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.
Group MDMA-therapy for Veterans With PTSD
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.
Intervention / Treatment
Open-label study examining safety and feasibility of MDMA-assisted group therapy
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MDMA (DRUG)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
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Group Therapy (BEHAVIORAL)Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy
Condition or Disease
- PTSD
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Not yet recruiting |
| Study results: | No Results Available |
| Enrollment: | 18 (ESTIMATED) |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
MaskingIndependent raters for the primary clinical outcome will be blinded to study design and timepoint. |
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Clinical Trial Dates
| Start date: | Oct 01, 2023 | ESTIMATED |
|---|---|---|
| Primary Completion: | Jul 31, 2025 | ESTIMATED |
| Completion Date: | Sep 30, 2025 | ESTIMATED |
| Study First Posted: | Jul 27, 2023 | ACTUAL |
| Last Updated: | Jul 17, 2023 |
Sponsors / Collaborators
Lead Sponsor:
Portland VA Research Foundation, Inc
Responsible Party:
Christopher Stauffer
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.
Participant Groups
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Four Preparatory Sessions, two MDMA Sessions, and four Integrative Sessions following each MDMA Session.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Are at least 18 years old.
* Are a U.S. Military Veteran
* Are fluent in speaking and reading the predominantly used or recognized language of the study site.
* Are able to swallow pills.
* Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions.
* 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.
* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
* 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.
* Must not participate in any other interventional clinical trials during the duration of the study.
* Must commit to medication dosing, therapy, and study procedures.
* Have a current PTSD diagnosis at the time of screening.
Exclusion Criteria:
* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments.
* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
* Have evidence or history of significant medical disorders.
* Have symptomatic liver or biliary disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
* Are abusing illegal drugs or alcohol.
* Are at least 18 years old.
* Are a U.S. Military Veteran
* Are fluent in speaking and reading the predominantly used or recognized language of the study site.
* Are able to swallow pills.
* Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions.
* 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.
* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
* 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.
* Must not participate in any other interventional clinical trials during the duration of the study.
* Must commit to medication dosing, therapy, and study procedures.
* Have a current PTSD diagnosis at the time of screening.
Exclusion Criteria:
* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments.
* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
* Have evidence or history of significant medical disorders.
* Have symptomatic liver or biliary disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
* Are abusing illegal drugs or alcohol.
Primary Outcomes
Secondary Outcomes
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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.
More Details
| NCT Number: | NCT05961527 |
|---|---|
| Other IDs: | 02 |
| Study URL: | https://clinicaltrials.gov/study/NCT05961527 |
Last updated: Sep 29, 2023