search
Back to results

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

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
25 mg Diphenhydramine (5 min) + Normal Saline
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder (AUD)

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)

Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)

Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).
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.
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.

Full Information

First Posted
August 16, 2023
Last Updated
October 23, 2023
Sponsor
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT06070649
Brief Title
The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
Official Title
The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD), Alcohol-Related Disorders, Alcohol Use

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Description
Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)
Intervention Type
Drug
Intervention Name(s)
0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion
Other Intervention Name(s)
Moderate Dose DMT
Intervention Description
Infusion
Intervention Type
Drug
Intervention Name(s)
0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion
Other Intervention Name(s)
Low Dose DMT
Intervention Description
Infusion
Intervention Type
Drug
Intervention Name(s)
25 mg Diphenhydramine (5 min) + Normal Saline
Intervention Description
Infusion
Primary Outcome Measure Information:
Title
Safety and tolerability of DMT in women and men with AUD
Description
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
Title
The effects of DMT, plus psychotherapy, on alcohol consumption
Description
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
Secondary Outcome Measure Information:
Title
The relationship between acute psychedelic effects of DMT and alcohol consumption
Description
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
Title
The relationship between acute psychedelic effects of DMT and alcohol consumption
Description
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
Title
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
Description
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
Title
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
Description
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 56
Title
The long-term effects of a single dose of DMT, plus psychotherapy, on alcohol consumption over the subsequent 8 weeks.
Description
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
Title
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Description
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
Title
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Description
Prosocial effects with be assessed using the Social Connectedness Scale - Revised (SCS-R).
Time Frame
Day 0 through Day 56
Title
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Description
Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).
Time Frame
Day 0 through Day 56
Title
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
Description
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
Title
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelina Contreras
Phone
(203) 974-7525
Email
angelina.contreras@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ardavan Mohammad Aghaei
Email
ardavan.mohammadaghaei@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anahita Bassir Nia, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Bassir Nia, MD
Email
anahita.bassirnia@yale.edu
First Name & Middle Initial & Last Name & Degree
Anahita Bassir Nia, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs