Posttraumatic Stress Disorder
Conditions
Brief summary
The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD. The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.
Detailed description
This Phase 2, open-label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants. The Preparatory Period will consist of three 90-minute non-drug preparatory therapy sessions. A flexible divided dose of MDMA will be administered during the Treatment Period with manualized therapy in up to two open-label experimental sessions. During the Treatment Period, each experimental session is followed by three 90-minute non-drug integrative therapy sessions. The experimental sessions are scheduled roughly 3 to 5 weeks apart.
Interventions
DRUGmidomafetamine
80 mg or 120 mg midomafetamine HCl followed by a 40 mg supplement dose
BEHAVIORALTherapy
Manualized therapy
Sponsors
Lykos Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are at least 18 years old. * Are fluent in speaking and reading a recognized language of the study site. * Are able to swallow pills. * Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions. * Must provide a contact (relative, spouse, close friend, or other support person) 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, and commit to medication dosing, therapy, and study procedures. * At baseline, have moderate PTSD diagnosis.
Exclusion criteria
* 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 Friderica'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. * Have current alcohol or substance use disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in PTSD Checklist (adapted PCL-5) total score | 18 weeks post baseline post enrollment confirmation | 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. The gold standard for diagnosing PTSD is a structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS-5). When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis.The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: Not at all, A little bit, Moderately, Quite a bit, and Extremely. |
Outcome results
None listed