Volunteering to Participate in the Trial
Purpose of the Study
This study is being conducted in Portland, Oregon, and is designed to gather information on whether the drug 3,4-Methylenedioxymethamphetamine (MDMA) combined with psychotherapy is safe and helpful for people with Social Anxiety Disorder (SAD). Each volunteer will be assigned at random (like flipping a coin) to get either MDMA with psychotherapy immediately or after a 16-week delay. Volunteers will have a 50/50 chance of being assigned to either group and both groups will receive MDMA-assisted therapy.
What is Social Anxiety Disorder (SAD)?
SAD involves fear, anxiety and avoidance of social situations that interferes with relationships, daily routines, work, school, or other activities. SAD can affect people of any race, gender, sexual orientation, age, or ethnicity. However, we also know that accessing effective treatment can be difficult, especially for people who come from disadvantaged populations or who have marginalized identities.
Common symptoms of SAD:
- Intense fear or anxiety during social situations
- Fear of situations where you might be judged negatively or are the center of attention
- Worry about embarrassing or humiliating yourself
- Avoidance of doing things or speaking to people out of fear of embarrassment
- Repeatedly thinking about your flaws or analyzing how you did after social situations are over
Psychotherapy can be helpful for many people with SAD, but we know that psychotherapy alone isn’t effective for everyone. Our study aims to examine whether adding MDMA during some therapy sessions can help make psychotherapy even more effective. The therapy we provide as part of the study is culturally sensitive, affirming, and respectful to people of diverse backgrounds. You can read more about our study team here.
How Does the Study Work?
Each volunteer will be assigned at random (like flipping a coin) to get either MDMA with psychotherapy immediately or after a 16-week delay. Volunteers will have a 50/50 chance of being assigned to either group and both groups will receive MDMA-assisted therapy.
Study Visit Overview
To make sure every potential volunteer is safely evaluated, study staff will meet with them to ask questions about their medical and psychiatric history. This is called screening. Potential participants will need to provide medical records, have blood drawn, and visit the study physician. If the volunteer is eligible for the study, they will meet with the study therapists 11 times for psychotherapy over about 3-4 months. These 11 meetings will consist of 2 day-long therapy sessions with MDMA and 9 other therapy sessions that are each about 1.5 hours long. Throughout the study, participants will complete questionnaires about how they are doing and meet with qualified researchers over video call to answer questions about their symptoms and will participate in other study assessments. At the end of the study, the study therapists and participants will meet one final time.
To date, over 1,775 people have been given MDMA in controlled research settings. There have been no documented deaths, disabilities, or addictions as a result and no serious unexpected medical issues have happened. In this study, MDMA is administered a few times over 8 weeks, unlike most medications for SAD, which are often taken daily for years.
We are seeking a range of diverse individuals for this study. If you think you may have social anxiety disorder and are interested in seeing if you are eligible to participate, please fill click on the APPLY NOW button below and fill out the screening survey. You will have a chance to ask any and all questions you may have before you would participate.
Approximate Enrollment Dates
Participant Target Enrollment
20 people between the ages of 18 and 65 years old
To Qualify You Must:
- Have social anxiety disorder
- Be in good physical health
- Be between 18 and 65 years old
- Be fluent in speaking and reading English
- Agree to be video recorded during visits with therapists
- Have a supportive relative, spouse, close friend, or other caregiver to serve as your emergency contact and support person
- Agree to all study rules and commit to all visits (which will be discussed during Screening)
- Not be pregnant, and commit to not getting pregnant during the study
- Not participate in any other interventional clinical trials during the duration of the study
- Be available for a 32-week period of time
- Be available for a full day of therapy, twice
- Be willing to remain overnight at the study site after each day-long therapy session and be driven home after