Status:
COMPLETED
A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
Lead Sponsor:
Lykos Therapeutics
Conditions:
PTSD
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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. T...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Were previously enrolled in a parent study and (meet one of the following):
- At time of unblinding, their treatment assignment was to the placebo arm; or,
- Did not begin Experimental Sessions due to the COVID-19 global pandemic or other unforeseen circumstances;
- Completed fewer than three Experimental Sessions prior to Study Termination due to the COVID-19 global pandemic or other unforeseen circumstances.
- Are considered in good standing with the study site at which they enrolled in a parent study; if, in the opinion of the investigator, therapy team, and Medical Monitor, the participant was compliant with protocol requirements, even if they were unable to complete all study visits.
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Are able to swallow pills
- 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
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions.
- 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.
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 \[ms\] in males and \>460 ms in females corrected by Fridericia 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, such as myocardial infarction, cerebrovascular accident, or aneurysm
- Have symptomatic liver disease
- Have recent 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
- Have an active illicit or prescription drug substance use disorder within 12 months
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04714359
Start Date
March 8 2021
End Date
November 6 2023
Last Update
June 6 2025
Active Locations (15)
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1
New School Research
Los Angeles, California, United States, 90004
2
San Francisco Insight and Integration Center
San Francisco, California, United States, 94114
3
UCSF
San Francisco, California, United States, 94122
4
Aguazul-Blue Water Inc.
Boulder, Colorado, United States, 80302