A Study to Assess the Use of Methylone in the Treatment of PTSD
NCT ID: NCT05741710
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
79 participants
INTERVENTIONAL
2023-03-01
2025-02-19
Brief Summary
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* Part A is open-label and will enroll up to 15 participants with PTSD
* Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD
Eligible participants will enter a 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Methylone
Methylone
Methylone capsules, given orally, once a week for 4 weeks
Placebo
Placebo
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B
Interventions
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Methylone
Methylone capsules, given orally, once a week for 4 weeks
Placebo
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B
Eligibility Criteria
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Inclusion Criteria
* CAPS-5 score of ≥35 at Screening.
* Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
* Proficient in reading and writing in local language sufficient to complete questionnaires.
* Free from any other clinically significant illness or disease
Exclusion Criteria
* Body mass index (BMI) \<18 kg/m2 or ≥40 kg/m2.
* Smokes an average of \>10 cigarettes and/or e-cigarettes per day
* Uncontrolled hypertension at Screening
* Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
* Use of an SSRI or other antidepressant within 8 weeks of screening.
* Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.
18 Years
65 Years
ALL
No
Sponsors
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Transcend Therapeutics
INDUSTRY
Responsible Party
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Locations
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Mountain View Clinical Research
Denver, Colorado, United States
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, United States
Accel Research Sites
Maitland, Florida, United States
Sunstone Therapies
Rockville, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Cenexel HRI
Berlin, New Jersey, United States
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
Cedar Clinical Research
Murray, Utah, United States
Tallaght Adult Mental Health Services
Dublin, , Ireland
La Nua Day Hospital Mental Health Centre
Galway, , Ireland
Mirabilis Health
Belfast, Northern Ireland, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Glasgow Clinical Research Facility, QEUH
Glasgow, , United Kingdom
Clerkenwell Health
London, , United Kingdom
King's College
London, , United Kingdom
Oxford Health NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Other Identifiers
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TT-TSND-201
Identifier Type: -
Identifier Source: org_study_id
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