Mind Medicine Study MMED008

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.

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.

The study involves the following in person activities over a 17 week period:

• includes a 4-week screening period
• includes a 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.
• You will receive compensation for your time
• and travel. There is no cost to participate in this study.

• The study’s therapy and most if not all procedures are at no cost to the participant. Some participant’s insurance may be charged for some assessment procedures.
• 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.
• All visits take place in person at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.
• Study will include questionnaires and medical tests including blood tests.

• Antidepressants will need to be discontinued as well as other possible medications while participating in the study; however, participants MUST NOT discontinue ANY medication until after enrollment and with the study physician’s approval. Study physician will consult with patients’ providers.
• To maintain safety of participants, all participants will be screened for psychological factors such as a history of psychosis and medical factors such as cardiovascular issues, which could preclude participation in the study.
• Participants should not be pregnant, nursing or planning a pregnancy, and must be using a highly effective method of birth control.
• Risks to participation will be reviewed extensively during the screening and informed consent process.