Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06969937

PHASE2

Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder

Sponsor: Dr. med. Marcus Herdener

View on ClinicalTrials.gov

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 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.

Official title: Phase II, Randomised, Placebo-controlled, Double Blind, Parallel Group, Single Centre Study Investigating Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-01

Completion Date

2026-12

Last Updated

2025-12-05

Healthy Volunteers

Conditions

Alcohol Abuse/Dependence Alcohol Use Disorder (AUD)Alcoholism

Interventions

DRUG

Ketamine

A single dose of ketamine 0.8 mg ketamine (i.v.) per kilogram bodyweight

BEHAVIORAL

Real-time fMRI Neurofeedback Training

Participants will undergo a closed-loop rt-fMRI paradigm over 25 minutes. Participants will be instructed to use strategies to downregulate cue-induced cravings. The Intensity of cues will adjust based on the participants neural activity in response to cues. This dynamic feedback mechanism allows for personalized training aimed at improving the participant's ability to manage cravings.

DRUG

Placebo

Single dose of placebo (0.9% NaCl infusion)

BEHAVIORAL

Sham Neurofeedback Training/ Ketamine

Participants get a real time neurofeedback based on a control regions' activity, which serves as a sham region and receive 0.8 mg ketamine (i.v.) per kilogram bodyweight. The use of sham-NFT allows for a rigorous assessment of the specific effects of combined rt-fMRI NFT and ketamine by controlling for non-specific factors such as expectancy effects or the therapeutic context.

Inclusion Criteria: * 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 Criteria: * 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

Locations (1)

Psychiatric University Zurich, University of Zurich

Zurich, Switzerland