PTSD
Conditions
Keywords
MDMA, PTSD, Veterans, Group Therapy
Brief summary
This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.
Detailed description
To assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor-investigator is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly open-label MDMA Sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Clinical Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.
Interventions
DRUGMDMA
Initial dose of 120 mg MDMA HCL and optional supplemental dose of 60 mg MDMA HCL at 1.5 to 2 hours after first dose
BEHAVIORALGroup Therapy
Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy
Sponsors
Steven & Alexandra Cohen Foundation
Portland VA Research Foundation, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Independent raters for the primary clinical outcome will be blinded to study design and timepoint.
Intervention model description
Open-label study examining safety and feasibility of MDMA-assisted group therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Are at least 18 years old. * Are a U.S. Military Veteran * 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 MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions. * Must provide a contact 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 able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session. * Must not participate in any other interventional clinical trials during the duration of the study. * Must commit to medication dosing, therapy, and study procedures. * Have a current PTSD diagnosis at the time of screening.
Exclusion criteria
* Are not able to give adequate informed consent. * Have uncontrolled hypertension. * Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments. * 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 or biliary disease. * Have history of hyponatremia or hyperthermia. * Weigh less than 48 kilograms (kg). * Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control. * Are abusing illegal drugs or alcohol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CAPS-5 Total Severity Score | Baseline - 3 months from first Experimental Session | The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sheehan Disability Scale (SDS) | Baseline - 3 months from first Experimental Session | Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The first three 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), and five verbal tags (not at all, mildly, moderately, markedly, extremely). The remaining two items assess Days Lost and Days Unproductive during the reporting period. |
Countries
United States
Outcome results
None listed