Post Traumatic Stress DisorderPhase 2VALLMDMA_001NCT04264026
MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD
A Phase 2 study testing 3,4-methylenedioxymethamphetamine in people with Post Traumatic Stress Disorder and Combat Stress Disorders, run by VA Loma Linda Health Care System at 1 site in United States.
Trial summary
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Combat Stress Disorders
- What is being tested?
- 3,4-methylenedioxymethamphetamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 1 May 2025
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be eligible for VA healthcare and currently being treated by VA Loma Linda Healthcare System or VA Long Beach providers
- Participants must meet DSM 5 criteria for combat-related PTSD (within the past 6 months). PTSD must be defined as treatment-resistant.
- Participants must have been exposed to combat in the current-era war.
- Participants must be 18-55 years old.
- Participants must be generally healthy overall without any significant medical comorbidities (see exclusion criteria).
- Participants must be willing to refrain from alcohol for 72 hours prior to each MDMA session and be deemed not at risk for significant alcohol withdrawal.
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- Participants must be willing to refrain from taking any psychiatric medications during the study period, including gabapentin or any other anticonvulsants. If they are being treated with psychoactive medications during recruitment, participants must be willing and determined safe (by study physician(s)) to undergo medically-supervised withdrawal from these medications. The medications will be withdrawn in an appropriate fashion to minimize any withdrawal effects. The participants must be able to refrain from starting any new medications during the study period. The only exception to this will be in the case of rescue medications that may be administered in the event of a crisis during the experimental study sessions.
- Agree that, for one week preceding an MDMA session will refrain from:
- Taking any herbal supplement (except with prior approval of the research team);
- Taking any nonprescription medications (with the exception of non-steroidal anti-inflammatory drugs or acetaminophen unless with prior approval of the research team);
- Taking any prescription medications, with the exception of birth control pills, thyroid hormones or other medications approved by the research team.
- Are proficient in speaking and reading English.
- Must meet capacity and consent for treatment.
- Participants who are engaged in non-PTSD psychotherapy at the time of study screening, may continue to see their therapist during the course of the study. If seeing a non-VA therapist, participants must sign a release for the investigators to communicate directly with their therapist. Subjects may not change therapists, increase the frequency of therapy or commence any new type of therapy until after the evaluation session 2 months after the final experimental session.
- Participants of childbearing potential and age must have a negative pregnancy test and must agree to use an effective form of birth control during the study period.
- Participants must be willing to stay overnight at the hospital after each experimental session.
- Agree to have transportation other than driving themselves home on the day after an MDMA session.
- Are willing to follow restrictions and guidelines concerning medications, consumption of food, beverages, alcohol, nicotine, or illicit substances.
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal.
- Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
- Agree to not participate in any other interventional clinical trials during the duration of this study.
- Must be able to swallow pills.
Who cannot join
- Individuals with only non-combat related PTSD. Note: participants will not be excluded for having multiple traumas so long as one of those is combat-related.
- Participants currently engaged in PTSD psychotherapy.
- Individuals that are determined medically unstable, unsafe for outpatient detoxification from alcohol, at risk for severe alcohol withdrawal, or unwilling/unable to refrain from alcohol use for at least 72 hours prior to experimental session.
- Lack a stable living situation or supportive system.
- Any person unable to give adequate informed consent.
- Participants of childbearing potential who are pregnant, nursing, or of childbearing age unwilling/unable to practice an effective means of birth control.
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- People with a history of, or a current psychotic disorder, dissociative disorder, bipolar affective disorder or personality disorders.
- Have a current eating disorder.
- Have current major depressive disorder with psychotic features.
- Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
- People with evidence or history of significant hematological, cardiovascular, cerebrovascular, coronary, pulmonary, endocrine, renal, gastrointestinal, hepatic (including LFTs > 3x upper limit of normal), immunocompromising (examples include recent organ transplant and required to be on immunosuppressants, those with HIV/AIDs, cancer or an autoimmune disease [i.e., lupus, multiple sclerosis, rheumatoid arthritis]), neurological disease (including seizure disorder or cognitive impairment). Patients with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded.
- Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions).
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] for men or >470 ms for women corrected by Bazett's formula).
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions.
- Have history of hyponatremia or hyperthermia.
- People weighing less than 50 kg.
- People with prior use of "Ecstasy" (illicit drug preparations purported to contain MDMA) more than ten times within the past ten years or at any time within the past 6 months or have previously participated in a MAPS-sponsored MDMA clinical trial.
- People with ketamine use within the last 12 weeks.
- People with a serious suicide risk or who are likely to require hospitalization within the course of the study.
- Individuals who require ongoing treatment with psychoactive medications.
- Individuals meeting DSM-5 criteria for active substance use disorder for any substance other than caffeine or nicotine assessed.
- Patients in a residential or intensive outpatient treatment program for substance use will be excluded (patients engaged in self-help program such as after care and relapse prevention and alcoholics-anonymous can be included).
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
- Unable to ensure reliable transportation to and from study visits or have unstable housing.
- Any potential participant presenting current serious suicide risk, as determined through psychiatric interview, responses to questionnaires, and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior will be excluded.
- Any potential participant with a C-SSRS Suicidal Ideation score of 5 during the prior six months, or with a suicidal ideation of 4 occurring more frequently than one day per week within the past month will be excluded.
- Regardless of C-SSRS score, any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempt is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Loma Linda Health Care System
Loma Linda, California, 92357
About this study
Official title: Open-label Phase 2 Study of MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System.
The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected.
The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.
Read the detailed description
This will be a single-site, open-label study, investigating the use of MDMA-assisted psychotherapy for treatment-resistant combat-related PTSD. This study will consent up to 50 current-era combat veterans for study and the first 10 participants who meet criteria will be eligible to receive study medication. Any patient who drops out before the third Experimental Session will be replaced. Dropout rates will be recorded. In this protocol, enrollment is defined as the time the participant signs informed consent. Time from initial screening/enrollment to collection of the primary endpoint will last approximately 12-18 weeks. To assess durability of treatment, participants will be assessed approximately 12 months after the last MDMA session for the long-term follow-up. The study will consist of a prescreening/screening/enrollment period, three pre-experimental (preparatory) dose psychotherapy sessions (spaced approximately one week apart), three experimental dose therapy sessions, nine integrative follow-up sessions, one assessment of primary endpoint, and a long-term 12-month follow-up assessment. Psychiatric medication tapering will occur after eligibility confirmation (after completion of baseline CAPS-5, prior to Experiential Sessions) to allow for appropriate medication washout.
The primary objective of this study is to evaluate the safety and effectiveness of MDMA in Veterans with combat-related, refractory PTSD when used in conjunction with manualized psychotherapy on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures.
Effectiveness will be measured by evaluating the change in CAPS-5 scores from baseline to the primary endpoint. Primary endpoint will be collected 2 months after the third Experimental Session with MDMA. To access long-term effectiveness, CAPS-5 will also be collected at the long-term follow-up.
Secondary Objectives:
- Assess changes in self-reported PTSD symptoms as measured with the PTSD-symptom checklist at screening and baseline, during most face-to-face visits, at the primary endpoint, and during the long-term follow-up.
- Life Event Checklist (LEC) for PCL-5 will be administered at baseline (screening), primary endpoint, and long-term follow-up.
- Assess depression symptoms with the Beck Depression Inventory-II (BDI-II) at baseline (screening), primary endpoint, and long-term 12-month follow-up.
- Assess changes in alcohol consumption.
- The AUDIT-C (Alcohol Use Disorders Identification Test) will be used to measure baseline alcohol use over the past year prior to study entry (at screening) and at long-term follow up.
- Alcohol use starting after study screening will be monitored based on participants self-report. Participants will be directed to keep a Drinking Diary throughout the study measuring the number of standard alcoholic beverages consumed per day. Drinking Diary for each participant will be collected weekly until their last psychotherapy visit. Participants will continue to record weekly alcohol use on their own until collection at the primary endpoint.
- Assess changes in drug consumption.
- Drug Use Disorders Identification Test (DUDIT) will be assessed at baseline (screening) and at long-term follow-up).
- Assess changes in self-reported sleep quality via the Pittsburgh Sleep Quality Index (PSQI) from baseline (screening) to primary endpoint and long-term 12-month follow-up.
- Assess changes in posttraumatic growth via Post Traumatic Growth Inventory (PTGI) scores from baseline (at screening) to primary endpoint and long-term 12-month follow-up.
- Healthcare utilization will also be assessed by retrospective chart review.
Twelve months after the final Experimental Session, the long-term effects of MDMA-assisted psychotherapy on symptoms of PTSD will be assessed via CAPS-5 and PCL-5 with LEC, alcohol use via AUDIT, drug use behaviors via DUDIT, depression via BDI-II, self-reported sleep quality via PSQI, post-traumatic growth via PTGI, suicidality via C-SSRS, and response to research participation via RRPQ (Reactions to Research Participation Questionnaire).
Participants will also be assessed for suicidality at every face-to-face visit.
- Being tested
- 3,4-methylenedioxymethamphetamine
- Keywords
- Veterans, Refractory PTSD, PTSD, MDMA
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,4-methylenedioxymethamphetamineDrug
Also called MDMA
Bottles are labeled with a unique container number, protocol number, IMP name, lot number, sponsor name and a statement that the IMP is restricted to clinical trial use only.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Participants will receive an initial dose of 80 mg of 3,4-methylenedioxymethamphetamine (MDMA) and an optional supplemental dose of 40 mg MDMA during the first Experimental Session. In the second and third Experimental Sessions, the participant will receive an initial dose of 120 mg MDMA and an optional supplemental dose of 40 mg MDMA. Receives: Drug: 3,4-methylenedioxymethamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score of CAPS-5
The primary objective was amended in January 2024. The study will now aim to explore the feasibility of MDMA used in conjunction with manualized psychotherapy on reduction of symptoms, or remission of combat-related treatment resistant PTSD, as evaluated by standard clinical measures as a multiple case series.
Measured: baseline, primary outcome (2 months after last experimental/MDMA session), 12-month follow-up
Secondary outcomes (7)
Changes in self-reported PTSD symptoms
Assess changes in self-reported PTSD symptoms as measured with the PTSD-symptom checklist (PCL-5)
Measured: baseline, primary outcome (2 months after last experimental/MDMA session), 12-month follow up
Depression Symptoms
Assess depression symptoms with the Beck Depression Inventory-II. The Beck Depression Inventory-II (BDI-II) is a 21-item self-report measure of depressive symptoms, with scores ranging from 0 to 63, higher scores indicative of greater (more severe) depression.
Measured: through study completion, an average of 1 year
Changes in Alcohol Consumption
Assess changes in alcohol consumption.
- The AUDIT-C (Alcohol Use Disorders Identification Test) will be used to measure baseline alcohol use over the past year prior to study entry (at screening) and at long-term follow up (V18).
- Alcohol use starting after study screening will be monitored based on participants selfreport.
Participants will be directed to keep a Drinking Diary throughout the study measuring the number of standard alcoholic beverages consumed per day.
Measured: through study completion, an average of 1 year
Changes in Drug Consumption
Drug Use Disorders Identification Test (DUDIT) will be assessed
Measured: Baseline (screening) and long-term 12-month follow up (V18)
Changes in self-reported sleep quality
Assess changes in self-reported sleep quality via the Pittsburgh Sleep Quality Index (PSQI). It consists of 19 items, with possible responses ranging from 0 to 4 on a five-point scale. Global scores can range from 0 to 21, with higher scores reflecting poorer sleep quality, and a score below 5 indicating good sleep.
Measured: through study completion, an average of 1 year
Changes in posttraumatic growth
Assess changes in posttraumatic growth via Post Traumatic Growth Inventory (PTGI) scores. The Post Traumatic Growth Inventory (PTGI)115-116 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. Higher scores implies that the person has undergone a positive transformation.
Measured: through study completion, an average of 1 year
Healthcare Utilization
Healthcare utilization will also be assessed by retrospective chart review to determine psychotherapy treatment history in comparison from baseline to study end.
Measured: Baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start29 Jul 2021
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic 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
- Model description
- Single-site, open-label study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Loma Linda Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Multidisciplinary Association for Psychedelic Studies
- Responsible party
- Principal investigator, Shannon Remick, VA Loma Linda Health Care System
- Investigators
- Shannon Remick, MD, Principal investigator, Staff Psychiatrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264026
- Sponsor's protocol ID
- 1311
- Acronym
- VALLMDMA_001
- Status last verified
- Jul 2025
- First submitted
- 7 Feb 2020
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phase 2 Study of MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD
- ClinicalTrials.gov ID
- NCT04264026
- Acronym / sponsor ID
- VALLMDMA_001 / 1311
- Keywords
- Veterans, Refractory PTSD, PTSD, MDMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- VA Loma Linda Health Care SystemUS federal agency
- Collaborators
- Multidisciplinary Association for Psychedelic Studies
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 11 Feb 2020 (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.
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System.
The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected.
The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.
Detailed description
This will be a single-site, open-label study, investigating the use of MDMA-assisted psychotherapy for treatment-resistant combat-related PTSD. This study will consent up to 50 current-era combat veterans for study and the first 10 participants who meet criteria will be eligible to receive study medication. Any patient who drops out before the third Experimental Session will be replaced. Dropout rates will be recorded. In this protocol, enrollment is defined as the time the participant signs informed consent. Time from initial screening/enrollment to collection of the primary endpoint will last approximately 12-18 weeks. To assess durability of treatment, participants will be assessed approximately 12 months after the last MDMA session for the long-term follow-up. The study will consist of a prescreening/screening/enrollment period, three pre-experimental (preparatory) dose psychotherapy sessions (spaced approximately one week apart), three experimental dose therapy sessions, nine integrative follow-up sessions, one assessment of primary endpoint, and a long-term 12-month follow-up assessment. Psychiatric medication tapering will occur after eligibility confirmation (after completion of baseline CAPS-5, prior to Experiential Sessions) to allow for appropriate medication washout.
The primary objective of this study is to evaluate the safety and effectiveness of MDMA in Veterans with combat-related, refractory PTSD when used in conjunction with manualized psychotherapy on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures.
Effectiveness will be measured by evaluating the change in CAPS-5 scores from baseline to the primary endpoint. Primary endpoint will be collected 2 months after the third Experimental Session with MDMA. To access long-term effectiveness, CAPS-5 will also be collected at the long-term follow-up.
Secondary Objectives:
- Assess changes in self-reported PTSD symptoms as measured with the PTSD-symptom checklist at screening and baseline, during most face-to-face visits, at the primary endpoint, and during the long-term follow-up.
- Life Event Checklist (LEC) for PCL-5 will be administered at baseline (screening), primary endpoint, and long-term follow-up.
- Assess depression symptoms with the Beck Depression Inventory-II (BDI-II) at baseline (screening), primary endpoint, and long-term 12-month follow-up.
- Assess changes in alcohol consumption.
- The AUDIT-C (Alcohol Use Disorders Identification Test) will be used to measure baseline alcohol use over the past year prior to study entry (at screening) and at long-term follow up.
- Alcohol use starting after study screening will be monitored based on participants self-report. Participants will be directed to keep a Drinking Diary throughout the study measuring the number of standard alcoholic beverages consumed per day. Drinking Diary for each participant will be collected weekly until their last psychotherapy visit. Participants will continue to record weekly alcohol use on their own until collection at the primary endpoint.
- Assess changes in drug consumption.
- Drug Use Disorders Identification Test (DUDIT) will be assessed at baseline (screening) and at long-term follow-up).
- Assess changes in self-reported sleep quality via the Pittsburgh Sleep Quality Index (PSQI) from baseline (screening) to primary endpoint and long-term 12-month follow-up.
- Assess changes in posttraumatic growth via Post Traumatic Growth Inventory (PTGI) scores from baseline (at screening) to primary endpoint and long-term 12-month follow-up.
- Healthcare utilization will also be assessed by retrospective chart review.
Twelve months after the final Experimental Session, the long-term effects of MDMA-assisted psychotherapy on symptoms of PTSD will be assessed via CAPS-5 and PCL-5 with LEC, alcohol use via AUDIT, drug use behaviors via DUDIT, depression via BDI-II, self-reported sleep quality via PSQI, post-traumatic growth via PTGI, suicidality via C-SSRS, and response to research participation via RRPQ (Reactions to Research Participation Questionnaire).
Participants will also be assessed for suicidality at every face-to-face visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-site, open-label study
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: 3,4-methylenedioxymethamphetamineParticipants will receive an initial dose of 80 mg of 3,4-methylenedioxymethamphetamine (MDMA) and an optional supplemental dose of 40 mg MDMA during the first Experimental Session. In the second and third Experimental Sessions, the participant will receive an initial dose of 120 mg MDMA and an optional supplemental dose of 40 mg MDMA. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Participants must be eligible for VA healthcare and currently being treated by VA Loma Linda Healthcare System or VA Long Beach providers
- Participants must meet DSM 5 criteria for combat-related PTSD (within the past 6 months). PTSD must be defined as treatment-resistant.
- Participants must have been exposed to combat in the current-era war.
- Participants must be 18-55 years old.
- Participants must be generally healthy overall without any significant medical comorbidities (see exclusion criteria).
Key exclusion criteria (29 listed)
- Individuals with only non-combat related PTSD. Note: participants will not be excluded for having multiple traumas so long as one of those is combat-related.
- Participants currently engaged in PTSD psychotherapy.
- Individuals that are determined medically unstable, unsafe for outpatient detoxification from alcohol, at risk for severe alcohol withdrawal, or unwilling/unable to refrain from alcohol use for at least 72 hours prior to experimental session.
- Lack a stable living situation or supportive system.
- Any person 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 |
|---|---|---|
| 3,4-methylenedioxymethamphetamineAlso: MDMABottles are labeled with a unique container number, protocol number, IMP name, lot number, sponsor name and a statement that the IMP is restricted to clinical trial use only. | Drug | Open Label |
Primary outcome
Change in total score of CAPS-5
Time frame: baseline, primary outcome (2 months after last experimental/MDMA session), 12-month follow-up
The primary objective was amended in January 2024. The study will now aim to explore the feasibility of MDMA used in conjunction with manualized psychotherapy on reduction of symptoms, or remission of combat-related treatment resistant PTSD, as evaluated by standard clinical measures as a multiple case series.
7 secondary outcomes
Changes in self-reported PTSD symptoms
Time frame: baseline, primary outcome (2 months after last experimental/MDMA session), 12-month follow up
Depression Symptoms
Time frame: through study completion, an average of 1 year
Changes in Alcohol Consumption
Time frame: through study completion, an average of 1 year
Changes in Drug Consumption
Time frame: Baseline (screening) and long-term 12-month follow up (V18)
Changes in self-reported sleep quality
Time frame: through study completion, an average of 1 year
Changes in posttraumatic growth
Time frame: through study completion, an average of 1 year
Healthcare Utilization
Time frame: Baseline through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No. No sharing planned
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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.
Shannon Remick, MD principal investigator
Staff Psychiatrist
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 3,4-methylenedioxymethamphetamine in people with Post Traumatic Stress Disorder and Combat Stress Disorders, run by VA Loma Linda Health Care System 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 22 inclusion and 29 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 20 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 total score of CAPS-5 (time frame: baseline, primary outcome (2 months after last experimental/MDMA session), 12-month follow-up). 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 20 Jul 2025.