Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125054
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-10-26
Brief Title:
Ketamine and Neurofeedback-Training Effects on Neuroplasticity in Cocaine Addiction
Sponsor:
Dr med Marcus Herdener
Organization:
Psychiatric University Hospital Zurich
Study Overview
Official Title:
Boosting and Guiding Neuroplasticity by Combining Ketamine With Neurofeedback-assisted Learning - Towards an Individualized and Integrated Pharmaco-psychotherapy for Cocaine Addiction
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Co-Boost
Brief 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
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
Detailed Description:
Cocaine is the most frequently used stimulant worldwide and its consumption rate in Europe indicates a continuing upward trend Cocaine use is associated with great harms for affected individuals their families and the society Unfortunately until today no pharmacotherapy has been approved for the treatment of cocaine use disorder CUD due to lack of efficacy of tested compounds
The investigators therefore propose to use latest advancements in proton magnetic resonance spectroscopy 1H-MRS and real time functional magnetic resonance imaging neurofeedback training rt-fMRI NFT to develop a neurobiologically informed experimental approach for an individualized and integrated pharmaco-psychotherapy that has the potential to open new avenues for the treatment of CUD and in addition to be transferable to other neuropsychiatric conditions
To improve the efficacy of psychotherapeutic interventions in individuals with CUD the investigators recently developed an rt-fMRI NFT paradigm based on reward imagery to specifically modify maladaptive reward sensitivity by self-regulating the brains reward circuits
Furthermore using a 1H-MRS technique the investigators recently demonstrated that a disturbed glutamate homeostasis in the nucleus accumbens NAcc an important hub in the brains reward system characterizes cue-induced craving in CUD This indicates that urgently needed novel pharmacotherapies for addiction treatment should target the glutamatergic system
Thus to restore the glutamate homeostasis and to boost learning effect of the reward imagery training the investigators propose to combine reward imagery rt- fMRI NFT with the N-methyl-D-aspartate NMDA receptor antagonist ketamine which has direct effects both on glutamatergic signaling and neuroplasticity and has shown therapeutic potential to reduce cocaine craving and cocaine us
The investigators anticipate a restoration of the glutamate homeostasis in the NAcc b changes in maladaptive reward sensitivity resulting from rt-fMRI NFT and c synergistic effects of the pharmacological and the psychotherapeutic effect due to the ketamine-induced neuroplasticity that might open a window of opportunity for imagery-based learning The investigators hypothesize that these neurobiological adaptions induced by the described interventions underlie their therapeutic effects on cocaine craving and use
The effects of ketamine and reward imagery rt-fMRI NFT in individuals with CUD will be tested in a randomized placebo-controlled double blind parallel group study
The investigators therefore propose to use latest advancements in proton magnetic resonance spectroscopy 1H-MRS and real time functional magnetic resonance imaging neurofeedback training rt-fMRI NFT to develop a neurobiologically informed experimental approach for an individualized and integrated pharmaco-psychotherapy that has the potential to open new avenues for the treatment of CUD and in addition to be transferable to other neuropsychiatric conditions
To improve the efficacy of psychotherapeutic interventions in individuals with CUD the investigators recently developed an rt-fMRI NFT paradigm based on reward imagery to specifically modify maladaptive reward sensitivity by self-regulating the brains reward circuits
Furthermore using a 1H-MRS technique the investigators recently demonstrated that a disturbed glutamate homeostasis in the nucleus accumbens NAcc an important hub in the brains reward system characterizes cue-induced craving in CUD This indicates that urgently needed novel pharmacotherapies for addiction treatment should target the glutamatergic system
Thus to restore the glutamate homeostasis and to boost learning effect of the reward imagery training the investigators propose to combine reward imagery rt- fMRI NFT with the N-methyl-D-aspartate NMDA receptor antagonist ketamine which has direct effects both on glutamatergic signaling and neuroplasticity and has shown therapeutic potential to reduce cocaine craving and cocaine us
The investigators anticipate a restoration of the glutamate homeostasis in the NAcc b changes in maladaptive reward sensitivity resulting from rt-fMRI NFT and c synergistic effects of the pharmacological and the psychotherapeutic effect due to the ketamine-induced neuroplasticity that might open a window of opportunity for imagery-based learning The investigators hypothesize that these neurobiological adaptions induced by the described interventions underlie their therapeutic effects on cocaine craving and use
The effects of ketamine and reward imagery rt-fMRI NFT in individuals with CUD will be tested in a randomized placebo-controlled double blind parallel group study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None