The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD. The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms? Participants will undergo non-drug preparatory therapy sessions before their MDMA-assisted therapy sessions. After, they will undergo non-drug integrative therapy sessions.
To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a Phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA (120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later), along with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Initial dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later
Manualized therapy performed by therapist team
Change in CAPS-5 Total Severity Score
The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure \[114\], including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score \[114\]. 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.
Time frame: Baseline - 3 months from first Experimental Session
Change in Sheehan Disability Scale (SDS)
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.
Time frame: Baseline - 3 months from First Experimental Session
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