Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction

Launched by DR. MED. MARCUS HERDENER · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a combination of ketamine, a medication often used for pain relief and depression, and special brain training using real-time brain imaging (called neurofeedback) can help people struggling with cocaine addiction. The researchers want to find out if this combination can reduce the days people use cocaine and if the brain training has lasting benefits. They will compare different groups of participants to see how each treatment works on its own and when combined.

To join the study, participants need to be between 18 and 55 years old and diagnosed with cocaine use disorder. They must be able to understand the study procedures in German or Swiss-German and agree to follow the study rules. Participants will receive either the ketamine, the neurofeedback training, both, or a placebo (a treatment without active ingredients) to compare the effects. It’s important for potential participants to know that there are certain health conditions and medications that could exclude them from the study to ensure their safety during the trial.

Gender

ALL

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