Alcohol Use Disorder (AUD)Phase 1NCT06070649
The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
A Phase 1 study testing 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion, 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion and 25 mg Diphenhydramine (5 min) + Normal Saline in people with Alcohol Use Disorder (AUD) and Alcohol-Related Disorders, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcohol-Related Disorders, Alcohol Use
- What is being tested?
- 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion, 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion and 25 mg Diphenhydramine (5 min) + Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2025to 1 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
- Medically healthy
- Ability to provide consent
Who cannot join
- Unstable medical conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ardavan Mohammad Aghaei contact
United States1 site, 1 recruiting
- Recruiting
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Anahita Bassir Nia, MD, anahita.bassirnia@yale.edu
Anahita Bassir Nia, MD
About this study
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.
Read the 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.
- Being tested
- 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
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3mg/kg/min Dimethyltryptamine + Normal Saline infusionDrug
Also called Moderate Dose DMT
Infusion
0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusionDrug
Also called Low Dose DMT
Infusion
25 mg Diphenhydramine (5 min) + Normal SalineDrug
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min) Receives: 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) Receives: 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) Receives: Drug: 25 mg Diphenhydramine (5 min) + Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 through Day 56
Secondary outcomes (10)
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.
Measured: Day 0 through Day 56
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Day 0 through Day 56
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.
Measured: Day 0 through Day 56
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).
Measured: Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Prosocial effects with be assessed using the Mindful Attention Awareness Scale (MAAS).
Measured: Day 0 through Day 56
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.
Measured: Day 0 through Day 56
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.
Measured: Day 0 through Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start4 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anahita Bassir Nia, Yale University
- Investigators
- Anahita Bassir Nia, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070649
- Sponsor's protocol ID
- 2000035937
- Other IDs
- 1R21AA030649-01A1
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)
- ClinicalTrials.gov ID
- NCT06070649
- Acronym / sponsor ID
- 2000035937
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusionBolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min) |
| Group 2 | Active comparator | Drug: 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusionBolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min) |
| Group 3 | Placebo comparator | Drug: 25 mg Diphenhydramine (5 min) + Normal SalineBolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder
- Medically healthy
- Ability to provide consent
Key exclusion criteria (1 listed)
- Unstable medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusionAlso: Moderate Dose DMTInfusion | Drug | Group 1 |
| 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusionAlso: Low Dose DMTInfusion | Drug | Group 2 |
| 25 mg Diphenhydramine (5 min) + Normal SalineInfusion | Drug | Group 3 |
Primary outcome
Safety and tolerability of DMT in women and men with AUD
Time frame: 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
Time frame: Day 0 through Day 56
We will assess the desire of participants to drink alcohol in an experimental setting using the Alcohol Drinking Paradigm.
10 secondary outcomes
The relationship between acute psychedelic effects of DMT and alcohol consumption
Time frame: Day 0 through Day 56
The relationship between acute psychedelic effects of DMT and alcohol consumption
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Time frame: Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Time frame: Day 0 through Day 56
The prosocial effects of DMT, plus psychotherapy, and changes in personality traits
Time frame: Day 0 through Day 56
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
Time frame: Day 0 through Day 56
The relationship between the intensity of subjective psychedelic experience with lifetime history of chronic stress and trauma
Time frame: Day 0 through Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ardavan Mohammad Aghaei contact
Anahita Bassir Nia, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.3mg/kg/min Dimethyltryptamine + Normal Saline infusion, 0.2 mg/kg/min + Dimethyltryptamine 0.01mg/kg/min infusion and 25 mg Diphenhydramine (5 min) + Normal Saline in people with Alcohol Use Disorder (AUD) and Alcohol-Related Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelina Contreras ((203) 974-7525, angelina.contreras@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of DMT in women and men with AUD (time frame: Day 0 through Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.