Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02626494
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2015-05-20
Brief Title:
Neurobiological Adaptations and Pharmacological Interventions in Cocaine Addiction
Sponsor:
Psychiatric University Hospital Zurich
Organization:
Psychiatric University Hospital Zurich
Study Overview
Official Title:
Neurobiological Adaptations and Pharmacological Interventions in Cocaine Addiction The Role of Glutamate
Status:
COMPLETED
Status Verified Date:
2017-04
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:
CoGlu
Brief Summary:
This study aims at testing for the impact of glutamatergic changes on drug craving in cocaine addiction and to evaluate the effects of n-acetylcysteine n-AC on both glutamate homeostasis and craving using a randomized double-blind placebo controlled cross-over design
Detailed Description:
Cocaine addiction is a devastating disorder with potentially harmful psychological physical and social consequences Despite its clinical importance there is currently no approved pharmacological treatment available for cocaine addiction However preclinical research has recently identified potentially promising targets for pharmacotherapeutic approaches mainly based on advances in the understanding of neuroplastic alterations associated with repeated cocaine administration in animals
Preclinical animal models revealed that chronic administration of cocaine leads to decreased basal levels of glutamate within the nucleus accumbens a key region of the neural reward circuitry in turn the reinstatement of drug seeking results in enhanced glutamatergic transmission However little is known about similar changes in humans and about their functional role for addictive behavior mainly due to methodological restrictions The investigators thus aim to examine the changes associated with chronic cocaine use on glutamate homeostasis in humans using a newly developed proton magnetic resonance spectroscopy 1H-MRS protocol This method allows for the quantification of brain metabolites such as glutamate in specific regions of the human brain even within small subcortical volumes of interest such as the nucleus accumbens that have been hitherto difficult to assess
Interestingly the administration of n-AC restored the glutamate homeostasis in rats and reduced their drug reinstatement behavior Therefore the present study aims at investigating if a pharmacological challenge of n-AC influences glutamate homeostasis in humans and whether these possible modulations are linked to cocaine craving
Power analyses to identify the sample size of this study were done with a focus on 1H-MRS the most critical procedure in this context within our project Assuming a mean conservative effect size of d080 an α-error probability of 5 and a conservative power estimation of 80 and considering a drop-out rate of about 30 investigators plan to measure 30 cocaine dependent patients and 30 healthy controls
Imaging data of low quality eg due to movement artifacts will be excluded If imaging data has to be excluded or if participants do not finish the experiment the investigators will additionally recruit more participants in order to assess the planned sample size
Throughout the duration of the entire study the conductance of pre-defined key processes will constantly be monitored by an independent monitor in specified visit intervals to ensure that the study is conducted in accordance with the approved protocol good clinical practice and the applicable regulatory requirement in order to protect the rights and well-being of study participants and integrity of data
Preclinical animal models revealed that chronic administration of cocaine leads to decreased basal levels of glutamate within the nucleus accumbens a key region of the neural reward circuitry in turn the reinstatement of drug seeking results in enhanced glutamatergic transmission However little is known about similar changes in humans and about their functional role for addictive behavior mainly due to methodological restrictions The investigators thus aim to examine the changes associated with chronic cocaine use on glutamate homeostasis in humans using a newly developed proton magnetic resonance spectroscopy 1H-MRS protocol This method allows for the quantification of brain metabolites such as glutamate in specific regions of the human brain even within small subcortical volumes of interest such as the nucleus accumbens that have been hitherto difficult to assess
Interestingly the administration of n-AC restored the glutamate homeostasis in rats and reduced their drug reinstatement behavior Therefore the present study aims at investigating if a pharmacological challenge of n-AC influences glutamate homeostasis in humans and whether these possible modulations are linked to cocaine craving
Power analyses to identify the sample size of this study were done with a focus on 1H-MRS the most critical procedure in this context within our project Assuming a mean conservative effect size of d080 an α-error probability of 5 and a conservative power estimation of 80 and considering a drop-out rate of about 30 investigators plan to measure 30 cocaine dependent patients and 30 healthy controls
Imaging data of low quality eg due to movement artifacts will be excluded If imaging data has to be excluded or if participants do not finish the experiment the investigators will additionally recruit more participants in order to assess the planned sample size
Throughout the duration of the entire study the conductance of pre-defined key processes will constantly be monitored by an independent monitor in specified visit intervals to ensure that the study is conducted in accordance with the approved protocol good clinical practice and the applicable regulatory requirement in order to protect the rights and well-being of study participants and integrity of data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None