Posttraumatic Stress DisorderPhase 1/2NCT02876172
MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD
A Phase 1/2 study testing MDMA, CBCT and Therapy in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- MDMA, CBCT and Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2016to 29 May 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All inclusion criteria for the PTSD and Concerned Significant Other (CSO) are identical except for first two items, marked below:
- PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS
- CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner
- Are at least 18 years old
- If in psychotherapy, willing and able to maintain that schedule without changing it
- Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control.
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- Willing to remain overnight at the study site
- Are willing to be driven home the morning after the experimental sessions, after the integrative therapy session
- Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts
- Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
- Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control through 10 days after the last dose of MDMA.
- Must provide a contact (relative, spouse, close friend or other caregiver other than the CSO participant) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.
- Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
- Are proficient in speaking and reading English
- Agree to have all clinic visit and Integrative Sessions recorded to audio and video
- Agree to not participate in any other interventional clinical trials during the duration of this study
Who cannot join
- The following exclusions are identical for PTSD+ and CSO participants except for the following, marked below:
- CSO participant only: Have diagnosis of current PTSD not in remission
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
- Have evidence or history of significant medical disorders
- Have hypertension
- Have liver disease; asymptomatic participants with Hepatitis C who have previously undergone evaluation and successful treatment is permitted.
Show all 10Show fewer
- History of hyponatremia or hyperthermia
- Weigh less than 48 kg
- Have used "Ecstasy" (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the MDMA-assisted session
- Are not able to give adequate informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Offices of Michael Mithoefer MD
Mt. Pleasant, South Carolina, 29464
About this study
Official title: A Phase 1/2 Open-Label Treatment Development Study of Methylenedioxymethamphetamine (MDMA)-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)
The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners.
The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD?
Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.
Read the detailed description
Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD is a three-phase, 15-session, manualized treatment. This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective.
Each therapy team will have one therapist trained and experienced in MDMA-assisted therapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of midomafetamine HCl followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of midomafetamine HCl will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity scores in PTSD participants.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- MDMA, CBCT, Therapy
- Keywords
- PTSD, therapy, MDMA, dyad, cognitive behavioral 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.
MDMADrug
Also called 3,4-Methylenedioxymethamphetamine, midomafetamine
Two sessions of MDMA-assisted therapy, one with an initial dose of 75 mg midomafetamine HCl (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg midomafetamine HCl (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCTBehavioural
Also called Cognitive behavioral conjoint therapy
A three-phase, 15-session, manualized treatment from the CBCT manual
TherapyBehavioural
Manualized MDMA-assisted therapy
| Study group | Role | What they receive |
|---|---|---|
| MDMA-assisted therapy and CBCT | Experimental | Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy. Receives: Drug: MDMA; Behavioral: CBCT; Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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: Primary Endpoint (Visit 16, approximately 2 months later)
Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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 to Primary Endpoint (Visit 16, approximately 2 months later)
Secondary outcomes (18)
Baseline Pittsburgh Sleep Quality Index (PSQI)
Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality.
Measured: Baseline (screening)
Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)
Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Patient Beck Depression Inventory-II (BDI-II)
BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Measured: Baseline (screening)
Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)
BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Patient Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Measured: Baseline (screening)
Primary Endpoint Patient Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Partner Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Measured: Baseline (screening)
Primary Endpoint Partner Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Trauma and Attachment Beliefs Scale (TABS)
TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = "Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption.
Measured: Baseline (screening)
Primary Endpoint Trauma and Attachment Beliefs Scale (TABS)
TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = "Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal.
Measured: Baseline (screening)
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression.
Measured: Baseline (screening)
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Patient PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Measured: Baseline (screening)
Primary Endpoint Patient PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Partner-rated PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Measured: Baseline (screening)
Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Measured: Primary Endpoint (Visit 16, approximately 2 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start3 Jul 2016
- Primary completion16 Dec 2017
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael C Mithoefer, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876172
- Sponsor's protocol ID
- MPVA-1
- Status last verified
- May 2025
- First submitted
- 16 Aug 2016
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: We plan to share outcome measure data upon request
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-Label Treatment Development Study of Methylenedioxymethamphetamine (MDMA)-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02876172
- Acronym / sponsor ID
- MPVA-1
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, therapy, MDMA, dyad, cognitive behavioral therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2016 (actual)
- Primary completion
- 16 Dec 2017 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 19 Jul 2021
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 cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners.
The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD?
Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.
Detailed description
Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD is a three-phase, 15-session, manualized treatment. This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective.
Each therapy team will have one therapist trained and experienced in MDMA-assisted therapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of midomafetamine HCl followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of midomafetamine HCl will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity scores in PTSD participants.
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 and CBCT | Experimental | Drug: MDMA, Behavioral: CBCT, Behavioral: TherapyCognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- All inclusion criteria for the PTSD and Concerned Significant Other (CSO) are identical except for first two items, marked below:
- PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS
- CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner
- Are at least 18 years old
- If in psychotherapy, willing and able to maintain that schedule without changing it
Key exclusion criteria (10 listed)
- The following exclusions are identical for PTSD+ and CSO participants except for the following, marked below:
- CSO participant only: Have diagnosis of current PTSD not in remission
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
- Have evidence or history of significant medical disorders
- Have hypertension
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 |
|---|---|---|
| MDMAAlso: 3,4-Methylenedioxymethamphetamine, midomafetamineTwo sessions of MDMA-assisted therapy, one with an initial dose of 75 mg midomafetamine HCl (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg midomafetamine HCl (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other. | Drug | MDMA-assisted therapy and CBCT |
| CBCTAlso: Cognitive behavioral conjoint therapyA three-phase, 15-session, manualized treatment from the CBCT manual | Behavioural | MDMA-assisted therapy and CBCT |
| TherapyManualized MDMA-assisted therapy | Behavioural | MDMA-assisted therapy and CBCT |
Primary outcome
Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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 From Baseline to Primary Endpoint CAPS-5 Total Severity Score
Time frame: Baseline to Primary Endpoint (Visit 16, approximately 2 months later)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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.
18 secondary outcomes
Baseline Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (screening)
Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Patient Beck Depression Inventory-II (BDI-II)
Time frame: Baseline (screening)
Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Patient Couples Satisfaction Index (CSI)
Time frame: Baseline (screening)
Primary Endpoint Patient Couples Satisfaction Index (CSI)
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Partner Couples Satisfaction Index (CSI)
Time frame: Baseline (screening)
Primary Endpoint Partner Couples Satisfaction Index (CSI)
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Trauma and Attachment Beliefs Scale (TABS)
Time frame: Baseline (screening)
Primary Endpoint Trauma and Attachment Beliefs Scale (TABS)
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
Time frame: Baseline (screening)
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale
Time frame: Baseline (screening)
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Patient PTSD Checklist-5 (PCL-5)
Time frame: Baseline (screening)
Primary Endpoint Patient PTSD Checklist-5 (PCL-5)
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Baseline Partner-rated PTSD Checklist-5 (PCL-5)
Time frame: Baseline (screening)
Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5)
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We plan to share outcome measure data 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.
Michael C Mithoefer, MD principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MDMA, CBCT and Therapy in people with Posttraumatic Stress Disorder, run by Resilient Pharmaceuticals at 1 site in United States.
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 16 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score (time frame: Primary Endpoint (Visit 16, approximately 2 months later)). The study lists 2 primary outcomes in all. 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 4 Jun 2025.