Ketamine in Combination with Neurofeedback-based Learning: A New Pharmacopsychotherapeutic Approach to Treating Cocaine Dependence
Zusammenfassung der Studie
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)
Untersuchte Intervention
- Single administration of ketamine, administered intravenously (0.71 mg/kg body weight)
- Real-time fMRI neurofeedback training
(BASEC)
Untersuchte Krankheit(en)
Cocaine dependence
(BASEC)
- Cocaine dependence - Age between 18 and 55 years - Normal language comprehension (German or Swiss German) (BASEC)
Ausschlusskriterien
- Current or past history of a psychotic disorder - Current suicidality - Contraindication for magnetic resonance imaging (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Marcus Herdener
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
06.12.2022
(BASEC)
ICTRP Studien-ID
NCT06125054 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Boosting and guiding neuroplasticity by combining ketamine with neurofeedback-assisted learning – towards an individualized and integrated pharmaco-psychotherapy for cocaine addiction (BASEC)
Wissenschaftlicher Titel
Boosting and Guiding Neuroplasticity by Combining Ketamine with Neurofeedback-assisted Learning - Towards an Individualized and Integrated Pharmaco-psychotherapy for Cocaine Addiction (ICTRP)
Öffentlicher Titel
Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction (ICTRP)
Untersuchte Krankheit(en)
Cocaine Use Disorder;Cocaine Dependence (ICTRP)
Untersuchte Intervention
Drug: Ketamine;Drug: Placebo;Behavioral: real-time fMRI neurofeedback training;Behavioral: sham real-time fMRI neurofeedback training (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
26.10.2023 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Zurich;University of Vienna;University of Campania Luigi Vanvitelli (ICTRP)
Weitere Kontakte
Marcus Herdener, PD Dr. med.;Marcus Herdener, PD Dr. med., marcus.herdener@bli.uzh.ch, +41583845810;+41583845810 (ICTRP)
Sekundäre IDs
Co-Boost_PUK_2022-01859 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06125054 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar