Effects of ketamine and neurofeedback on cocaine addiction
Boosting and Guiding Neuroplasticity by Combining Ketamine with Neurofeedback-assisted Learning - Towards an Individualized and Integrated Pharmaco-psychotherapy for Cocaine Addiction
This study is testing whether combining ketamine with brain training can help people struggling with cocaine addiction reduce their use and improve their brain function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Psychiatric University Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT06125054 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combined effects of ketamine and real-time functional magnetic resonance imaging (fMRI) neurofeedback training on individuals with cocaine use disorder. Participants will be assigned to one of four groups receiving either the combination of interventions or placebo treatments, allowing researchers to assess the efficacy of each approach. The study aims to measure changes in cocaine use days, the transfer effects of neurofeedback training, and alterations in glutamate levels in the nucleus accumbens. This innovative approach seeks to develop a new treatment paradigm for cocaine addiction by targeting the brain's reward system.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 55 with a DSM-5 diagnosis of cocaine use disorder.
Not a fit: Patients with current or lifetime psychotic disorders or severe substance use disorders other than cocaine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a novel treatment for cocaine addiction that enhances neuroplasticity and reduces cocaine use.
How similar studies have performed: While the combination of ketamine and neurofeedback is a novel approach, previous studies have shown promise in using ketamine for other forms of addiction treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zurich, Canton of Zurich
- Psychiatric University Hospital Zurich, University of Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Marcus Herdener, PD Dr. med.
- Email: marcus.herdener@bli.uzh.ch
- Phone: +41583845810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.