MDMA-Assisted Psychotherapy for Social Anxiety Disorder

(SAMATI Trial)

Recruiting at 1 trial location

Overseen By Jason Luoma, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jason B Luoma

Must not be taking: QT prolonging drugs

Disqualifiers: Cardiovascular, Neurological, Liver disease, 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: 7

Duration: 8 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests MDMA-assisted therapy for people with severe social anxiety who haven't improved with other treatments. MDMA helps reduce fear and makes therapy more effective by making people feel more open and connected. MDMA has been studied for its potential to enhance psychotherapy, particularly in treating social anxiety disorder by improving emotional processing and therapeutic relationships.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain medications are excluded. It's best to contact the research team for more details.

What evidence supports the effectiveness of the drug MDMA for treating social anxiety disorder?

Research suggests that MDMA-assisted therapy may help improve social anxiety by enhancing motivation to connect with others, altering perceptions of social reward, and reducing feelings of shame. A small study in autistic adults showed promising results, indicating potential benefits for social anxiety. ^{1 2 3 4 5}

Is MDMA-assisted psychotherapy generally safe for humans?

MDMA-assisted psychotherapy has been studied for conditions like PTSD, and while it shows promise, there are potential adverse events. Safety data from these studies suggest that while some people benefit, there can be side effects, so it's important to weigh the risks and benefits with a healthcare provider. ^{1 3 4 6 7}

How is MDMA-assisted psychotherapy different from other treatments for social anxiety disorder?

MDMA-assisted psychotherapy is unique because it combines the drug MDMA, which can enhance social interactions and reduce negative social responses, with therapy sessions to potentially improve therapeutic relationships and memory processing, offering a novel approach compared to standard treatments. ^{1 4 7 8 9}

Research Team

Jason B Luoma, Ph.D.

Principal Investigator

Portland Psychotherapy Clinic, Research, and Training Center

Eligibility Criteria

Adults aged 18-65 with moderate-to-severe social anxiety disorder, living in Portland, OR. Participants must speak/read English, agree to recorded sessions and lifestyle changes, have a support person for post-session care, and use birth control if applicable. Stable hypertension or treated hepatitis C is okay; glaucoma patients need ophthalmologist approval.

Inclusion Criteria

Agree to have study visits recorded, including Experimental Sessions, assessments, and non-drug psychotherapy sessions

I am between 18 and 65 years old.

You give permission for your study visits to be recorded, including therapy sessions, tests, and experimental sessions.

Exclusion Criteria

Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 millimeters of Mercury [mmHg] or higher assessed on three separate occasions)

Have a marked baseline prolongation of QT/QTc interval

Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of SAD or any other psychiatric disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Sessions

Three 90-minute non-drug preparatory psychotherapy sessions

3 weeks

3 visits (in-person)

Treatment

Participants receive two MDMA-assisted therapy sessions with manualized therapy

8 weeks

2 visits (in-person) for MDMA sessions, 6 visits (in-person) for integrative sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Follow-up assessments at 2 weeks and 26 weeks post-treatment

Long-term Follow-up Extension

Participants may opt into a long-term follow-up study conducted 24 months post-treatment

Treatment Details

Interventions

• MDMA

Trial Overview The trial tests MDMA-assisted therapy's safety and effectiveness on social anxiety disorder using two experimental sessions. It measures the impact on social anxiety through the Liebowitz Social Anxiety Scale and other assessments like physiological responses and self-reports.

Participant Groups

Group I: MDMA-assisted psychotherapy Experimental Treatment 2 Interventions

Two sessions of manualized MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose 1.5 to 2 hours later. MDMA sessions are preceded by 3 non-drug preparatory psychotherapy sessions and followed by 3 integrative non-drug psychotherapy sessions.

Group II: Delayed treatment Experimental Treatment 2 Interventions

Participants randomly assigned to the delayed treatment control condition will wait 16 weeks and then receive MDMA-assisted therapy protocol described in the experimental arm of the study.

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?

Jason B Luoma

Lead Sponsor

Trials

1

Recruited

90+

Lykos Therapeutics

Collaborator

Trials

12

Recruited

330+

Oregon Research Institute Center for Evaluation Services

Collaborator

Trials

1

Recruited

90+

Multidisciplinary Association for Psychedelic Studies

Collaborator

Trials

40

Recruited

1,200+

Portland Psychotherapy Clinic, Research, and Training Center

Collaborator

Trials

1

Recruited

90+

Findings from Research

MDMA may enhance psychotherapy for social anxiety disorder by improving memory reconsolidation, which can help patients process and integrate their experiences more effectively.

The drug may also foster self-transcendent emotions like compassion and love, and strengthen the therapeutic relationship, both of which are crucial for successful treatment outcomes in disorders characterized by social disconnection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential processes of change in MDMA-Assisted therapy for social anxiety disorder: Enhanced memory reconsolidation, self-transcendence, and therapeutic relationships. Luoma, JB., Shahar, B., Kati Lear, M., et al.[2022]

A systematic review of 16 studies and a meta-analysis of 10 studies involving 168 patients suggest that MDMA, when used in conjunction with psychotherapy, shows promising efficacy in treating post-traumatic stress disorder (PTSD).

The analysis highlights both the potential benefits and adverse events associated with MDMA treatment, indicating that it may be particularly beneficial for treatment-resistant patients, thus paving the way for future drug development in psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of MDMA (3,4-Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta-Analysis. Tedesco, S., Gajaram, G., Chida, S., et al.[2021]

An estimated 0.9% of individuals aged 12 and older in the U.S. reported using ecstasy/MDMA in the past year, indicating that while use is relatively rare, it is more common among younger age groups and certain racial minorities.

Factors such as past-year use of other drugs, prescription drug misuse, nicotine dependence, and alcohol use disorder were associated with increased odds of ecstasy/MDMA use, highlighting the need for targeted prevention and harm reduction strategies for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Past Year Ecstasy/MDMA Use in the United States. Yang, KH., Kepner, W., Nijum, A., et al.[2023]

In a study involving 39 healthy adults, MDMA did not reduce physiological or subjective stress responses during a public speaking task, contrary to the hypothesis that it would dampen stress reactions.

While MDMA is known for its potential benefits in treating PTSD, this research indicates that a single dose does not moderate acute stress responses, suggesting that its therapeutic effects may depend on different conditions or contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MDMA does not alter responses to the Trier Social Stress Test in humans. Bershad, AK., Miller, MA., de Wit, H.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Potential processes of change in MDMA-Assisted therapy for social anxiety disorder: Enhanced memory reconsolidation, self-transcendence, and therapeutic relationships. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

MDMA-Assisted Therapy as a Means to Alter Affective, Cognitive, Behavioral, and Neurological Systems Underlying Social Dysfunction in Social Anxiety Disorder. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Social anxiety and MDMA-assisted therapy investigation: a novel clinical trial protocol. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of social anxiety disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of MDMA (3,4-Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta-Analysis. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Past Year Ecstasy/MDMA Use in the United States. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

MDMA does not alter responses to the Trier Social Stress Test in humans. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

(+/-)-3,4-methylenedioxymethamphetamine (MDMA, 'Ecstasy') increases social interaction in rats. [2019]