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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
63
Connecticut Mental Health Center
New Haven, Connecticut, United States
RECRUITINGSafety 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.
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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