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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
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
SAMATI Trial Summary
This trial is testing whether MDMA can help people with social anxiety disorder by measuring how it affects symptoms, function, and psychiatric symptoms.
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.Check my eligibility
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.See study design
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.
SAMATI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I am between 18 and 65 years old.
Select...
I can swallow pills.
SAMATI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, primary outcome (2 weeks after final integration session)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, primary outcome (2 weeks after final integration session)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Secondary outcome measures
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 moreSAMATI 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
2001
Completed Phase 2
~390
Psychotherapy
2020
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
Lykos TherapeuticsOTHER
41 Previous Clinical Trials
1,549 Total Patients Enrolled
Jason B LuomaLead Sponsor
Oregon Research Institute Center for Evaluation ServicesUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I am unable to understand or sign the consent form.You give permission for your study visits to be recorded, including therapy sessions, tests, and experimental sessions.If you are a woman who can become pregnant, you need to have a negative pregnancy test before and during the study. You also need to agree to use effective birth control for at least 10 days after the study.I do not have major health issues that could make MDMA treatment risky, except stable hypothyroidism.My high blood pressure is well-managed with medication.You currently have social anxiety disorder (SAD) with the generalized subtype, as defined by the DSM-5.I may have hepatitis C but it has been checked and treated if necessary.I am not taking any medications that are not allowed in the study.I weigh less than 48 kg.I have had low sodium levels or very high body temperature in the past.I can swallow pills.You can speak and read English well.You must tell the researchers within 2 days if you have any medical issues or procedures done.You need to give the investigators a name and phone number of someone who can be contacted in case you become unreachable or have suicidal thoughts.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).You need to have someone with you overnight after the experimental sessions, and you should be able to identify that person.You must reside in Portland, Oregon or the surrounding area.I can swallow pills.I am between 18 and 65 years old.I have symptoms caused by liver problems.I am willing to change my lifestyle as required.I need medications that may affect my heart's rhythm during the study.
Research Study Groups:
This trial has the following groups:- Group 1: MDMA-assisted psychotherapy
- Group 2: Delayed treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Social Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05138068 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people who are over 25 years old participate in this research project?
"Eligibility criteria for this trial includes being between 18-65 years old."
Answered by AI
How many people are in this clinical trial at most?
"That is correct, the trial is still open and currently looking for 20 individuals from a single location."
Answered by AI
Has the FDA cleared psychotherapy as an effective treatment?
"Psychotherapy received a safety score of 2 because, while there is some evidence affirming its safety, there is no data to support its efficacy."
Answered by AI
Are there any available vacancies for this clinical trial?
"Yes, this clinical trial is still looking for patients. The listing on clinicaltrials.gov says that the trial was first posted on 4/13/2022 and last updated on 6/20/2022."
Answered by AI
Who would be an eligible candidate for this test?
"This clinical trial is enrolling 20 participants with anxiety disorders who meet the following criteria: they must be between the ages of 18 and 65, live in the Portland, OR area, be fluent in speaking and reading English, be able to swallow pills, agree to have study visits recorded (including experimental sessions), agree to inform investigators of any medical conditions or procedures within 48 hours, if able to become pregnant must have a negative pregnancy test at entry and before each experimental session and agree to use birth control for 10 days after the last experimental session, agree to necessary lifestyle modifications, be able to identify a support person who can stay with them"
Answered by AI
Who else is applying?
What state do they live in?
Other
Washington
California
Oregon
How old are they?
18 - 65
What site did they apply to?
Portland Psychotherapy
Portland Psychotherapy Clinic, Research, & Training Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
I have had severe social anxiety my whole life and it honestly feels like it’s ruining my life sometimes with all the missed opportunities and inability to take part necessary social interactions, particularly via phone call.
PatientReceived 1 prior treatment
I would like to be able to go in to a crowd of people and not I have to leave because I can’t handle the crowd. I’ve tried depression medicine. I’ve tried therapy and I’ve even tried to help having friends help me and it just doesn’t work.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
So how long does this screening last? How long is the trial for and what does it take to be included in the trial what is required of me?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Portland Psychotherapy Clinic, Research, & Training Center: < 48 hours
Average response time
- < 2 Days
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