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

Alcohol-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06070649
• Other study ID #: 2000035937
• Secondary ID: 1R21AA030649-01A
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Angelina Contreras
• Phone: (203) 974-7525
• Email: angelina.contreras[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use
• Alcohol Use Disorder (AUD)
• Alcohol-Related Disorders
• Alcoholism

Intervention

Drug:
• 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
Infusion
• 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
Infusion
• 25 mg Diphenhydramine (5 min) + Normal Saline
Infusion

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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