PTSD, Post Traumatic Stress DisorderPhase 2NCT06353282
MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents
A Phase 2 study testing MDMA and Psychotherapy in people with PTSD, Post Traumatic Stress Disorder and Adolescents, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder, Adolescents, Psychotherapy
- What is being tested?
- MDMA and Psychotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 Dec 2026
- 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 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must meet DSM-5 criteria for current PTSD in response to a traumatic experience. An individual is not excluded if they experience more than one traumatic event. (Traumatic Event Screening Inventory for Children given to youth and caregiver, youth given CPSS if positive screen.)
- Participants must have treatment-resistant PTSD, as defined by having continued diagnosis of PTSD following at least 3-months of psychotherapy and pharmacotherapy. Psychotherapeutic treatments may include, but are not limited to, cognitive behavioral therapy (including trauma-focused cognitive behavioral therapy and exposure therapy, stress inoculation training, including anxiety management, and insight-oriented psychotherapy). Pharmacotherapies include selective serotonin reuptake inhibitors (SSRIs).
- Participants may also meet criteria for a mood (except bipolar disorder) or anxiety disorder. The inclusion of adolescents with either mood or anxiety disorders is essential given frequency of co-occurring disorders.
- Participants must be 16-17 years old at time of study screening.
- Participants; parents/caregivers must be willing to commit to two experimental sessions, therapy sessions, follow-up sessions, and completion of assessment parameters and instruments. Adolescents must assent.
- Participants must be willing to refrain from taking any psychotropic medication from the outset of the study until follow-up at 3 months. The scheduled outcome measures at 6 months will be conducted regardless of whether additional psychotropic medication was used. If they are being treated with psychoactive drugs at the time they are recruited into the study, agreement to suspend treatment must be obtained in writing from their outside treating physician. The drugs would be tapered in an appropriate fashion to avoid withdrawal effects (interval of at least five times the half-life).
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- Participants who are in ongoing psychotherapy at the time they are recruited into the study may continue to see their outside therapist during the course of the study. If they desire that the investigators communicate directly with the therapist, parents/caregivers must sign a release of information. They may not change therapists, increase the length and frequency of sessions, or commence a new type of therapy until one month following the second experimental medication session.
- Participants must agree that, for one week preceding each experimental session: They will refrain from taking any herbal supplement (except with prior approval of the research team). They will not take any nonprescription medications (with the exception of NSAIDs or acetaminophen unless with prior approval of the research team). Without the permission of their physician, they will not take any prescription medications (with the exception of birth control pills, thyroid hormones or other medications approved by the research team).
- Participants must agree to take nothing my mouth except alcohol-free liquids after midnight the evening before the experimental sessions. Patient must also refrain from the use of psychoactive substances, including caffeine and cannabis, within 24 hours of the experimental sessions and for 24 hours following the experimental sessions.
- Participants must be willing to be driven home by their parent/caregiver the evening of the experimental sessions and return with their parent/caregiver the following morning for the first integration therapy sessions.
- Participants must be willing to be contacted via telephone on a daily basis by one of the investigators for a week after the experimental sessions.
- Participants who do not adhere to the usual progression of scheduled visits, as may occur when a session is delayed, must agree to maintain weekly telephone contact with the study investigators, and must agree to speak with the investigators if there is a significant increase in symptoms for which they were previously medicated, if there is unanticipated need to contact their treating therapist, or if there are any changes in medication.
- Female participants must have a negative pregnancy test at study intake and must agree to use of an effective form of birth control.
- Participants must have sufficient proficiency in English to participate in psychotherapy in English. They and their parents/caregivers must be fluent in English and able to understand documents in English.
Who cannot join
- Participants who are experiencing current or at imminent risk for trauma and victimization as assessed by information gathered during the screening.
- Participants who appear to reside within an unsupportive and/or chaotic family structure (ex: Department of Child and Family Services (DCFS) involvement).
- Sexually active females who are not practicing an effective means of birth control.
- Participants with a personal or first-degree family history of a primary psychotic disorder or bipolar affective disorder.
- Participants with a personal history of an eating disorder, dissociative identity disorders, or borderline personality disorder.
- Participants with evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. Participants with hypothyroidism who are stable on thyroid replacement will not be excluded.
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- Any of the following cardiovascular conditions: hypertension, coronary artery disease, peripheral vascular disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, tachycardia, artificial heart valve, or any other significant cardiovascular condition.
- Resting blood pressure above 140 systolic, 90 diastolic (averaged across four separate measurements)
- Participants with hepatic disease, or history of hyponatremia or hyperthermia.
- Participants weighing less than 50 kg (30th percentile for 16 years and 25th percentile for 17 years) or more than 105 kg.
- Participants reporting any prior use of "ecstasy", methamphetamine, cocaine, heroin, misuse of prescription opiates or benzodiazepines.
- Participants meeting DSM 5 criteria for a substance use disorder.
- Participants with previous history of psychiatric hospitalization.
- Participants who would present with significant current suicidality (as measured by PHQ-9 and CRRRS) or who are deemed by the study team to need a higher level of care than the outpatient treatment the study is providing.
- Participants requiring ongoing concomitant therapy with psychoactive drug and unwilling or unable to taper off the medication(s) under physician supervision.
- Any participant whose parent/caregiver is not able to give adequate informed consent or any participant who is not able to give assent.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90095
About this study
Official title: 3, 4-methylenedioxymethamphetamine (MDMA) for Treatment-resistant Post-traumatic Stress Disorder (PTSD) in Adolescents
The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.
Read the detailed description
This study is an open-label fixed dose trial whereby youth with treatment-resistant post-traumatic stress disorder (PTSD) will be recruited. Treatment-resistant depression is defined as having continued Diagnostic Statistical Manual (DSM-5) diagnosis of PTSD following at least 3 months of psychotherapy and (either separately or combined) at least 3 months of SSRI pharmacotherapy. Before entering the trial, youth will undergo a preliminary medical and psychiatric screening to determine eligibility. Eligible youth will then proceed to 3-month MDMA-assisted psychotherapy, which includes 13 sessions of psychotherapy with two MDMA experimental medication sessions of 80mg and 120mg, respectively. Study assessments will include a baseline assessment, weekly assessments throughout the course of the treatment trial, and assessments at 3 months and 6 months post-treatment.
- Being tested
- MDMA, Psychotherapy
- Keywords
- PTSD, MDMA, Adolescent, Psychotherapy
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMADrug
MDMA will be dosed in pre-filled capsules and administered orally to participants in two fixed doses - an 80mg dose following the fourth session and a 120mg dose following the ninth session of MDMA to each participant. MDMA experimental medication administration session 1 (8 hours); MDMA experimental medication session 2 (8 hours). Participants will be required to remain in the therapy room for the duration of the experimental medication sessions without the youths' parent/guardian present. The parent/guardian will be invited to attend integration sessions and must be available to drop off and pick up the participant.
PsychotherapyBehavioural
Treatment session order: Four weekly 90-minute experimental medication preparation psychotherapy sessions; four weekly 90-minute psychotherapy integration sessions, starting the day following the preceding experimental medication session; and Five weekly 90-minute psychotherapy integration sessions, starting the day following the preceding experimental medication session.
| Study group | Role | What they receive |
|---|---|---|
| MDMA Psychotherapy | Experimental | Open-label fixed-dose trial whereby 10 youth with treatment-resistant PTSD will be recruited. Treatment-resistant depression is defined as having continued DSM-5 diagnosis of PTSD following at least 3 months of psychotherapy and (either separately or combined) at least 3 months SSRI pharmacotherapy. Prior to entering the trial, youth will undergo a preliminary medical and psychiatric screening to determine eligibility. Eligible youth will then proceed to 3-month MDMA-assisted psychotherapy, which includes 13 sessions of psychotherapy with two MDMA experimental medication sessions of 80mg and 120mg, respectively. Study assessments will include a baseline assessment, weekly assessments throughout the course of the treatment trial, and assessments at 3 months and 6 months post-treatment. Receives: Drug: MDMA; Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rhythm via Carnation Ambulatory Heart Monitor
Changes in heart rhythm via Carnation Ambulatory Heart Monitor
Measured: Throughout the 24 hours prior to each experimental medication session, throughout the duration of each drug administration session, and the 24 hours following each experimental medication session. Up to 64 hours.
Changes in blood pressure
changes in blood pressure as measured by blood pressure machine
Measured: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.
Change in pulse
Change in pulse as part of measuring vitals
Measured: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.
Change in body temperature
Changes in body temperature as measured by thermometer
Measured: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total
Mean change in score of visual analog scale to assess potential for misuse of MDMA
Investigate MDMA drug abuse potential through visual analog scale. Range for scale is 1-5 and will ask about the likability of the substance and the desire to use it in a non-clinical context.
Measured: Weekly throughout treatment and at 3-month and 6-month follow-ups. Through study completion, an average of 9 months
Secondary outcomes (4)
Mean change in PTSD symptom severity via the Child PTSD Symptom Scale
Change in PTSD symptom severity via the Child PTSD Symptom Scale (CPSS). The Child PTSD Symptom Scale (CPSS) measures posttraumatic stress disorder diagnosis and severity in the past month in children aged 8 to 18. Possible scores range from 0 to 80, with higher scores indicating a worse outcome/greater severity of symptoms.
Measured: Baseline, One month Post Experimental Session, and 3 and 6 months post-treatment. Through study completion, an average of 9 months
Mean change in PTSD symptom severity via the Clinician-Administered PTSD Scale (CAPS-CA-5)
Change in PTSD symptom severity via the CAPS-CA-5. The Clinician-Administered PTSD Scale(CAPS-CA-5) measures posttraumatic stress disorder symptoms in the past month in children aged 7 and above. Possible scores range from 0 to 80 , with higher scores indicating more severe PTSD symptoms.
Measured: Baseline, One month Post Experimental Session, and 3 and 6 months post-treatment. Through study completion, an average of 9 months
Mean change in depression symptom severity via the Patient Health Questionnaire-9 (PHQ-9).
Change in depressive symptom severity via the PHQ-9. The Patient Health Questionnaire-9 (PHQ-9) measures the severity of depression. Possible scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline and at each study visit following MDMA experimental medication sessions. Through study completion, an average of 9 months
Mean change in anxiety symptom severity via the Generalized Anxiety Disorder 7-item (GAD-7)
Change in Anxiety symptoms assessed by the GAD-7. Generalized Anxiety Disorder 7-item scale measures the severity of anxiety. Possible scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Measured: Baseline and at each study visit following the experimental medication sessions. Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Under review with FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD, Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Jeffrey, MD, MPH, MBA, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353282
- Sponsor's protocol ID
- 24-000795
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3, 4-methylenedioxymethamphetamine (MDMA) for Treatment-resistant Post-traumatic Stress Disorder (PTSD) in Adolescents
- ClinicalTrials.gov ID
- NCT06353282
- Acronym / sponsor ID
- 24-000795
- Keywords
- PTSD, MDMA, Adolescent, Psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Under review with FDA
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.
Detailed description
This study is an open-label fixed dose trial whereby youth with treatment-resistant post-traumatic stress disorder (PTSD) will be recruited. Treatment-resistant depression is defined as having continued Diagnostic Statistical Manual (DSM-5) diagnosis of PTSD following at least 3 months of psychotherapy and (either separately or combined) at least 3 months of SSRI pharmacotherapy. Before entering the trial, youth will undergo a preliminary medical and psychiatric screening to determine eligibility. Eligible youth will then proceed to 3-month MDMA-assisted psychotherapy, which includes 13 sessions of psychotherapy with two MDMA experimental medication sessions of 80mg and 120mg, respectively. Study assessments will include a baseline assessment, weekly assessments throughout the course of the treatment trial, and assessments at 3 months and 6 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA Psychotherapy | Experimental | Drug: MDMA, Behavioral: PsychotherapyOpen-label fixed-dose trial whereby 10 youth with treatment-resistant PTSD will be recruited. Treatment-resistant depression is defined as having continued DSM-5 diagnosis of PTSD following at least 3 months of psychotherapy and (either separately or combined) at least 3 months SSRI pharmacotherapy. Prior to entering the trial, youth will undergo a preliminary medical and psychiatric screening to determine eligibility. Eligible youth will then proceed to 3-month MDMA-assisted psychotherapy, which includes 13 sessions of psychotherapy with two MDMA experimental medication sessions of 80mg and 120mg, respectively. Study assessments will include a baseline assessment, weekly assessments throughout the course of the treatment trial, and assessments at 3 months and 6 months post-treatment. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Participants must meet DSM-5 criteria for current PTSD in response to a traumatic experience. An individual is not excluded if they experience more than one traumatic event. (Traumatic Event Screening Inventory for Children given to youth and caregiver, youth given CPSS if positive screen.)
- Participants must have treatment-resistant PTSD, as defined by having continued diagnosis of PTSD following at least 3-months of psychotherapy and pharmacotherapy. Psychotherapeutic treatments may include, but are not limited to, cognitive behavioral therapy (including trauma-focused cognitive behavioral therapy and exposure therapy, stress inoculation training, including anxiety management, and insight-oriented psychotherapy). Pharmacotherapies include selective serotonin reuptake inhibitors (SSRIs).
- Participants may also meet criteria for a mood (except bipolar disorder) or anxiety disorder. The inclusion of adolescents with either mood or anxiety disorders is essential given frequency of co-occurring disorders.
- Participants must be 16-17 years old at time of study screening.
- Participants; parents/caregivers must be willing to commit to two experimental sessions, therapy sessions, follow-up sessions, and completion of assessment parameters and instruments. Adolescents must assent.
Key exclusion criteria (16 listed)
- Participants who are experiencing current or at imminent risk for trauma and victimization as assessed by information gathered during the screening.
- Participants who appear to reside within an unsupportive and/or chaotic family structure (ex: Department of Child and Family Services (DCFS) involvement).
- Sexually active females who are not practicing an effective means of birth control.
- Participants with a personal or first-degree family history of a primary psychotic disorder or bipolar affective disorder.
- Participants with a personal history of an eating disorder, dissociative identity disorders, or borderline personality disorder.
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 |
|---|---|---|
| MDMAMDMA will be dosed in pre-filled capsules and administered orally to participants in two fixed doses - an 80mg dose following the fourth session and a 120mg dose following the ninth session of MDMA to each participant. MDMA experimental medication administration session 1 (8 hours); MDMA experimental medication session 2 (8 hours). Participants will be required to remain in the therapy room for the duration of the experimental medication sessions without the youths' parent/guardian present. The parent/guardian will be invited to attend integration sessions and must be available to drop off and pick up the participant. | Drug | MDMA Psychotherapy |
| PsychotherapyTreatment session order: Four weekly 90-minute experimental medication preparation psychotherapy sessions; four weekly 90-minute psychotherapy integration sessions, starting the day following the preceding experimental medication session; and Five weekly 90-minute psychotherapy integration sessions, starting the day following the preceding experimental medication session. | Behavioural | MDMA Psychotherapy |
Primary outcome
Changes in heart rhythm via Carnation Ambulatory Heart Monitor
Time frame: Throughout the 24 hours prior to each experimental medication session, throughout the duration of each drug administration session, and the 24 hours following each experimental medication session. Up to 64 hours.
Changes in heart rhythm via Carnation Ambulatory Heart Monitor
Changes in blood pressure
Time frame: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.
changes in blood pressure as measured by blood pressure machine
Change in pulse
Time frame: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.
Change in pulse as part of measuring vitals
Change in body temperature
Time frame: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total
Changes in body temperature as measured by thermometer
Mean change in score of visual analog scale to assess potential for misuse of MDMA
Time frame: Weekly throughout treatment and at 3-month and 6-month follow-ups. Through study completion, an average of 9 months
Investigate MDMA drug abuse potential through visual analog scale. Range for scale is 1-5 and will ask about the likability of the substance and the desire to use it in a non-clinical context.
4 secondary outcomes
Mean change in PTSD symptom severity via the Child PTSD Symptom Scale
Time frame: Baseline, One month Post Experimental Session, and 3 and 6 months post-treatment. Through study completion, an average of 9 months
Mean change in PTSD symptom severity via the Clinician-Administered PTSD Scale (CAPS-CA-5)
Time frame: Baseline, One month Post Experimental Session, and 3 and 6 months post-treatment. Through study completion, an average of 9 months
Mean change in depression symptom severity via the Patient Health Questionnaire-9 (PHQ-9).
Time frame: Baseline and at each study visit following MDMA experimental medication sessions. Through study completion, an average of 9 months
Mean change in anxiety symptom severity via the Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline and at each study visit following the experimental medication sessions. Through study completion, an average of 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MDMA and Psychotherapy in people with PTSD, Post Traumatic Stress Disorder and Adolescents, run by University of California, Los Angeles 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 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 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 was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rhythm via Carnation Ambulatory Heart Monitor (time frame: Throughout the 24 hours prior to each experimental medication session, throughout the duration of each drug administration session, and the 24 hours following each experimental medication session. Up to 64 hours.). The study lists 5 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 10 Apr 2025.