NCT06125054 Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction
| NCT ID | NCT06125054 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dr. med. Marcus Herdener |
| Condition | Cocaine Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-02-05 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 medication) * Any unstable psychoactive medication (no changes in compounds within last 4 weeks before start of study) * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06125054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Cocaine Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06125054 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06125054 currently recruiting?
Yes, NCT06125054 is actively recruiting participants. Contact the research team at marcus.herdener@bli.uzh.ch for enrollment information.
Where is the NCT06125054 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT06125054 clinical trial?
NCT06125054 is sponsored by Dr. med. Marcus Herdener. The trial plans to enroll 120 participants.