Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Iowa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Weight between 50kg and 150kg
No known allergies to rescue medication
For people capable of becoming pregnant, not pregnant and using contraception
Not currently breastfeeding
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin
Drug30 mg single dose
Ketamine
Drug0.75 mg/kg weight-based single dose
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Psilocybin Group (Arm 1)Experimental treatment 1 intervention
Group B: Ketamine Group (Arm 2)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Timeline Follow-Back for Alcohol to assess change
Quantifies daily alcohol use
Time frame
Weekly, over the course of 16 weeksSecondary outcomes
1
T1rho
Measures biological changes in the brain
Time frame
Twice (before intervention, post intervention): at week 1 and week 162
Resting state fMRI
Measures biological changes in brain resting state global functional connectivity
Time frame
Twice (before intervention, post intervention):: at week 1 and week 163
EEG- signal complexity
Measures electrical signal change
Time frame
Twice (before drug administration and at peak of drug experience) during week 3Sponsors and contacts
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Source ClinicalTrials.gov