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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Alcohol Use Disorder (AUD), Alcohol-Related Disorders, Alcohol Use

Intervention / Treatment
-----------------
* Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
* Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
* Drug: 25 mg Diphenhydramine (5 min) + Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder Medically healthy Ability to provide consent Exclusion Criteria: Unstable medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min) | Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion<br>* Infusion<br>* Other names: Moderate Dose DMT;|
| Active Comparator: Group 2<br>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<br>* Infusion<br>* Other names: Low Dose DMT;|
| Placebo Comparator: Group 3<br>Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min) | Drug: 25 mg Diphenhydramine (5 min) + Normal Saline<br>* Infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 0 through Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | Day 0 through Day 56 |