Living with Anxiety

Do you find yourself struggling with excessive or uncontrollable worry, nervousness, restlessness, or other symptoms of anxiety? You are not alone. Anxiety is the most common type of mental health issue in the United States, and up to 20% of people suffer from an anxiety disorder in any given year.

Anxiety can significantly impact all areas of your life. People with uncontrolled anxiety are more likely to suffer from depression, substance abuse, gastrointestinal disorders, and insomnia. While there are a number of medications available to treat anxiety, they may be ineffective or cause unwanted side effects. There is a significant need for new treatment options for anxiety. Researchers are actively studying new options.

About the Study

This study is evaluating an investigational oral medicine called MM-120 (LSD D-tartrate) for generalized anxiety symptoms in adults 18 to 74 years old. Researchers will compare the safety and effectiveness of four different doses of MM-120 against a matching placebo (no active ingredient) for improving symptoms of anxiety.

LSD has been previously studied in over 1,000 adults. Results from these studies indicate that LSD is relatively safe both physiologically and psychologically when taken in an appropriate therapeutic setting. Side effects are minimal, and a single dose may provide both rapid and lasting improvement in anxiety symptoms. MM-120 is considered an investigational product because it has not been approved for use outside of clinical trials

Who Can Participate?

This study may be an option for people who

Are 18 to 74 years old
Are experiencing symptoms of Generalized Anxiety
Are generally healthy
Are willing to prevent pregnancy for themselves or a partner for the duration of the study
Are able and willing to stop all medications affecting mood, as directed by the study doctor
Do not have a history of psychedelic or other illicit substance use (excluding cannabis)

There are other requirements to join this clinical trial. A study team member will help determine if this study is right for you based on all participation criteria.

What to Expect

If you are eligible and choose to take part in this study, a computer will assign you by chance to receive the study drug MM-120 at one of four different dose levels, or a matching placebo (no active ingredient). You will not know what you have been assigned to receive.

You will receive a single dose of the study drug or placebo, taken as 8 oral capsules. After you take your dose, you will be monitored by staff at the study site for at least 12 hours.

You will be enrolled in the study for about 17 weeks, including a 4-week Screening Period, 4-day Baseline and Dosing Period, and a 12-week Follow-Up Period. You will need to attend at least 9 in-clinic visits during your time in the study.

The study drug or placebo will be provided at no cost to you. Additionally, reimbursement for study-related time and travel may be available.

You can choose to leave the study at any time, for any reason. Choosing not to participate in this study will not affect your future medical care.

Why Participate?

Before a potential treatment for anxiety can be approved, it must first be tested in a series of clinical trials. Clinical trials are a type of research and an essential step in the process of developing new medications. They are not possible without the participation of volunteers.

By choosing to volunteer, you will help us learn more about the safety and effectiveness of the study drug MM-120 (LSD D-tartrate) for treating the symptoms of anxiety. The results of this study may lead to additional treatment options that could help others living with anxiety in the future.

Question 1 of 13

Are you between 18-74 years old?

Question 2 of 13

Do you experience excessive worry or tension multiple days in a week?

Question 3 of 13

Participants will be enrolled in this study for about four months. Are you willing to commit to participating in the study for this time period?

NOTE: Visits may occur during working hours.

Question 4 of 13

The study includes a single dosing day that may exceed 12 hours. Would you be able to get through this day with no access to electronic devices (phone, computers, tablets, etc.)?

Question 5 of 13

Are you willing to have 2 tablespoons of your blood drawn by needle up to 10 times over 12 weeks?

Question 6 of 13

Have you ever been diagnosed with PTSD?

Question 7 of 13

Have you or an immediate family member (child, sibling, parent) ever been diagnosed with a psychotic disorder like schizophrenia, bipolar disorder I or II, etc.)?

Question 8 of 13

Have you used psychedelics (e.g. LSD, MDMA, DMT, psilocybin, ayahuasca, mescaline, mushrooms, or ecstasy) in the past 2 years?

Question 9 of 13

Participants may not use cannabis in any form (including THC and CBD) during this study.

I am willing to discuss my cannabis use with the study team and agree not to use any form of cannabis for the duration of the study (about four or five months).

Question 10 of 13

Do you take medication for any of the following conditions?

Anxiety
Depression
Panic attacks
Trouble sleeping

Question 11 of 13

Because it is unknown how the study medicine may affect pregnancy, participants who are sexually active and able to become pregnant (or get someone pregnant) must agree to use a highly effective method of birth control to prevent pregnancy during the study.

I am willing to discuss with the study team my (or my partner's) ability to become pregnant and agree to consistently use an approved method of birth control for the duration of the study (as applicable).

Question 12 of 13

Participants will be asked about any previous and/or current recreational use of substances including cocaine, amphetamines, meth, opioids, heroin, ketamine, and psychedelics.

I am willing to discuss previous and/or current recreational drug use with the study team.

Question 13 of 13

For safety reasons, participants will not be allowed to drive themselves home after their dosing day visit.

I have a friend or family member who will be able to meet me at the study clinic and drive me home after my single dosing day.

So far - So good!

You appear to meet the pre-screening requirements for the Anxiety Research Study! However, only the research study staff can fully determine if you qualify to enroll in the study. Please enter your information below and a study coordinator will contact you soon.

Choose a Location

Please select a research site near you. If you don't see a site near you, then select "The sites listed here are not convenient for me." Study locations are being added regularly. A study representative will call you if a research site becomes available in your area.

Great Lakes Clinical Trials

Chicago, IL 60640

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Preferred Research Partners

Little Rock, AR 72211

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Pacific Neuroscience Institute

Santa Monica, CA 90404

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CNS Healthcare- Orlando

Orlando, FL 32801

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Hassman Research Institute

Berlin, NJ 08009

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iResearch Atlanta

Decatur, GA 30030

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Irvine Center for Clinical Research

Irvine, CA 92614

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The sites listed here are not convenient for me.

We're sorry, but you are not eligible at this time...

Thank you so much for your interest in the Anxiety Research Study and for answering our questions. Contact your healthcare provider if you have any medical questions. Also, please consider entering your information below to be contacted about future clinical research opportunities.