Alcohol-Related Disorders, Alcohol Use, Alcohol Use Disorder (AUD)
Conditions
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.
Interventions
DRUG0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
Infusion
DRUG0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
Infusion
DRUG25 mg Diphenhydramine (5 min) + Normal Saline
Infusion
Sponsors
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of DMT in women and men with AUD | Day 0 through Day 56 | 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. |
| The effects of DMT, plus psychotherapy, on alcohol consumption | Day 0 through Day 56 | We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The relationship between acute psychedelic effects of DMT and alcohol consumption | Day 0 through Day 56 | The Mystical Experience Questionnaire (MEQ) will be used to assess the relationship between acute psychedelic effects of DMT and alcohol consumption. |
| The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks. | Day 0 through Day 56 | 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. |
| The prosocial effects of DMT, plus psychotherapy, and changes in personality traits | Day 0 through Day 56 | 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. |
| The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma | Day 0 through Day 56 | 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. |
Countries
United States
Contacts
CONTACTAngelina Contreras
CONTACTArdavan Mohammad Aghaei
PRINCIPAL_INVESTIGATORAnahita Bassir Nia, MD
Yale University
Outcome results
None listed