The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
Medically healthy
Ability to provide consent
Disqualifiers
Unstable medical conditions
Trial design
Design model
Parallel
Treatments tested in this trial
0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
DrugInfusion
0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
DrugInfusion
25 mg Diphenhydramine (5 min) + Normal Saline
DrugInfusion
Treatment groups
63 Participants
are divided into 3 treatment groupsGroup A: Group 1Active comparator 1 intervention
Group B: Group 2Active comparator 1 intervention
Group C: Group 3Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 562
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 56Secondary outcomes
1
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 562
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 563
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 564
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 56Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov