Status:
RECRUITING
Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder
Lead Sponsor:
Dr. med. Marcus Herdener
Collaborating Sponsors:
University of Zurich
Conditions:
Alcohol Abuse/Dependence
Alcohol Use Disorder (AUD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to learn about the effects of the combination of ketamine and realtime functional magnetic resonance imaging (fMRI) neurofeedback training on the treatment of indivi...
Detailed Description
For decades, addiction research has focused predominantly on the dopaminergic system. However, preclinical research suggests that alterations of glutamatergic neurotransmission within the nucleus accu...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature
- In- and outpatients aged 18 to 65 years of all sexes.
- DSM-IV diagnosis of alcohol use disorder (mild - severe).
- Motivation to reduce or stop alcohol use
- Normal level of language comprehension (German or Swiss-German)
- Good physical health with no unstable medical conditions
- Participants of childbearing potential must use an effective and established method of contraception for the entire study duration
- Comply with the study protocol as explained by investigator
Exclusion
- History of DSM-IV severe drug dependence other than alcohol (except for caffeine or nicotine) and any opiod use disorder within two months prior to enrolment.
- Hallucinogen and ketamine use 3 months prior to study participation (including regular microdosing).
- Alcohol withdrawal symptoms at any of the treatment visits (V2 and V3) (CIWA-Ar Scale \>9).
- Current or lifetime psychotic disorders
- History of severe substance-induced psychosis
- Current or lifetime bipolar I or II disorders
- Current suicidality
- Previous suicide attempts during the last 2 years
- High risk of adverse emotional and behavioral reactions
- Unmedicated or unstable hypertension
- Severe illness (e. g. myocardial ischemia or arrythmias, severe pulmonary secretions, glaucoma, congestive heart failure or angina, significant renal or hepatic impairment)
- Acute infection (e. g. pulmonary or upper respiratory tract infection)
- Insufficient treated or uncorrected hyperthyroidism
- Severe central nervous system related traumas or disorders (e. g. stroke, cerebral trauma with loss of consciousness over more than 24h, epilepsy)
- During the study, new use or dose changes of already existing concomitant medication without prior informing the investigators.
- Taking medications that are known to modualte uridine diphosphate glucuronosyltransferase-enzyme
- Medication directly affecting glutamate signaling (e. g. anticonvulsant medication)
- Inhibitors of UGT1A9 and 1A10 should be discontinued at least five half-lives prior to the administration of ketamine.
- Monoamine oxidase and aldehyde or alcohol dehydrogenase inhibitors should be discontinued at least 5 half-lives prior to the dose of ketamine.
- Pregnancy or lactation
- Women of childbearing potential with no use of medically accepted contraceptive (e. g. condoms, contraceptive diaphragm, birth control pill, hormone injection, intrauterine device)
- BMI \< 17 or \> 35
- Allergy, hypersensitivity, or other adverse reaction to previous use of ketamine
- Contradictions to magnetic resonance imaging
- Concurrent participation in other clinical study
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06969937
Start Date
June 1 2025
End Date
December 1 2026
Last Update
December 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Psychiatric University Zurich, University of Zurich
Zurich, Switzerland, 8032