Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT06405607
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Psilocybin — DRUG
    30 mg single dose
  • Ketamine — DRUG
    0.75 mg/kg weight-based single dose

Study Details

This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.

Key Dates

Start date
Jun 12, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin Group (Arm 1)
    receives individual psychotherapy sessions plus a (30 mg) psilocybin session.
  • Active Comparator: Ketamine Group (Arm 2)
    receives individual psychotherapy sessions plus a (0.75 mg/kg) ketamine session

Primary Outcome Measure

Timeline Follow-Back for Alcohol to assess change [ Time Frame: Weekly, over the course of 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52240
Lindsay E Golden
[email protected]

Find similar trials in Iowa City, IA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Iowa Health Care· Iowa City, IA

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