MDMA-Assisted Psychotherapy for PTSD in Adolescents

Overseen By Marc J Weintraub, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must not be taking: Psychoactive drugs, Benzodiazepines

Disqualifiers: Psychotic disorder, Cardiovascular conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MDMA-assisted psychotherapy can safely and effectively treat young people aged 16-17 with PTSD, a mental health condition triggered by experiencing or witnessing a traumatic event, that hasn’t improved with standard treatments. Participants will undergo two sessions with MDMA (sometimes called "ecstasy") combined with talk therapy over three months. Those who have had PTSD despite three months of therapy and medication might be suitable if they are willing to refrain from other medications during the trial and commit to all sessions and follow-ups. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any psychotropic medications (drugs that affect your mind) from the start of the study until the follow-up at 3 months. If you're on these medications when you join, you'll need to get your doctor's written agreement to stop them, and they will be gradually reduced to avoid withdrawal effects.

Is there any evidence suggesting that MDMA-assisted psychotherapy is likely to be safe for humans?

Research has shown that MDMA-assisted therapy can be safe for treating PTSD. Studies indicate that MDMA does not typically cause issues like addiction, suicidal thoughts, or heart problems, suggesting it is generally well-tolerated. However, some concerns exist. Young people, for instance, might experience stronger side effects, such as overheating or changes in weight, compared to adults. Considering these risks alongside the potential benefits is important. Consulting healthcare providers can help determine if joining a trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Most treatments for PTSD, such as SSRIs and psychotherapy, focus on managing symptoms over a prolonged period. However, MDMA-assisted psychotherapy is unique because it combines the psychoactive effects of MDMA with therapeutic sessions to potentially enhance emotional processing and empathy. This approach allows patients to process traumatic memories more effectively during therapy. Researchers are excited because MDMA can help break down emotional barriers, offering a promising alternative for those who haven't responded to traditional treatments.

What evidence suggests that MDMA-assisted psychotherapy might be an effective treatment for PTSD?

Research has shown that therapy using MDMA, which participants in this trial will receive, might help treat PTSD. Studies have found that MDMA can greatly reduce PTSD symptoms, even in people who haven't improved with other treatments. In one study, 71.2% of participants no longer had PTSD after 18 weeks of MDMA-assisted therapy. This treatment increases certain brain chemicals like serotonin and oxytocin, which can lift mood and strengthen emotional bonds. Overall, MDMA-assisted therapy appears promising for those with severe or hard-to-treat PTSD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescents with PTSD that hasn't improved after trying other treatments. Participants must be struggling with severe symptoms of trauma, depression, or anxiety despite previous therapy.

Inclusion Criteria

Participants may also meet criteria for a mood or anxiety disorder

Participants must meet DSM-5 criteria for current PTSD in response to a traumatic experience

I am 16 or 17 years old.

Exclusion Criteria

Participants who appear to reside within an unsupportive and/or chaotic family structure

Participants outside the specified weight range

Participants meeting DSM 5 criteria for a substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo 3-month MDMA-assisted psychotherapy, including 13 psychotherapy sessions and two MDMA sessions

12 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3 and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• MDMA

Trial Overview The study is testing whether a combination of MDMA (a drug known for its empathogenic effects) and psychotherapy can safely help teens who haven't gotten better with standard PTSD treatments.

How Is the Trial Designed?

Group I: MDMA Psychotherapy Experimental Treatment 2 Interventions

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.

MDMA is already approved in United States for the following indications:

Approved in United States as MDMA for:

• Posttraumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588940/

MDMA-assisted psychotherapy for PTSD in adolescents Trials of MDMA-AP for PTSD have found the treatment effective in reducing PTSD symptoms and promoting remission in adults [2, 34]. Still, it is not yet clear ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660711/

MDMA-Based Psychotherapy in Treatment-Resistant Post ... MDMA can reduce PTSD symptoms even in treatment-resistant cases by increasing certain neurohormones, ie, dopamine, serotonin, norepinephrine, and oxytocin.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584619301484

assisted psychotherapy for posttraumatic stress disorder: A ... MDMA-assisted psychotherapy demonstrated a high rate of clinical response (RR = 3.47, 95% CI: 1.70, 7.06), remission (RR = 2.63, 95% CI: 1.37, 5.02), with a ...

4. nature.com nature.com/articles/s41591-021-01336-3

MDMA-assisted therapy for severe PTSD: a randomized ... In summary, MDMA-assisted therapy induces rapid onset of treatment efficacy, even in those with severe PTSD, and in those with associated ...

5. ucsf.edu ucsf.edu/news/2023/09/426116/mdmas-latest-trial-results-offer-hope-for-patients-ptsd

MDMA's Latest Trial Results Offer Hope for Patients with ... By the end of the 18-week trial period, 71.2% of the people in the MDMA-assisted therapy group no longer met the diagnostic criteria for PTSD, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6984008/

The Acute Toxic and Neurotoxic Effects of 3,4 ... Acute lethality, acute hyperthermia, and acute decreases in body weight effects following MDMA administration were more pronounced in adolescent than adult ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166432819311878

The acute toxic and neurotoxic effects of 3,4 ... Despite the potential therapeutic role of MDMA for PTSD, the consequences of exposure to amphetamines have been a serious cause of concern.

8. akjournals.com akjournals.com/view/journals/2054/8/2/article-p274.xml

Critical review of 3,4-methylenedioxymethamphetamine ... At the 12-month follow-up, lower scores across measures were observed and 76% of participants no longer met diagnostic criteria for PTSD.