Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (MPG1)
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|ClinicalTrials.gov Identifier: NCT05173831|
Recruitment Status : Not yet recruiting
First Posted : December 30, 2021
Last Update Posted : August 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Drug: MDMA Behavioral: Therapy||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 effects of two sessions of MDMA-assisted therapy followed by four integrative sessions after each of the two MDMA sessions|
|Masking:||None (Open Label)|
|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 :||September 2022|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Two MDMA-assisted Therapy Sessions
Two Experimental MDMA-assisted Therapy Sessions, and four Integrative Sessions following each Experimental Sessions.
Initial dose of 120 mg MDMA HCL and optional supplemental dose of 40 or 60 mg MDMA HCL at 1.5 to 2 hours after first dose
Other Name: 3,4-methylenedioxymethamphetamine
Standardized non-directive psychotherapy performed by therapist team
- Change in CAPS-5 Total Severity Score from Baseline to Visit 16 [ Time Frame: Baseline - 3 months from enrollment ]The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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. The dichotomous diagnostic score is based upon meeting each of five criteria, including index trauma, presence or absence of Criteria B, C, D described above, duration of symptoms and distress and is scored as meeting versus not meeting criteria for diagnosis.
- Change in Sheehan Disability Scale (SDS) from Baseline to Visit 16 [ Time Frame: Baseline - 3 months from enrollment ]Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The 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).
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): NCT05173831
|Contact: Philip Bouleh||503-329-4980||Philip.Bouleh@va.gov|