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 : April 21, 2023
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|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 each followed by four integrative therapy 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 :||May 2023|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
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 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 [ 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 Experimental 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.
- 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.
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: Kevin Rothstein-Kightly||360-450-9349||Kevin.Rothstein-Kightly@va.gov|
|Responsible Party:||Multidisciplinary Association for Psychedelic Studies|
|Other Study ID Numbers:||
|First Posted:||December 30, 2021 Key Record Dates|
|Last Update Posted:||April 21, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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