Status:
COMPLETED
Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
Lead Sponsor:
Lykos Therapeutics
Conditions:
PTSD
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 s...
Detailed Description
This multi-site, open-label, Phase 2, lead-in study assesses the safety and efficacy of MDMA-assisted therapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Thera...
Eligibility Criteria
Inclusion
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
- Must agree to inform the investigators within 48 hours of any medical conditions and procedures
- If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
- Must not participate in any other interventional clinical trials during the duration of the study,
- Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
- Meet DSM-5 Criteria for Severe PTSD
Exclusion
- Are not able to give adequate informed consent
- Have uncontrolled hypertension
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] corrected by Bazett's formula)
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Have evidence or history of significant medical disorders
- Have symptomatic liver disease
- Have history of hyponatremia or hyperthermia
- Weigh less than 48 kilograms (kg)
- Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
- Meet DSM-5 criteria for active substance use disorder for any substance other than caffeine or nicotine
- Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session.
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03282123
Start Date
November 16 2017
End Date
August 10 2019
Last Update
June 5 2025
Active Locations (12)
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1
New School Research LLC
North Hollywood, California, United States, 91601
2
San Francisco Insight and Integration Center
San Francisco, California, United States, 94114
3
University of California San Francisco
San Francisco, California, United States, 94122
4
Aguazul-Blue Water Inc.
Boulder, Colorado, United States, 80302