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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are you willing to abstain from cannabis use for at least 12 weeks while you participate in the study?
Are you willing to use contraception throughout the study period?
Must not have
Have you used psychedelics in the past 2 years? e.g. LSD, MDMA, DMT, psilocybin, ayahuasca, mescaline, mushrooms, ecstasy
Have you or an immediate family member (child, sibling, parent) ever been diagnosed with Schizophrenia or Bipolar Disorder?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
The reason for this study is to see if the investigational study drug, called MM120, can help people with Anxiety compared to a placebo. A placebo is an inactive drug that looks like MM120 but does not contain any active ingredients.
Eligible Conditions
- Anxiety
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the efficacy of a single dose of MM120 versus placebo on anxiety symptoms in adults with GAD
Secondary study objectives
To evaluate the efficacy of a single dose of MM120 versus placebo on additional measures of anxiety, functioning and quality of life in adults with GAD
Study Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: MM120Experimental Treatment1 Intervention
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Group II: Arm 2: MM120Experimental Treatment1 Intervention
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Group III: Arm 3: PlaceboPlacebo Group1 Intervention
An inactive drug that looks like MM120 but does not contain any active ingredients.
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Who is running the clinical trial?
Mind Medicine, Inc.Lead Sponsor
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