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RECRUITING

NCT06125054

PHASE2

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

Sponsor: Dr. med. Marcus Herdener

View on ClinicalTrials.gov

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 cocaine use disorder. The main questions the investigators aim to answer are: * Can the investigators observe a positive, significant effect on percentage of cocaine use days of both interventions combined as well as stand alone interventions? * Is there a significant transfer effect of the neurofeedback training? * Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens? Participants will be given ketamine and a realtime fMRI neurofeedback training. Both interventions are placebo-controlled. The investigators will compare the four intervention groups to investigate the effects of the stand-alone effects of the intervention and the combination of it.

Official title: Boosting and Guiding Neuroplasticity by Combining Ketamine with Neurofeedback-assisted Learning - Towards an Individualized and Integrated Pharmaco-psychotherapy for Cocaine Addiction

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-02-05

Completion Date

2026-03

Last Updated

2024-12-20

Healthy Volunteers

Conditions

Cocaine Use Disorder Cocaine Dependence

Interventions

DRUG

Ketamine

single dose of ketamine (0.71mg/kg bodyweight i.v. over 40 minutes)

DRUG

Placebo

single dose of placebo (0.9% saline solution i.v. over 40 minutes)

BEHAVIORAL

real-time fMRI neurofeedback training

Real-time fMRI based neurofeedback over 20 minutes where participants are instructed to perform reward imagery. The feedback is based on an experimental region. The training is repeated three times.

BEHAVIORAL

sham real-time fMRI neurofeedback training

Sham real-time fMRI neurofeedback training over 20 minutes where participants are instructed to perform reward imagery. The feedback is based on a control region. The training is repeated three times.

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

Locations (1)

Psychiatric University Hospital Zurich, University of Zurich

Zurich, Canton of Zurich, Switzerland