Actively Recruiting
Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder
Led by Dr. med. Marcus Herdener · Updated on 2025-12-05
75
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
D
Dr. med. Marcus Herdener
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 individuals with alcohol use disorder (AUD). The main questions the investigators aim to answer are: * Can the investigators observe a positive, significant therapeutic effect by comparing changes in alcohol use via i) mean alcohol use per day, ii) heavy drinking days one month after the last treatment intervention? * Are changes in glutamatergic neurotransmission in the nucleus accumbens related to cue-induced cravings in individuals with AUD? * Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens? Participants will be given ketamine or placebo and real-time fMRI neurofeedback (rt-fMRI NFT) or sham rt-fMRI NFT. The investigators will compare three intervention groups to investigate the effects of the stand-alone effects as well as potential synergies between the combination of pharmacological and non-pharmacological intervention.
CONDITIONS
Official Title
Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Adults aged 18 to 65 years, all sexes
- Diagnosis of alcohol use disorder (mild to severe) based on DSM-IV
- Motivation to reduce or stop alcohol use
- Normal proficiency in German or Swiss-German
- Good physical health with no unstable medical conditions
- Use of effective contraception for participants of childbearing potential throughout the study
- Willingness to follow the study protocol as explained by investigators
You will not qualify if you...
- Severe drug dependence (except caffeine or nicotine) or opioid use disorder within 2 months before enrollment
- Use of hallucinogens or ketamine within 3 months prior to participation
- Alcohol withdrawal symptoms with CIWA-Ar score over 9 during treatment visits
- Current or past psychotic disorders, severe substance-induced psychosis, bipolar I or II disorders
- Current suicidality or suicide attempts within last 2 years
- High risk of adverse emotional or behavioral reactions
- Unmedicated or unstable high blood pressure
- Severe illnesses such as heart problems, glaucoma, kidney or liver impairment
- Acute infections like respiratory tract infections
- Untreated or poorly treated hyperthyroidism
- Severe central nervous system trauma or disorders such as stroke, epilepsy
- Changes to existing medications without informing investigators during the study
- Use of medications affecting specific enzymes or glutamate signaling
- Pregnancy or lactation
- Women of childbearing potential not using medically accepted contraception
- Body mass index less than 17 or greater than 35
- Allergies or adverse reactions to ketamine
- Contraindications to MRI
- Participation in another clinical study concurrently
AI-Screening
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Trial Site Locations
Total: 1 location
1
Psychiatric University Zurich, University of Zurich
Zurich, Switzerland, 8032
Actively Recruiting
Research Team
M
Marcus Herdener, PD Dr. med.
CONTACT
E
Etna Engeli, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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