Protocol Objectives definition
Protocol Objectives. The overall objective of this study is to examine whether a full dose of MDMA versus a low dose of MDMA used in conjunction with manualized psychotherapy will reduce or attenuate PTSD symptoms as evaluated by standard clinical measures and to collect safety data. Primary Objective: Assess changes in PTSD symptoms in participants receiving the full dose of MDMA compared to the low dose as measured by Global CAPS scores at baseline and the primary endpoint, one month after the second experimental session. Primary Outcome Measure: Clinician-Administered PTSD scale (CAPS) administered by a blinded Independent Rater Secondary Outcome Measures: ▇▇▇▇ Depression Inventory-II (BDI-II), Global Assessment of Function (GAF), Posttraumatic Stress Diagnostic Scale (PDS), Pittsburg Sleep Quality Index (PSQI), States of Consciousness Scale (SOCQ) Safety Measures: Columbia Suicide Severity Rating Scale (C-SSRS), ▇▇▇▇▇ ▇▇▇▇▇, Subjective Units of Distress (SUD), Adverse Events and Spontaneously Reported Reactions Process Measures: Belief of condition assignment, Reactions to Research Participation Questionnaire (RRPQ), Perception of Third Session, Adherence Criteria Ratings, Short Working Alliance Inventory – Observer based (SWAI-O) Recruitment and Participant Population: Participants may be male or female, aged 18 or older, with a confirmed diagnosis of chronic PTSD, who have undergone at least one treatment of adequate dose/duration for PTSD without achieving remission. Prior treatment can include psychotherapeutic or pharmacological treatments, and people who have undergone one or more prior treatments are eligible for study participation. Participants who discontinued PTSD treatment due to inability to tolerate psychotherapy (e.g. due to persistent “over-engagement”) or psychopharmacology due to treatment-emergent side effects would not be excluded. Participants
Protocol Objectives. The overall objective of this study is to examine whether the full dose of MDMA versus the comparator dose of MDMA used in conjunction with manualized psychotherapy will reduce or attenuate PTSD symptoms as evaluated by standard clinical measures and to collect safety data.