Group MDMA-therapy for Veterans With PTSD (Group-MVP)
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|ClinicalTrials.gov Identifier: NCT05961527|
Recruitment Status : Not yet recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Drug: MDMA Behavioral: Group Therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label study examining safety and feasibility of MDMA-assisted group therapy|
|Masking:||None (Open Label)|
|Masking Description:||Independent raters for the primary clinical outcome will be blinded to study design and timepoint.|
|Official Title:||An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans|
|Estimated Study Start Date :||October 1, 2023|
|Estimated Primary Completion Date :||July 31, 2025|
|Estimated Study Completion Date :||September 30, 2025|
Experimental: MDMA-assisted group therapy
Four Preparatory Sessions, two MDMA Sessions, and four Integrative Sessions following each MDMA Session.
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
Other Name: 3,4-methylenedioxymethamphetamine
Behavioral: Group Therapy
Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy
- Change in CAPS-5 Total Severity Score [ Time Frame: 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.
- Change in Sheehan Disability Scale (SDS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961527
|Contact: Kevin Rothstein-Kightly, MS||503-450-9349||Kevin.Rothstein-Kightly@va.gov|