Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction (NCT06125054) | Clinical Trial Compass
RecruitingPhase 2
Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction
Switzerland120 participantsStarted 2024-02-05
Plain-language 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 in individuals with cocaine use disorder. The main questions the investigators aim to answer are:
* Can the investigators observe a positive, significant effect on percentage of cocaine use days of both interventions combined as well as stand alone interventions?
* Is there a significant transfer effect of the neurofeedback training?
* Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens?
Participants will be given ketamine and a realtime fMRI neurofeedback training. Both interventions are placebo-controlled. The investigators will compare the four intervention groups to investigate the effects of the stand-alone effects of the intervention and the combination of it.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed Consent as documented by signature
* Male and female cocaine users 18 to 55 years of age
* diagnostic and statisical manual (DSM)-5 diagnosis of CUD
* Willingness to comply with the study protocol as explained by investigator
* Normal level of language comprehension (German or Swiss-German)
Exclusion Criteria:
* 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
* Current severe alcohol use disorder
* Current severe cannabis use disorder
* Current moderate or severe stimulant use disorder (other than cocaine)
* Current moderate or severe benzodiazepine use disorder
* Current opioid use disorder
* First-degree relatives with psychotic disorders
* Beck Depression Inventory Score greater than 25
* 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)
* Increased intracranial pressure
* Medication directly affecting glutamate signaling (e. g. anticonvulsant medicat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decrease in proportion of cocaine use days
Timeframe: Between 5 and 7 weeks after baseline (the first intervention visit)
2
Changes in fMRI signal of neurofeedback training
Timeframe: Between 1 and 2 weeks after baseline (the first neurofeedback training)