In the past decade, there has been a growing amount of research into medications and other methods that may augment the effectiveness of psychotherapy for PTSD 3,4-methylenedioxymethamphetamine (MDMA) is a drug that releases serotonin, norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin, arginine vasopressin and cortisol. The combined neurobiological effects of MDMA increase compassion, reduce defenses and fear of emotional injury, and enhance communication and introspection. MDMA produces anxiolytic and prosocial effects, which counteract avoidance and hyperarousal in the context of therapy. A combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD. This multi-site, open-label safety extension study assesses the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy in participants diagnosed with PTSD. The study will be conducted in N ≈ 100 participants. Participants who were randomized to the placebo arm in the two parent Phase 3 trials of MDMA-assisted psychotherapy and who meet all other entry criteria will be eligible and invited to participate in this open-label safety extension study. In addition, participants in the parent Phase 3 trials whose study participation was affected by COVID-19 pandemic or other unforeseen circumstances, and were unable to complete the study may participate in this open-label study. The treatment consists of a flexible dose of MDMA (80 or 120 mg), followed by a supplemental dose (40 or 60 mg) unless contraindicated, administered with manualized psychotherapy in three open-label approximately monthly Experimental Sessions. During Experimental Session 1, participants will receive an initial dose of 80 mg of MDMA, followed by a supplemental dose of 40 mg. During Experimental Sessions 2 and 3, participants will receive an initial dose of 80 or 120 mg of MDMA, followed by a supplemental dose of 40 or 60 mg. This Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. Experimental Sessions are followed by an overnight stay. The Primary Outcome measure, the change in PCL-5 (PTSD Checklist for DSM-5) from Visit 3 is assessed at Visit 16. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | PTSD | ||||||||||||||
Intervention ICMJE | Drug: Midomafetamine
Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Other Names:
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Study Arms ICMJE | Experimental: MDMA-assisted therapy
Three open-label sessions of MDMA-assisted therapy with flexible dose of MDMA (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later
Intervention: Drug: Midomafetamine
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||
Actual Enrollment ICMJE |
85 | ||||||||||||||
Original Estimated Enrollment ICMJE |
100 | ||||||||||||||
Actual Study Completion Date ICMJE | November 6, 2023 | ||||||||||||||
Actual Primary Completion Date | November 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Canada, Israel, United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04714359 | ||||||||||||||
Other Study ID Numbers ICMJE | MAPPUSX | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Lykos Therapeutics | ||||||||||||||
Original Responsible Party | Multidisciplinary Association for Psychedelic Studies | ||||||||||||||
Current Study Sponsor ICMJE | Lykos Therapeutics | ||||||||||||||
Original Study Sponsor ICMJE | Multidisciplinary Association for Psychedelic Studies | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Lykos Therapeutics | ||||||||||||||
Verification Date | April 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |