What is the mechanism of action of this treatment?

Common treatments for Social Anxiety Disorder (SAD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SSRIs increase serotonin levels by inhibiting its reuptake into neurons, improving mood and reducing anxiety. SNRIs work similarly but also increase norepinephrine levels, further enhancing mood and reducing anxiety. These treatments are important for SAD patients as they modulate neurotransmitter systems involved in fear and anxiety, improving social interactions and reducing avoidance behaviors.

What side effects are associated with this type of intervention?

Common treatments for Social Anxiety Disorder (SAD) that affect serotonin, norepinephrine, and dopamine levels include SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors). Known side effects of SSRIs and SNRIs can include nausea, headache, insomnia, sexual dysfunction, and increased anxiety initially. MDMA-assisted therapy, which is being studied for SAD, may cause side effects such as increased heart rate, blood pressure, anxiety, jaw clenching, and dehydration. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Social Anxiety Disorder, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as paroxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. These medications increase serotonin levels in the brain, which can help reduce anxiety and improve mood. While MDMA-assisted therapy is not yet FDA-approved, it is being studied for its potential to facilitate emotional processing and reduce fear responses by releasing serotonin, norepinephrine, and dopamine.

What other types of research exist?

Promising, novel alternatives to MDMA-assisted therapy for Social Anxiety Disorder patients in 2024 include SSRIs (Selective Serotonin Reuptake Inhibitors), psilocybin-assisted therapy, and Cognitive-Behavioral Therapy (CBT).

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Psychedelic

MDMA-Assisted Psychotherapy for Social Anxiety Disorder (SAMATI Trial)

Phase 2

Waitlist Available

Led By Jason B Luoma, Ph.D.

Research Sponsored by Jason B Luoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are between the ages of 18 and 65 years old.

Are between the ages of 18 and 65 years old

Must not have

Are not able to give adequate informed consent

Require certain excluded medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, primary outcome (2 weeks after final integration session), follow up (26 weeks after primary outcome)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of MDMA may include increased heart rate, high blood pressure, hyperthermia (overheating), hyponatremia (low sodium levels), sleep issues, lack of appetite, strong emotions during therapy sessions or potential psychological distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am between 18 and 65 years old.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign the consent form.

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I am not taking any medications that are not allowed in the study.

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I need medications that may affect my heart's rhythm during the study.

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I have symptoms caused by liver problems.

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I have had low sodium levels or very high body temperature in the past.

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I weigh less than 48 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, primary outcome (2 weeks after final integration session), follow up (26-weeks after primary outcome)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, primary outcome (2 weeks after final integration session), follow up (26-weeks after primary outcome)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, primary outcome (2 weeks after final integration session), follow up (26-weeks after primary outcome) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Secondary study objectives

Evaluate change in acceptance of self-conscious emotions as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Acceptance of Shame and Embarrassment Scale (ASES) scores from pre- to post-treatment.

Evaluate change in internalized shame as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Internalized Shame Scale (ISS) scores from pre- to post-treatment.

Evaluate change in self-compassion as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Self-Compassion Scale scores from pre- to post-treatment.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MDMA-assisted psychotherapyExperimental Treatment2 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 treatmentExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MDMA

2023

Completed Phase 2

~420

Psychotherapy

2014

Completed Phase 3

~3440

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Social Anxiety Disorder (SAD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SSRIs increase serotonin levels by inhibiting its reuptake into neurons, improving mood and reducing anxiety. SNRIs work similarly but also increase norepinephrine levels, further enhancing mood and reducing anxiety. These treatments are important for SAD patients as they modulate neurotransmitter systems involved in fear and anxiety, improving social interactions and reducing avoidance behaviors.

Sensitization to the prosocial effects of 3,4-methylenedioxymethamphetamine (MDMA).Effects of MDMA and Intranasal oxytocin on social and emotional processing.The neuropharmacology of prolactin secretion elicited by 3,4-methylenedioxymethamphetamine ("ecstasy"): a concurrent microdialysis and plasma analysis study.