Alcohol Abuse/DependencePhase 2NektarNCT06969937
Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder
A Phase 2 study testing Ketamine and Real-time fMRI Neurofeedback Training in people with Alcohol Abuse/Dependence and Alcohol Use Disorder (AUD), run by Dr. med. Marcus Herdener at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse/Dependence, Alcohol Use Disorder (AUD), Alcoholism
- What is being tested?
- Ketamine and Real-time fMRI Neurofeedback Training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatric University Zurich, University of Zurich
Zurich, 8032
About this study
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
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?
Read more
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.
Read the 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 accumbens (NAcc) are crucial for cue-induced drug-seeking behavior, at least in animal models of addiction (Kalivas, 2009). In line with this, three randomized controlled trials have been conducted exploring ketamine as a treatment for alcohol use disorder (AUD) or harmful drinking, each combining ketamine with either memory retrieval destabilization procedures or psychological therapy (Dakwar et al., 2020a; Das et al., 2019a; Grabski et al., 2022a). While ketamine consistently reduced alcohol use in these studies, the variability in treatment responses highlights the need for further investigation into the role of the glutamate system in AUD as well as optimal treatment approaches that maximize safety and efficacy for patients.
Given the significant need to advance both mechanistic and clinical understanding of AUD, this study aims to: (1) explore the role of glutamatergic neurotransmission in AUD; (2) determine whether ketamine can modulate potentially pathophysiological altered glutamate neurotransmission, and how such modulation may be influenced by ketamine metabolism ; and (3) optimize ketamine as a treatment for AUD by leveraging synergies between the additional biological mechanism of action of ketamine (i.e., induced neuroplasticity) and a targeted non-pharmacological neuromodulatory intervention, such as neurofeedback training (NFT), to maximize clinical outcomes.
To evaluate both the mechanistic and therapeutic effects of a single ketamine infusion and rt-fMRI NFT as well as their combined application on AUD, we will assess glutamatergic signalling in the NAcc, changes in neuroplasticity via BDNF, inter-individual differences in the metabolism of ketamine, and clinical symptoms in individuals with AUD.
Therefore, in this randomized, placebo-controlled, double blind, parallel group, single centre study we investigate the extend to which a single administration of ketamine and neurofeedback training, as well as the combination of the two interventions can restore neurobiological changes related to alcoholism and what effect this new treatment method has on the symptoms of AUD.
- Being tested
- Ketamine, Real-time fMRI Neurofeedback Training, Placebo, Sham Neurofeedback Training/ Ketamine
- Keywords
- Alcohol Use Disorder, Alcoholism, Alcohol Dependence, Ketamine, Glutamate, Placebo-controlled, Neurofeedback Training, Realtime fMRI, Therapeutic effects, Mechanistic effects
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
A single dose of ketamine 0.8 mg ketamine (i.v.) per kilogram bodyweight
Real-time fMRI Neurofeedback TrainingBehavioural
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.
PlaceboDrug
Single dose of placebo (0.9% NaCl infusion)
Sham Neurofeedback Training/ KetamineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| rt-fMRI NFT / Ketamine | Experimental | Participants get real time neurofeedback based on an experimental regions' activity and receive 0.8 mg ketamine (i.v.) per kilogram bodyweight. Receives: Drug: Ketamine; Behavioral: Real-time fMRI Neurofeedback Training |
| sham rt-fMRI NFT / Ketamine | Experimental | 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. Receives: Drug: Ketamine; Behavioral: Sham Neurofeedback Training/ Ketamine |
| rt-fMRI NFT / Placebo | Experimental | Participants get real time neurofeedback based on an control regions' activity and receive a 0.9% NaCL infusion (placebo). Receives: Behavioral: Real-time fMRI Neurofeedback Training; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean alcohol use per day
Change in mean alcohol use per day. Alcohol use is measured via a combination of the digital app and the Timeline Follow-Back Questionnaire.
Measured: Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).
Change in heavy drinking days
Change in heavy drinking days. Defined as five or more standard units of alcohol in a day for a man and four or more standard units of alcohol in a day for a woman. Alcohol use is measured via a combination of the digital app and the Timeline Follow-Back Questionnaire.
Measured: Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).
Secondary outcomes (19)
Changes in glutamat levels during craving
Changes in glutamatergic signalling in the NAcc measured via Magnetic Resonance Spectroscopy (MRS) during craving vs neutral cue exposure.
Measured: During the intervention visit 1a and 1 week later during the intervention visit 2.
Changes in Brain Derived Neurotrophic Factor
Treatment-induced changes in neuroplasticity assessed using the brain derived neurotrophic factor (BDNF) through blood analysis.
Measured: During the intervention visit 2 at baseline 30 minutes before and 2 hours after infusion start.
Individual variations in ketamine pharmacokinetics
Changes in ketamine plasma concentrations and its metabolites measured via blood samples taken.
Measured: During the intervention visit 2 at baseline, 45 minutes, 1 hour 30 minutes before, and 2 hours 30 minutes after infusion start.
Predictive value of baseline rs-fMRI for treatment response
Predictive value of rs-fMRI for treatment response assessed via the two primary outcomes
Measured: Between 1 and 2 weeks after baseline (screening visit) during the intervention visit 1a.
Changes in alcohol use in blood alcohol metabolites
Blood samples will be collected to analyse markers of alcohol use. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT) and Phosphatidyl Ethanol (PEth) will be analysed from blood samples.
Measured: At baseline (screening visit) and 4 weeks later (integration visit).
Severity of alcohol use disorder
Changes in severity of alcohol use disorder score assessed by the Obsessive Compulsive Drinking Scale, ranging from 0 to 56, where higher scores indicate more compulsive behaviors and obsessive thoughts to use alcohol.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Changes in alcohol abstinence ability
Changes in individuals confidence in their ability to abstain from alcohol in high risk situations assessed with the Alcohol Abstinence Self-Efficacy Scale, ranging from 0 to 160, where higher scores indicate higher self-confidence in the ability to avoid drinking.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Experience of alcohol craving
The Visual Analogue Scale for Alcohol Craving on a scale ranging from 0 to 100, where higher scores indicate higher subjective experience of craving.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Depressive symptoms
Changes in depressive symptoms measured with Beck Depression Inventory. The scale ranges from 0 to 63 where higher scores indicate more severe depressive symptoms.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Experience of pleasure across different domains
Changes in the experience of pleasure across different domains assessed by the Domains of Pleasure Scale, ranging from 0 to 210, where a higher score indicates a higher experience of pleasure.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Hedonic capacity
Changes in hedonic capacity measured by the Trait Hedonic Capacity Scale, ranging from 16 to 80, where a higher score indicates a higher hedonic capacity.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Perceived quality of life
Changes in the perceived quality of life assessed with the Quality of Life Scale, ranging from 0 to 400, whereas higher scores indicate higher perceived quality of life.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Posttraumatic stress symptoms
Changes in posttraumatic stress symptoms measured with Posttraumatic Stress Disorder Checklist for DSM-5. The scale ranges from 0 to 80, where higher scores indicate more severe posttraumatic stress symptoms.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Perceived stress
Changes in perceived stress assessed with a subscale of the Stress \& Coping Inventory, ranging from 21 to 147, where higher scores indicate higher perceived stress.
Measured: From baseline (screening visit) until 6 months later (follow-up survey II).
Subjective effects of ketamine infusion
Assess the acute subjective effects of the infusion with the Five-Dimension Altered State of Consciousness Questionnaire (5D-ASC), ranging from 0 to 100, where higher scores indicate the occurence of altered states of consciousness.
Measured: 2 hours after the ketamine infusion (intervention visit 2).
Effects of ketamine infusion on mystic experiences
Assess the acute subjective effects of the infusion with the Hood's Mysticism Scale, ranging from 20 to 100 where higher scores indicate the occurence of mystic experiences.
Measured: 2 hours after the ketamine infusion (intervention visit 2).
Neurofeedback Experience
The Neurofeedback Post Questionnaire (NF-PostQ) asks participants about their used strategies and experiences during neurofeedback training.
Measured: After neurofeedback training (intervention visit 1b) and up to two weeks later (intervention visit 2).
Daily alcohol use and craving
A Digital app (SEMA3) will document daily alcohol craving and alcohol use using an Ecological Momentary Assessment method.
Measured: From baseline (screening visit) up to 5 months later (one month prior to follow-up survey II).
Alcohol use in urine alcohol metabolites
Changes in alcohol metabolites via urine analyses as objective measure of alcohol use.
Measured: From baseline (screening visit) up to one month later (Integration visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse/DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. med. Marcus Herdener
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Dr. med. Marcus Herdener, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969937
- Sponsor's protocol ID
- 2024-02294
- Acronym
- Nektar
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our data will be published on the website of Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06969937
- Acronym / sponsor ID
- Nektar / 2024-02294
- Keywords
- Alcohol Use Disorder, Alcoholism, Alcohol Dependence, Ketamine, Glutamate, Placebo-controlled, Neurofeedback Training, Realtime fMRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Dr. med. Marcus HerdenerUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 accumbens (NAcc) are crucial for cue-induced drug-seeking behavior, at least in animal models of addiction (Kalivas, 2009). In line with this, three randomized controlled trials have been conducted exploring ketamine as a treatment for alcohol use disorder (AUD) or harmful drinking, each combining ketamine with either memory retrieval destabilization procedures or psychological therapy (Dakwar et al., 2020a; Das et al., 2019a; Grabski et al., 2022a). While ketamine consistently reduced alcohol use in these studies, the variability in treatment responses highlights the need for further investigation into the role of the glutamate system in AUD as well as optimal treatment approaches that maximize safety and efficacy for patients.
Given the significant need to advance both mechanistic and clinical understanding of AUD, this study aims to: (1) explore the role of glutamatergic neurotransmission in AUD; (2) determine whether ketamine can modulate potentially pathophysiological altered glutamate neurotransmission, and how such modulation may be influenced by ketamine metabolism ; and (3) optimize ketamine as a treatment for AUD by leveraging synergies between the additional biological mechanism of action of ketamine (i.e., induced neuroplasticity) and a targeted non-pharmacological neuromodulatory intervention, such as neurofeedback training (NFT), to maximize clinical outcomes.
To evaluate both the mechanistic and therapeutic effects of a single ketamine infusion and rt-fMRI NFT as well as their combined application on AUD, we will assess glutamatergic signalling in the NAcc, changes in neuroplasticity via BDNF, inter-individual differences in the metabolism of ketamine, and clinical symptoms in individuals with AUD.
Therefore, in this randomized, placebo-controlled, double blind, parallel group, single centre study we investigate the extend to which a single administration of ketamine and neurofeedback training, as well as the combination of the two interventions can restore neurobiological changes related to alcoholism and what effect this new treatment method has on the symptoms of AUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| rt-fMRI NFT / Ketamine | Experimental | Drug: Ketamine, Behavioral: Real-time fMRI Neurofeedback TrainingParticipants get real time neurofeedback based on an experimental regions' activity and receive 0.8 mg ketamine (i.v.) per kilogram bodyweight. |
| sham rt-fMRI NFT / Ketamine | Experimental | Drug: Ketamine, Behavioral: Sham Neurofeedback Training/ KetamineParticipants 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. |
| rt-fMRI NFT / Placebo | Experimental | Behavioral: Real-time fMRI Neurofeedback Training, Drug: PlaceboParticipants get real time neurofeedback based on an control regions' activity and receive a 0.9% NaCL infusion (placebo). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineA single dose of ketamine 0.8 mg ketamine (i.v.) per kilogram bodyweight | Drug | rt-fMRI NFT / Ketamine, sham rt-fMRI NFT / Ketamine |
| Real-time fMRI Neurofeedback TrainingParticipants 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. | Behavioural | rt-fMRI NFT / Ketamine, rt-fMRI NFT / Placebo |
| PlaceboSingle dose of placebo (0.9% NaCl infusion) | Drug | rt-fMRI NFT / Placebo |
| Sham Neurofeedback Training/ KetamineParticipants 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. | Behavioural | sham rt-fMRI NFT / Ketamine |
Primary outcome
Change in mean alcohol use per day
Time frame: Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).
Change in mean alcohol use per day. Alcohol use is measured via a combination of the digital app and the Timeline Follow-Back Questionnaire.
Change in heavy drinking days
Time frame: Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).
Change in heavy drinking days. Defined as five or more standard units of alcohol in a day for a man and four or more standard units of alcohol in a day for a woman. Alcohol use is measured via a combination of the digital app and the Timeline Follow-Back Questionnaire.
19 secondary outcomes
Changes in glutamat levels during craving
Time frame: During the intervention visit 1a and 1 week later during the intervention visit 2.
Changes in Brain Derived Neurotrophic Factor
Time frame: During the intervention visit 2 at baseline 30 minutes before and 2 hours after infusion start.
Individual variations in ketamine pharmacokinetics
Time frame: During the intervention visit 2 at baseline, 45 minutes, 1 hour 30 minutes before, and 2 hours 30 minutes after infusion start.
Predictive value of baseline rs-fMRI for treatment response
Time frame: Between 1 and 2 weeks after baseline (screening visit) during the intervention visit 1a.
Changes in alcohol use in blood alcohol metabolites
Time frame: At baseline (screening visit) and 4 weeks later (integration visit).
Severity of alcohol use disorder
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Changes in alcohol abstinence ability
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Experience of alcohol craving
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Depressive symptoms
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Experience of pleasure across different domains
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Hedonic capacity
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Perceived quality of life
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Posttraumatic stress symptoms
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Perceived stress
Time frame: From baseline (screening visit) until 6 months later (follow-up survey II).
Subjective effects of ketamine infusion
Time frame: 2 hours after the ketamine infusion (intervention visit 2).
Effects of ketamine infusion on mystic experiences
Time frame: 2 hours after the ketamine infusion (intervention visit 2).
Neurofeedback Experience
Time frame: After neurofeedback training (intervention visit 1b) and up to two weeks later (intervention visit 2).
Daily alcohol use and craving
Time frame: From baseline (screening visit) up to 5 months later (one month prior to follow-up survey II).
Alcohol use in urine alcohol metabolites
Time frame: From baseline (screening visit) up to one month later (Integration visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Yes. Our data will be published on the website of Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Real-time fMRI Neurofeedback Training in people with Alcohol Abuse/Dependence and Alcohol Use Disorder (AUD), run by Dr. med. Marcus Herdener at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Herdener, PD Dr. med. (+41583845810, marcus.herdener@bli.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean alcohol use per day (time frame: Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.