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New treatment option for Alcohol Abuse/Dependence
Official title Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06969937
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alcohol abuse/dependence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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 \ 35
- Allergy, hypersensitivity, or other adverse reaction to previous use of ketamine
- Contradictions to magnetic resonance imaging
- Concurrent participation in other clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.