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RecruitingPhase 2

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

NCT06969937 · Nektar · Dr. med. Marcus Herdener

Recruiting
Status
Accepting participants
Phase 2
Phase
75
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in mean alcohol use per day

    Measured over Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).

  • Change in heavy drinking days

    Measured over Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Psychiatric University Zurich, University of ZurichZurichSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06969937 on ClinicalTrials.gov →

Last updated in the registry 2025-12-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits