Group-MVP: Group MDMA-therapy for Veterans With PTSD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MDMA-assisted group therapy Four Preparatory Sessions, two MDMA Sessions, and four Integrative Sessions following each MDMA Session. |
Drug: MDMA
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 Names:
Behavioral: Group Therapy
Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Are at least 18 years old.
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Are a U.S. Military Veteran
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Are fluent in speaking and reading the predominantly used or recognized language of the study site.
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Are able to swallow pills.
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Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions.
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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.
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Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
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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.
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Must not participate in any other interventional clinical trials during the duration of the study.
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Must commit to medication dosing, therapy, and study procedures.
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Have a current PTSD diagnosis at the time of screening.
Exclusion Criteria:
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Are not able to give adequate informed consent.
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Have uncontrolled hypertension.
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Have a marked baseline QTcF interval >450 milliseconds [ms] demonstrated on repeated ECG assessments.
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Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
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Have evidence or history of significant medical disorders.
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Have symptomatic liver or biliary disease.
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Have history of hyponatremia or hyperthermia.
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Weigh less than 48 kilograms (kg).
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Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
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Are abusing illegal drugs or alcohol.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Portland VA Research Foundation, Inc
- Steven & Alexandra Cohen Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 02