Status:
RECRUITING
Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction
Lead Sponsor:
Dr. med. Marcus Herdener
Collaborating Sponsors:
University of Zurich
University of Vienna
Conditions:
Cocaine Use Disorder
Cocaine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 cocain...
Detailed Description
Cocaine is the most frequently used stimulant worldwide, and its consumption rate in Europe indicates a continuing upward trend. Cocaine use is associated with great harms for affected individuals, th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06125054
Start Date
February 5 2024
End Date
March 1 2026
Last Update
December 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Psychiatric University Hospital Zurich, University of Zurich
Zurich, Canton of Zurich, Switzerland, 8032