Posttraumatic Stress DisorderPhase 2NCT01211405
Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder
A Phase 2 study testing Low dose MDMA-assisted therapy, Medium dose MDMA-assisted therapy and Full dose MDMA-assisted 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 MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms? Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which… 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?
- Low dose MDMA-assisted therapy, Medium dose MDMA-assisted therapy and Full dose MDMA-assisted therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2010to 2 Aug 2016
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.
- Are at least 18 years old;
- Must be generally healthy;
- Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
Show all 16Show fewer
- Are willing to refrain from taking any psychiatric medications during the study period;
- Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
- Willing to remain overnight at the study site;
- Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
- Are willing to be contacted via telephone for all necessary telephone contacts;
- Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;
- Must provide a contact in the event of a participant becoming suicidal;
- Are proficient in speaking and reading English;
- Agree to have all clinic visit sessions recorded to audio and video
- Agree not to participate in any other interventional clinical trials during the duration of this study.
Who cannot join
- Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
- Weigh less than 48 kg;
- Are abusing illegal drugs;
- Have used ecstasy (material representing itself as MDMA) more than 5 times or at least once in the last 6 months;
- Are unable to give adequate informed consent;
- Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
- Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Offices of Michael Mithoefer
Mt. Pleasant, South Carolina, 29464-4345
About this study
Official title: Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction With Manualized Therapy in 24 Veterans, Firefighters and Police Officers With Chronic Posttraumatic Stress Disorder (PTSD)
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms?
Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which dose best reduces PTSD symptoms.
Participants will undergo three preparatory non-drug therapy sessions with a male and female co-therapist team, then undergo three day-long MDMA-assisted therapy sessions after receiving an initial dose of 30, 75, or 125 mg MDMA HCl. After each MDMA-assisted therapy session, participants will undergo three integrative therapy sessions.
Read the detailed description
This study is a randomized, double-blind, dose comparison study with an open-label cross-over segment that will assess the safety and efficacy of MDMA-assisted therapy in veterans with chronic PTSD. Twelve of 24 participants will receive the full dose of 125 mg, six will receive 75 mg and six will receive 30 mg (active placebo dose) of MDMA HCl. An independent rater blind to condition will assess symptoms of PTSD and depression, general quality of life and posttraumatic growth prior to any therapy sessions one month after the second experimental session.
After undergoing three 90-minute non-drug introductory therapy sessions with a male/female co-therapist team, study participants will undergo two eight-hour long experimental sessions scheduled three to five weeks apart, prior to which they will be randomized to receive an initial dose of 30, 75 or 125 mg MDMA HCl , followed by a supplemental dose of half the initial dose 1.5 to 2.5 hours later. Participants will undergo integrative therapy in between each experimental session, including on the day after each session. Vital signs and psychological distress will be measured throughout each experimental session, and suicidality will be assessed throughout the course of the study. Spontaneously reported side effects will be collected on the day of each experimental session, and for six days afterward. PTSD symptoms, symptoms of depression, general psychological function, posttraumatic growth and quality of sleep will be assessed one month after the second experimental session, and the blind will be broken.
Participants who received 125 mg MDMA HCl will continue to have a third experimental session, and they will be assessed two months after the third experimental session.
Participants who received 30 or 75 mg MDMA HCl may take part in an open-label crossover segment that will follow nearly identical procedures, except that there will only be one introductory session prior to the first experimental session. There will be three experimental sessions. Symptoms of PTSD, depression and posttraumatic growth will be assessed at the start of the study. They will also be assessed one month after the second and two months after the third experimental session.
All participants will be assessed 12 months after their final experimental session. PTSD and depression symptoms and posttraumatic growth will be assessed, and participants will complete a questionnaire concerning the costs and benefits of being in the study.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Low dose MDMA-assisted therapy, Medium dose MDMA-assisted therapy, Full dose MDMA-assisted therapy, Therapy
- Keywords
- MDMA, Therapy, Veterans, Posttraumatic Stress Disorder
- 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.
Low dose MDMA-assisted therapyDrug
Also called MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine
30 mg midomafetamine HCl administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 15 mg 1.5 to 2 hours later
Medium dose MDMA-assisted therapyDrug
Also called MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine
75 mg midomafetamine HCl administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 37.5 mg 1.5 to 2 hours later
Full dose MDMA-assisted therapyDrug
Also called MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine
125 mg midomafetamine HCl administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 62.5 mg 1.5 to 2 hours later
TherapyBehavioural
Non-directive therapy during each session
| Study group | Role | What they receive |
|---|---|---|
| Low dose MDMA-assisted therapy | Active comparator | Participants will receive 30 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions. Receives: Drug: Low dose MDMA-assisted therapy; Behavioral: Therapy |
| Medium dose MDMA-assisted therapy | Active comparator | Participants will receive 75 mg midomafetamine HCl (MDMA) with therapy on each of two blinded experimental sessions. Receives: Drug: Medium dose MDMA-assisted therapy; Behavioral: Therapy |
| Full dose MDMA-assisted therapy | Experimental | Participants will receive 125 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions, followed by a third open label session. Receives: Drug: Full dose MDMA-assisted therapy; Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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 one month after second experimental session
Secondary outcomes (5)
Change in Global Assessment of Function (GAF) From Baseline to Primary Endpoint
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Measured: Baseline to one month after second experimental session
Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint
The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales; relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Questions are answered on a scale from 0 (I did not experience this change) to 5 (I experienced this change to a great degree). Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth.
Measured: Baseline to one month after second experimental session
Change in Beck Depression Inventory (BDI-II) From Baseline to Primary Endpoint
Validated self-report measure of symptoms of depression. 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 BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Measured: Baseline to one month after second experimental session
Change in Dissociative Experience Scale (DES-II) From Baseline to Primary Endpoint
The DES-II is a 28-item self-report measure of dissociation, defined as a lack of normal integration of an individual's thoughts, feelings, or experiences into the stream of consciousness or memory. Respondents indicate how often the specific experience happens to them, from "never" (0% of the time) to "always" (100%). The scale is scored by treating percentages as single digits and summing to produce a total score, ranging from 0 to 100. The higher the score, the more dissociative symptoms.
Measured: Baseline to one month after second experimental session
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Primary Endpoint
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Measured: Baseline to one month after second experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study start10 Nov 2010
- Primary completion4 Jun 2015
- Study completion2 Aug 2016
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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Mithoefer, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211405
- Sponsor's protocol ID
- MP-8
- Status last verified
- May 2025
- First submitted
- 6 Aug 2010
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: We will share de-identified outcome data appearing in any published reports upon request. IPD may include de-identified baseline, demographic and outcome measure data. To ensure participant privacy, it will never include PHI. Please contact the central trial contact for details about data sharing and data available.
Publications
Mithoefer MC, Mithoefer AT, Feduccia AA, Jerome L, Wagner M, Wymer J, Holland J, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Lancet Psychiatry. 2018 Jun;5(6):486-497. doi: 10.1016/S2215-0366(18)30135-4. Epub 2018 May 1.
PubMed 29728331Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4.
PubMed 32500209Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 2019.
PubMed 31572236Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology (Berl). 2019 Sep;236(9):2735-2745. doi: 10.1007/s00213-019-05249-5. Epub 2019 May 7.
PubMed 31065731
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction With Manualized Therapy in 24 Veterans, Firefighters and Police Officers With Chronic Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT01211405
- Acronym / sponsor ID
- MP-8
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- MDMA, Therapy, Veterans, Posttraumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2010 (actual)
- Primary completion
- 4 Jun 2015 (actual)
- Study completion
- 2 Aug 2016 (actual)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Posted 2 Feb 2022
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 therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms?
Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which dose best reduces PTSD symptoms.
Participants will undergo three preparatory non-drug therapy sessions with a male and female co-therapist team, then undergo three day-long MDMA-assisted therapy sessions after receiving an initial dose of 30, 75, or 125 mg MDMA HCl. After each MDMA-assisted therapy session, participants will undergo three integrative therapy sessions.
Detailed description
This study is a randomized, double-blind, dose comparison study with an open-label cross-over segment that will assess the safety and efficacy of MDMA-assisted therapy in veterans with chronic PTSD. Twelve of 24 participants will receive the full dose of 125 mg, six will receive 75 mg and six will receive 30 mg (active placebo dose) of MDMA HCl. An independent rater blind to condition will assess symptoms of PTSD and depression, general quality of life and posttraumatic growth prior to any therapy sessions one month after the second experimental session.
After undergoing three 90-minute non-drug introductory therapy sessions with a male/female co-therapist team, study participants will undergo two eight-hour long experimental sessions scheduled three to five weeks apart, prior to which they will be randomized to receive an initial dose of 30, 75 or 125 mg MDMA HCl , followed by a supplemental dose of half the initial dose 1.5 to 2.5 hours later. Participants will undergo integrative therapy in between each experimental session, including on the day after each session. Vital signs and psychological distress will be measured throughout each experimental session, and suicidality will be assessed throughout the course of the study. Spontaneously reported side effects will be collected on the day of each experimental session, and for six days afterward. PTSD symptoms, symptoms of depression, general psychological function, posttraumatic growth and quality of sleep will be assessed one month after the second experimental session, and the blind will be broken.
Participants who received 125 mg MDMA HCl will continue to have a third experimental session, and they will be assessed two months after the third experimental session.
Participants who received 30 or 75 mg MDMA HCl may take part in an open-label crossover segment that will follow nearly identical procedures, except that there will only be one introductory session prior to the first experimental session. There will be three experimental sessions. Symptoms of PTSD, depression and posttraumatic growth will be assessed at the start of the study. They will also be assessed one month after the second and two months after the third experimental session.
All participants will be assessed 12 months after their final experimental session. PTSD and depression symptoms and posttraumatic growth will be assessed, and participants will complete a questionnaire concerning the costs and benefits of being in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose MDMA-assisted therapy | Active comparator | Drug: Low dose MDMA-assisted therapy, Behavioral: TherapyParticipants will receive 30 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions. |
| Medium dose MDMA-assisted therapy | Active comparator | Drug: Medium dose MDMA-assisted therapy, Behavioral: TherapyParticipants will receive 75 mg midomafetamine HCl (MDMA) with therapy on each of two blinded experimental sessions. |
| Full dose MDMA-assisted therapy | Experimental | Drug: Full dose MDMA-assisted therapy, Behavioral: TherapyParticipants will receive 125 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions, followed by a third open label session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.
- Are at least 18 years old;
- Must be generally healthy;
Key exclusion criteria (7 listed)
- Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
- Weigh less than 48 kg;
- Are abusing illegal drugs;
- Have used ecstasy (material representing itself as MDMA) more than 5 times or at least once in the last 6 months;
- Are unable to give adequate informed consent;
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 |
|---|---|---|
| Low dose MDMA-assisted therapyAlso: MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine30 mg midomafetamine HCl administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 15 mg 1.5 to 2 hours later | Drug | Low dose MDMA-assisted therapy |
| Medium dose MDMA-assisted therapyAlso: MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine75 mg midomafetamine HCl administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 37.5 mg 1.5 to 2 hours later | Drug | Medium dose MDMA-assisted therapy |
| Full dose MDMA-assisted therapyAlso: MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine125 mg midomafetamine HCl administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 62.5 mg 1.5 to 2 hours later | Drug | Full dose MDMA-assisted therapy |
| TherapyNon-directive therapy during each session | Behavioural | Full dose MDMA-assisted therapy, Low dose MDMA-assisted therapy, Medium dose MDMA-assisted therapy |
Primary outcome
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint
Time frame: Baseline to one month after second experimental session
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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.
5 secondary outcomes
Change in Global Assessment of Function (GAF) From Baseline to Primary Endpoint
Time frame: Baseline to one month after second experimental session
Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint
Time frame: Baseline to one month after second experimental session
Change in Beck Depression Inventory (BDI-II) From Baseline to Primary Endpoint
Time frame: Baseline to one month after second experimental session
Change in Dissociative Experience Scale (DES-II) From Baseline to Primary Endpoint
Time frame: Baseline to one month after second experimental session
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Primary Endpoint
Time frame: Baseline to one month after second experimental session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29728331Mithoefer MC, Mithoefer AT, Feduccia AA, Jerome L, Wagner M, Wymer J, Holland J, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Lancet Psychiatry. 2018 Jun;5(6):486-497. doi: 10.1016/S2215-0366(18)30135-4. Epub 2018 May 1.
- Derived from this study: PubMed 32500209Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4.
- Derived from this study: PubMed 31572236Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 2019.
- Derived from this study: PubMed 31065731Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology (Berl). 2019 Sep;236(9):2735-2745. doi: 10.1007/s00213-019-05249-5. Epub 2019 May 7.
- Individual participant dataSharing planned: Yes. We will share de-identified outcome data appearing in any published reports upon request. IPD may include de-identified baseline, demographic and outcome measure data. To ensure participant privacy, it will never include PHI. Please contact the central trial contact for details about data sharing and data available.
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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 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 2 study testing Low dose MDMA-assisted therapy, Medium dose MDMA-assisted therapy and Full dose MDMA-assisted 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 7 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 5 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 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?
Yes. Results are posted in the registry (first posted 2 Feb 2022). 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?
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint (time frame: Baseline to one month after second experimental session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01211405, which also lists 4 linked publications.
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 5 Jun 2025.