MDMA-Assisted CBT for Obsessive-Compulsive Disorder

(MDMA-CBT4OCD Trial)

Overseen By Pavithra Mukunda, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Carolyn Rodriguez

Must not be taking: Psychotropic medications

Disqualifiers: Pregnancy, Underweight, 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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating obsessive-compulsive disorder (OCD) by combining cognitive behavioral therapy (CBT) with MDMA (a psychoactive drug also known as Ecstasy or Molly) or methamphetamine. Researchers aim to determine if these substances can enhance the effectiveness and safety of CBT for people with OCD. The trial may suit those diagnosed with OCD who have not found success with other treatments and are willing to pause medication and other therapies during the study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in OCD treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking psychotropic medications (drugs that affect your mood, thoughts, or behavior) at least 1 month before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MDMA has been used safely in other studies, and participants usually handle it well. Most side effects are mild, such as nausea or sweating, while serious issues are rare. MDMA is also being studied for PTSD (post-traumatic stress disorder), and safety results from those studies have been promising.

In contrast, studies indicate that methamphetamine can be more challenging. Some people might experience a faster heartbeat or anxiety. Although these effects are usually not severe, methamphetamine requires careful monitoring because it is a stimulant.

Both treatments have been used in controlled settings with medical supervision, which helps manage any issues that might arise. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Obsessive-Compulsive Disorder (OCD), which typically include selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) alone, MDMA-assisted CBT introduces a new approach by incorporating MDMA to potentially enhance the therapeutic effects of CBT. MDMA, known for its ability to increase feelings of openness and emotional connection, might help patients engage more deeply in therapy sessions, potentially accelerating progress and improving outcomes. Researchers are excited about this innovative combination because it offers a unique mechanism of action that could provide faster and more profound relief for those struggling with OCD, compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for OCD?

This trial will compare MDMA-assisted cognitive behavioral therapy (CBT) with methamphetamine-assisted CBT for treating obsessive-compulsive disorder (OCD). Studies have shown that MDMA therapy can reduce symptoms of PTSD, depression, and anxiety in some individuals. MDMA enhances therapy sessions by increasing feelings of trust and openness, encouraging more open communication. In a small study, MDMA combined with therapy led to significant improvements in PTSD and other mental health issues, suggesting it might also enhance CBT's effectiveness for OCD, a common OCD treatment.

For the methamphetamine-assisted CBT arm, less direct evidence supports its effectiveness for OCD. Methamphetamine is known to increase focus and energy, potentially aiding engagement in therapy sessions. However, its use in treatment settings is less established compared to MDMA. More research is needed to understand its impact when combined with CBT for OCD. ^{1 2 3 6 7}

Who Is on the Research Team?

Carolyn Rodriguez, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults fluent in the local language who can swallow pills and have been diagnosed with OCD, scoring at least 16 on the YBOCS scale. Participants must not be on psychotropic meds for a month before joining, should have tried and failed one standard treatment, and agree to lifestyle changes like fasting before sessions.

Inclusion Criteria

Able to swallow pills

I can fluently speak and read the main language used at the study site.

I have been diagnosed with OCD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MDMA-assisted or methamphetamine-assisted cognitive behavioral therapy

2 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy (CBT)
• MDMA

Trial Overview The study is testing if taking MDMA along with Cognitive Behavioral Therapy (CBT) helps people with OCD. It looks at how safe this combination is and whether it might work better than current treatments.

How Is the Trial Designed?

Group I: MDMA-assisted cognitive behavioral therapy Experimental Treatment 2 Interventions

Administration of 80mg MDMA HCl (with a supplemental dose offered 1.5 to 2 hours later of 40 mg MDMA HCl) in combination with cognitive behavioral therapy (CBT).

Group II: Methamphetamine-assisted cognitive behavioral therapy Active Control 2 Interventions

Administration of 10mg methamphetamine (with a supplemental dose offered 1.5 to 2 hours later of 5 mg methamphetamine) in combination with cognitive behavioral therapy (CBT).

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Who Is Running the Clinical Trial?

Carolyn Rodriguez

Lead Sponsor

Trials

2

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05783817

MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study) The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive ...

2. stanfordhealthcare.org stanfordhealthcare.org/trials/m/NCT05783817.html

MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study) The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive ...

3. trialx.com trialx.com/clinical-trials/listings/307746/mdma-assisted-cbt-for-ocd-mdma-cbt4ocd-study/?&geo_lat=37.4529598&geo_lng=-122.1817252&radius=10&place=Menlo%20Park&user_country=United%20States

MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study) The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive ...

4. med.stanford.edu med.stanford.edu/sleepdivision/research/clinicaltrials/results?ctid=NCT05783817&conditionId=&serviceLineId=&condition=&alpha=m

MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study) The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7748057/

MDMA-facilitated cognitive-behavioural conjoint therapy for ... MDMA was combined with cognitive-behavioural conjoint therapy for PTSD in six couples revealing significant improvements in PTSD, depression, sleep, emotion ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05783817/

Trial | NCT05783817 The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with obsessive-compulsive ...

7. withpower.com withpower.com/trial/phase-2-compulsive-personality-disorder-11-2023-74fb1

MDMA-Assisted CBT for Obsessive-Compulsive Disorder The study assesses the safety and preliminary effectiveness of MDMA-assisted cognitive behavioral therapy in participants diagnosed with ...