PTSDPhase 2MPG1NCT05173831
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
A Phase 2 study testing Midomafetamine and Therapy in people with PTSD, run by Resilient Pharmaceuticals.
Trial summary
The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD. The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms? Participants will undergo non-drug preparatory therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Midomafetamine and Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Have a current PTSD diagnosis at the time of screening.
Who cannot join
- 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.
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- 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.
- Have an active illicit drug or prescription drug substance use disorder
About this study
Official title: An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans
The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD.
The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms?
Participants will undergo non-drug preparatory therapy sessions before their MDMA-assisted therapy sessions. After, they will undergo non-drug integrative therapy sessions.
Read the detailed description
To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a Phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA (120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later), along with non-drug preparatory and integrative therapy administered in both individual and group sessions.
The Primary 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.
- Conditions
- PTSD
- Being tested
- Midomafetamine, Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidomafetamineDrug
Also called 3,4-methylenedioxymethamphetamine, MDMA
Initial dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later
TherapyBehavioural
Manualized therapy performed by therapist team
| Study group | Role | What they receive |
|---|---|---|
| Two Sessions of MDMA-assisted therapy | Experimental | Two MDMA-assisted Therapy Sessions with 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later Receives: Drug: Midomafetamine; Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CAPS-5 Total Severity Score
The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure [114], including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score [114]. 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.
Measured: Baseline - 3 months from first Experimental Session
Secondary outcomes (1)
Change in Sheehan Disability Scale (SDS)
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.
Measured: Baseline - 3 months from First Experimental Session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study startSep 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Transfer of Sponsorship
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Stauffer, MD, Principal investigator, Associate Professor of Psychiatry at Oregon Health & Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173831
- Sponsor's protocol ID
- MPG1
- Acronym
- MPG1
- Status last verified
- Oct 2024
- First submitted
- 13 Dec 2021
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans
- ClinicalTrials.gov ID
- NCT05173831
- Acronym / sponsor ID
- MPG1 / MPG1
- Conditions
- PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Transfer of Sponsorship
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD.
The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms?
Participants will undergo non-drug preparatory therapy sessions before their MDMA-assisted therapy sessions. After, they will undergo non-drug integrative therapy sessions.
Detailed description
To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a Phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA (120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later), along with non-drug preparatory and integrative therapy administered in both individual and group sessions.
The Primary 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label study examining safety and effects of two sessions of MDMA-assisted therapy each followed by four integrative therapy sessions
| Arm | Type | Receives |
|---|---|---|
| Two Sessions of MDMA-assisted therapy | Experimental | Drug: Midomafetamine, Behavioral: TherapyTwo MDMA-assisted Therapy Sessions with 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidomafetamineAlso: 3,4-methylenedioxymethamphetamine, MDMAInitial dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later | Drug | Two Sessions of MDMA-assisted therapy |
| TherapyManualized therapy performed by therapist team | Behavioural | Two Sessions of MDMA-assisted therapy |
Primary outcome
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 [114], including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score [114]. 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.
1 secondary outcome
Change in Sheehan Disability Scale (SDS)
Time frame: Baseline - 3 months from First Experimental Session
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Stauffer, MD principal investigator
Associate Professor of Psychiatry at Oregon Health & Science University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midomafetamine and Therapy in people with PTSD, run by Resilient Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CAPS-5 Total Severity Score (time frame: Baseline - 3 months from first Experimental Session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.