Ketamine in Combination with Neurofeedback-based Learning: A New Pharmacopsychotherapeutic Approach to Treating Cocaine Dependence
Résumé de l'étude
Cocaine is the most widely consumed stimulant in the world, and its use is particularly prevalent in Switzerland. To date, there are no approved pharmacological treatment options for cocaine dependence (CD), a condition often associated with severe consequences, and psychotherapeutic therapies show only limited effectiveness. In individuals with CD, glutamate metabolism in the brain's reward system is altered. These changes are associated with craving, a core symptom of the condition. Therefore, glutamate metabolism is a promising target for new pharmacological treatment approaches. In our study, we will investigate to what extent ketamine can normalize the altered glutamate metabolism in CD and thereby reduce craving and cocaine use. Additionally, we have developed a neurofeedback training based on functional magnetic resonance imaging (fMRI-NFB). In this context, individuals with CD receive feedback almost in real-time about their brain activity in the so-called reward regions. These play a significant role in the condition: often, individuals with CD have reduced sensitivity to positive experiences not associated with drug use. Through mental imagery techniques and with the help of neurofeedback signals, patients can learn to regulate their brain's reward system in a way that strengthens this sensitivity again. The study aims to show whether these specific learning processes lead to a long-term change in consumption behavior. We also investigate the potentially synergistic therapeutic effects of the pharmacopsychotherapeutic combination treatment with fMRI-NFB and ketamine on consumption behavior. The insights gained could be helpful in further developing therapeutic options for other mental disorders.
(BASEC)
Intervention étudiée
- Single administration of ketamine, administered intravenously (0.71 mg/kg body weight)
- Real-time fMRI neurofeedback training
(BASEC)
Maladie en cours d'investigation
Cocaine dependence
(BASEC)
- Cocaine dependence - Age between 18 and 55 years - Normal language comprehension (German or Swiss German) (BASEC)
Critères d'exclusion
- Current or past history of a psychotic disorder - Current suicidality - Contraindication for magnetic resonance imaging (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Marcus Herdener
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Marcus Herdener
+41 58 384 58 11
marcus.herdener@clutterbli.uzh.chPsychiatric University Hospital Zurich, University of Zurich Adult Psychiatry and Psychotherapy Centre for Addictive Disorders Selnaustrasse 9 8001 Zürich Switzerland
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
06.12.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT06125054 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Boosting and guiding neuroplasticity by combining ketamine with neurofeedback-assisted learning – towards an individualized and integrated pharmaco-psychotherapy for cocaine addiction (BASEC)
Titre académique
Boosting and Guiding Neuroplasticity by Combining Ketamine with Neurofeedback-assisted Learning - Towards an Individualized and Integrated Pharmaco-psychotherapy for Cocaine Addiction (ICTRP)
Titre public
Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction (ICTRP)
Maladie en cours d'investigation
Cocaine Use Disorder;Cocaine Dependence (ICTRP)
Intervention étudiée
Drug: Ketamine;Drug: Placebo;Behavioral: real-time fMRI neurofeedback training;Behavioral: sham real-time fMRI neurofeedback training (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: 55 Years
Minimum age: 18 Years
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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Decrease in proportion of cocaine use days;Changes in fMRI signal of neurofeedback training;Changes in accumbal glutamate levels (ICTRP)
Changes in urine cocaine and cocaine metabolites;Cocaine craving;Severity of cocaine use disorder;Current motivation to change cocaine use behaviour;Hedonic capacity;Experience of pleasure across different domains;Emotion regulation skills;Depressive symptoms;Perceived stress;Self-esteem;Self-efficacy, optimism, and pessimism;Subjective effects of ketamine infusion;Effects of ketamine infusion on mystic experiences;Sustained changes in accumbal glutamate levels;Glutamate levels during craving paradigm;Changes in Brain Derived Neurotrophic Factor (ICTRP)
Date d'enregistrement
26.10.2023 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
University of Zurich;University of Vienna;University of Campania Luigi Vanvitelli (ICTRP)
Contacts supplémentaires
Marcus Herdener, PD Dr. med.;Marcus Herdener, PD Dr. med., marcus.herdener@bli.uzh.ch, +41583845810;+41583845810 (ICTRP)
ID secondaires
Co-Boost_PUK_2022-01859 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06125054 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible