A Phase 1 interventional study of 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion and 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion in Alcohol Use Disorder (AUD), Alcohol-Related Disorders and Alcohol Use, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Yale University · Phase 1, Interventional, and Other
This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.
This study is a 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). The investigators hypothesize that relative to control (0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion plus psychotherapy), a single psychedelic dose of DMT (plus psychotherapy) in individuals with AUD will 1) be safe and 2) well-tolerated, and 3) reduce alcohol consumption measured in the laboratory the day after, and over the following 8 weeks.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 63 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)
Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)
Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)
Drug: 25 mg Diphenhydramine (5 min) + Normal Saline
Infusion
Also known as: Moderate Dose DMT
Infusion
Also known as: Low Dose DMT
Infusion
Safety and tolerability of DMT in women and men with AUD
Systematic Assessment for Treatment Emergent Effects (SAFTEE) and MedDRA will be used weekly for 8 weeks to assess safety and tolerability of DMT in women and men with AUD.
Time frame: Day 0 through Day 56
The effects of DMT, plus psychotherapy, on alcohol consumption
We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm.
Time frame: Day 0 through Day 56
The relationship between acute psychedelic effects of DMT and alcohol consumption
The Mystical Experience Questionnaire (MEQ) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption.
Time frame: Day 0 through Day 56
The relationship between acute psychedelic effects of DMT and alcohol consumption
The Ego-Dissolution Inventory (EDI) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption.
Time frame: Day 0 through Day 56
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
The Timeline Followback (TLFB) approach will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.
Time frame: Day 0 through Day 56
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.
Time frame: Day 0 through Day 56
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
Substance use disorder behaviors and risks with the Brief Addiction Monitor (BAM) will be used to assess the long-term effects of a single dose of DMT, plus psychotherapy on alcohol consumption.
Time frame: Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Prosocial effects with be assessed using the Prosocial Personality Battery (PSP). The scale consists of 56 total items and uses a Likert-type scale with 5 answer-choices.
Time frame: Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Prosocial effects with be assessed using the Social Connectedness Scale - Revised (SCS-R).
Time frame: Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).
Time frame: Day 0 through Day 56
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
The Life Events Checklist (LEC) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma.
Time frame: Day 0 through Day 56
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
The Childhood Trauma Questionnaire (CTQ-SF) will be used to assess the relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma.
Time frame: Day 0 through Day 56
Started Aug 2025 (actual). Primary completion is estimated for Aug 2027, 23 months after the start.
Of 63 non-industry phase 1 interventional studies under Alcoholism, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's planned 23 months is below that.
Counting every sponsor, half of 75 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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