MDMA-Assisted Psychotherapy for PTSD

(VALLMDMA_001 Trial)

Overseen By Angela J Hawley, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Loma Linda Health Care System

Must not be taking: Anticonvulsants, Psychoactive medications

Disqualifiers: Psychotic disorder, Bipolar, Cardiovascular, 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

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MDMA (3,4-methylenedioxymethamphetamine), used alongside therapy, can reduce PTSD (post-traumatic stress disorder) symptoms in military veterans. Participants take MDMA during three therapy sessions over 12 weeks to determine its effectiveness in easing combat-related PTSD that hasn't improved with other treatments. The trial seeks U.S. military veterans who have experienced combat-related PTSD within the last six months and are currently receiving VA healthcare. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to groundbreaking PTSD treatment advancements.

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

Yes, you will need to stop taking any psychiatric medications during the study. If you're currently on psychoactive medications, you'll need to undergo a medically-supervised withdrawal before participating. You must also refrain from starting any new medications during the study, except for certain approved ones.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that MDMA-assisted therapy can be safely administered to people with PTSD. Studies have found that MDMA, when used in therapy, is usually well-tolerated. For instance, one study showed it reduced PTSD symptoms and helped individuals with moderate to severe PTSD function better in their daily lives.

Another review of MDMA-assisted therapy confirmed its safety and effectiveness, even for those whose PTSD hasn't improved with other treatments. This is because MDMA increases certain brain chemicals that help reduce PTSD symptoms.

While researchers continue to study MDMA, these findings suggest it can be safely used with therapy for PTSD, especially for those who haven't found relief with other treatments. ^{1 2 3 4 5}

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

Researchers are excited about MDMA-assisted psychotherapy for PTSD because it offers a unique approach compared to standard treatments like SSRIs and traditional talk therapy. Unlike typical medications that primarily target neurotransmitters, MDMA works by enhancing emotional processing and reducing fear responses, potentially allowing patients to engage more deeply in therapy. This treatment could lead to significant improvements in a shorter time frame, providing hope for those who don’t respond well to current options.

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

Research shows that using MDMA with therapy may help treat PTSD (post-traumatic stress disorder). Studies have found that MDMA, when combined with therapy, greatly reduces PTSD symptoms. In one study, 71.2% of participants no longer had PTSD after treatment. Another study showed that many patients experienced fewer symptoms and felt much better. Overall, these findings suggest that MDMA could be an effective treatment for PTSD when used with therapy. Participants in this trial will receive MDMA in an open-label format, with specific dosing during experimental sessions. ^{2 6 7 8 9}

Who Is on the Research Team?

Shannon Remick, MD

Principal Investigator

Staff Psychiatrist

Are You a Good Fit for This Trial?

This trial is for US military veterans aged 18-55 with combat-related PTSD that hasn't improved after treatment, enrolled in VA healthcare. They must be generally healthy, not on psychiatric meds (or willing to stop them safely), and agree to avoid alcohol before sessions and certain medications during the study. Pregnant women or those at serious suicide risk are excluded.

Inclusion Criteria

Are willing to follow restrictions and guidelines concerning medications, consumption of food, beverages, alcohol, nicotine, or illicit substances

Must agree to inform the investigators within 48 hours of any medical conditions and procedures

I am generally healthy with no major health issues.

Exclusion Criteria

Lack a stable living situation or supportive system

Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist

I do not have severe health issues like heart, lung, liver diseases, or immune problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preparatory Psychotherapy

Three preparatory psychotherapy sessions spaced approximately one week apart

3 weeks

3 visits (in-person)

Experimental Treatment

Three single-dose MDMA-assisted psychotherapy sessions with integrative follow-up sessions

12 weeks

3 experimental sessions, 9 integrative follow-up sessions (in-person)

Primary Endpoint Assessment

Assessment of primary endpoint 2 months after the last experimental session

2 months

1 visit (in-person)

Long-term Follow-up

Assessment of long-term effects 12 months after the last MDMA session

12 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 3,4-methylenedioxymethamphetamine (MDMA)

Trial Overview The trial tests MDMA-assisted psychotherapy's effectiveness for veterans with refractory PTSD over a 12-week period, including three single-dose sessions paired with therapy. The main goal is symptom reduction or remission measured by the Clinician-Administered PTSD Scale (CAPS-5).

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Loma Linda Health Care System

Lead Sponsor

Trials

10

Recruited

770+

Lykos Therapeutics

Collaborator

Trials

12

Recruited

330+

Multidisciplinary Association for Psychedelic Studies

Collaborator

Trials

40

Recruited

1,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34150406/

A Systematic Review and Meta-Analysis Findings show promising evidence for the potential therapeutic use of MDMA alongside psychotherapy in the treatment of PTSD.

2. nature.com nature.com/articles/s41591-023-02565-4

MDMA-assisted therapy for moderate to severe PTSD These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11924292/

assisted psychotherapy in post-traumatic stress disorder: An ... Meta-analyses reported substantial benefits of MDMA-assisted psychotherapy in improving post-traumatic stress disorder symptoms.

4. 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 ...

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/PMC3122379/

the first randomized controlled pilot study MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124003287

The efficacy and safety of MDMA-assisted psychotherapy ... This study aimed to systematically review and demonstrate the efficacy and safety of MDMA-assisted psychotherapy for the treatment of PTSD.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00353938

Study Details | NCT00353938 | Study of 3,4- ... This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying ...

9. 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.