The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

This study is a phase one, placebo-controlled, randomized, double blind, clinical trial to investigate the safety, tolerability and efficacy of the psychedelic dimethyltryptamine (DMT), in addition to a short course of psychotherapy on Alcohol Use Disorder (AUD). For more information, please contact study coordinator: Angelina Contreras, abn.lab@yale.edu, 475-441-4190.

Key Inclusion Criteria

• Male and Females, aged between 21 and 65 years (inclusive)

• In good general health as evidenced by medical history

• Diagnosed with alcohol use disorder based on DSM5 moderate to severe criteria

Key Exclusion Criteria

• Any current acute major medical condition that may preclude safe participation in the trial (e.g., seizure disorder, significantly impaired liver function determined based on AST or ALT > 3 times normal limits, coronary artery disease, heart failure, or uncontrolled hypertension at screening)
• Diagnosis of major psychiatric disorders (e.g., lifetime schizophrenia, lifetime schizoaffective disorder, lifetime bipolar disorder, current suicidality or history of medically serious suicide attempt)

• Seeking treatment for AUD; If a participant seeks treatment after the date of consent through the day of the alcohol paradigm, they will be withdrawn from the study procedures. This will occur because they will be given alcohol as participants in this research.

• Women with a positive pregnancy test or women who are lactating

• Allergy or hypersensitivity to DMT or diphenhydramine

• Current hypotension or history of hypotensive episodes
• Preexisting valvopathy or pulmonary hypertension
• Have implanted or embedded metal objects or fragments/heart pacemaker in the head
  or body that would present a risk during the MRI scanning procedure