NCT06070649

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
3mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

August 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

August 16, 2023

Last Update Submit

April 26, 2026

Conditions

Alcohol Use Disorder (AUD)Alcohol UseAlcohol-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • The relationship between acute psychedelic effects of DMT and alcohol consumption

    Day 0 through Day 56

  • The relationship between acute psychedelic effects of DMT and alcohol consumption

    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.

    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.

    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.

    Day 0 through Day 56

  • +5 more secondary outcomes

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion

Group 2

ACTIVE COMPARATOR

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

Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion

Group 3

PLACEBO COMPARATOR

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

Drug: 25 mg Diphenhydramine (5 min) + Normal Saline

Interventions

0.3mg/kg/min Dimethyltryptamine + Normal Saline infusionDRUG

Infusion

Also known as: Moderate Dose DMT
Group 1
0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusionDRUG

Infusion

Also known as: Low Dose DMT
Group 2
25 mg Diphenhydramine (5 min) + Normal SalineDRUG

Infusion

Group 3

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
  • Medically healthy
  • Ability to provide consent

You may not qualify if:

  • Unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismAlcohol-Related DisordersAlcohol Drinking

Interventions

N,N-DimethyltryptamineDiphenhydramineSaline Solution

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

TryptaminesBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthylaminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Anahita Bassir Nia, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelina Contreras

CONTACT

(203) 974-7525angelina.contreras@yale.edu

Ardavan Mohammad Aghaei

CONTACT

ardavan.mohammadaghaei@yale.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

August 16, 2023

First Posted

October 6, 2023

Study Start

August 4, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

US(1)