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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06070649
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Group 1
    Bolus of 0.3mg/kg/min DMT (5min) + Normal Saline infusion (60 min)
  • Active Comparator: Group 2
    Bolus of 0.2 mg/kg/min DMT (5 min) + 0.01mg/kg/min infusion (60 min)
  • Placebo Comparator: Group 3
    Bolus of 25 mg Diphenhydramine (5 min) + Normal Saline infusion (60 min)

Primary Outcome Measure

Safety and tolerability of DMT in women and men with AUD [ Time Frame: Day 0 through Day 56 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health CenterNew HavenConnecticut06519
Anahita Bassir Nia, MD
[email protected]
Anahita Bassir Nia, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Connecticut Mental Health Center· New Haven, CT

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