Posttraumatic Stress DisorderPhase 2NUMCAP1NCT04968938
Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
A Phase 2 study testing midomafetamine and Therapy in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals.
Trial summary
The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD. The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will undergo three non-drug preparatory therapy sessions followed by two… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- 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
- Aug 2022to Aug 2023
- 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 fluent in speaking and reading a recognized language of the study site.
- Are able to swallow pills.
- Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions.
- Must provide a contact (relative, spouse, close friend, or other support person) 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.
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- If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
- Must not participate in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
- At baseline, have moderate PTSD diagnosis.
Who cannot join
- Are not able to give adequate informed consent.
- Have uncontrolled hypertension.
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and>460 ms in females corrected by Friderica's formula).
- 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 disease.
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- Have history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms (kg).
- Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
- Have current alcohol or substance use disorders.
About this study
Official title: A Phase 2, Open Label Study of the Safety and Effectiveness of MDMA-assisted Therapy for Participants With Posttraumatic Stress Disorder
The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD.
The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?
Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.
Read the detailed description
This Phase 2, open-label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants.
The Preparatory Period will consist of three 90-minute non-drug preparatory therapy sessions. A flexible divided dose of MDMA will be administered during the Treatment Period with manualized therapy in up to two open-label experimental sessions. During the Treatment Period, each experimental session is followed by three 90-minute non-drug integrative therapy sessions. The experimental sessions are scheduled roughly 3 to 5 weeks apart.
- Conditions
- Posttraumatic Stress Disorder
- 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 MDMA, midomafetamine HCl
80 mg or 120 mg midomafetamine HCl followed by a 40 mg supplement dose
TherapyBehavioural
Manualized therapy
| Study group | Role | What they receive |
|---|---|---|
| MDMA-assisted therapy | Experimental | Two sessions of MDMA-assisted therapy with an initial dose of 80 mg or 120 mg midomafetamine HCl and optional supplemental dose of 40 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 from Baseline in PTSD Checklist (adapted PCL-5) total score
20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. The gold standard for diagnosing PTSD is a structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS-5). When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis.The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."
Measured: 18 weeks post baseline post enrollment confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study startAug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: Sponsor decided not to pursue the study. Study ended prior to study start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- 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
- Devon Christie, MD, Principal investigator, Department of Medicine, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968938
- Sponsor's protocol ID
- NUMCAP1
- Acronym
- NUMCAP1
- Status last verified
- Oct 2024
- First submitted
- 9 Jul 2021
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share outcome data appearing in any published reports upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open Label Study of the Safety and Effectiveness of MDMA-assisted Therapy for Participants With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04968938
- Acronym / sponsor ID
- NUMCAP1 / NUMCAP1
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided not to pursue the study. Study ended prior to study start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 20 Jul 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 purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD.
The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?
Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.
Detailed description
This Phase 2, open-label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants.
The Preparatory Period will consist of three 90-minute non-drug preparatory therapy sessions. A flexible divided dose of MDMA will be administered during the Treatment Period with manualized therapy in up to two open-label experimental sessions. During the Treatment Period, each experimental session is followed by three 90-minute non-drug integrative therapy sessions. The experimental sessions are scheduled roughly 3 to 5 weeks apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA-assisted therapy | Experimental | Drug: midomafetamine, Behavioral: TherapyTwo sessions of MDMA-assisted therapy with an initial dose of 80 mg or 120 mg midomafetamine HCl and optional supplemental dose of 40 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 (9 listed)
- Are at least 18 years old.
- Are fluent in speaking and reading a recognized language of the study site.
- Are able to swallow pills.
- Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions.
- Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
Key exclusion criteria (10 listed)
- Are not able to give adequate informed consent.
- Have uncontrolled hypertension.
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and>460 ms in females corrected by Friderica's formula).
- 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: MDMA, midomafetamine HCl80 mg or 120 mg midomafetamine HCl followed by a 40 mg supplement dose | Drug | MDMA-assisted therapy |
| TherapyManualized therapy | Behavioural | MDMA-assisted therapy |
Primary outcome
Change from Baseline in PTSD Checklist (adapted PCL-5) total score
Time frame: 18 weeks post baseline post enrollment confirmation
20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. The gold standard for diagnosing PTSD is a structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS-5). When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis.The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."
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 1 Nov 2024.
- Individual participant dataSharing planned: Yes. We will share outcome data appearing in any published reports upon request.
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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.
Devon Christie, MD principal investigator
Department of Medicine, University of British Columbia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing midomafetamine and Therapy in people with Posttraumatic Stress Disorder, 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 9 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 1 Nov 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 from Baseline in PTSD Checklist (adapted PCL-5) total score (time frame: 18 weeks post baseline post enrollment confirmation). 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 1 Nov 2024.