Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03418623
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2018-01-08
Brief Title:
Effect of GET73 on MRS Measures of Central Glutamate and GABA in Individuals With Alcohol Use Disorder
Sponsor:
Laboratorio Farmaceutico Ct Srl
Organization:
Laboratorio Farmaceutico Ct Srl
Study Overview
Official Title:
Effect of GET73 on Magnetic Resonance Spectroscopy Measures of Central Glutamate and GABA and Alcohol Cue-elicited Brain Activation in Recently Abstinent Non-treatment Seeking Individuals With Alcohol Use Disorder
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
This study is aimed at examining whether GET73 modulates the indices of central glutamate and γ-aminobutyric acid GABA levels in recently abstinent subjects that meet Alcohol Use Disorder AUD criteria as measured by proton nuclear magnetic resonance spectroscopy ¹H-MRS in order to provide a human translation of the findings demonstrated in different preclinical models both in vitro and in vivo In addition the study will examine the effects of GET73 on alcohol cue induced brain activation by using a well-established blood-oxygen-level-dependent BOLD functional magnetic resonance fMRI paradigm in the same individuals In summary the study should provide important information on i the potential mechanism of action of GET73 ii on the brain mechanisms that would support its potential use for reduction in craving and drinking in AUD patients and iii expand data on its safe use as a medication in heavy drinking individuals
Detailed Description:
This study is aimed at examining whether GET73 modulates the indices of central glutamate and γ-aminobutyric acid GABA levels in recently abstinent subjects that meet Alcohol Use Disorder AUD criteria as measured by proton nuclear magnetic resonance spectroscopy ¹H-MRS in order to provide a human translation of the findings demonstrated in different preclinical models both in vitro and in vivo In addition the study will examine the effects of GET73 on alcohol cue induced brain activation by using a well-established blood-oxygen-level-dependent BOLD functional magnetic resonance fMRI paradigm in the same individuals In summary the study should provide important information on i the potential mechanism of action of GET73 ii on the brain mechanisms that would support its potential use for reduction in craving and drinking in AUD patients and iii expand data on its safe use as a medication in heavy drinking individuals
The enrolment period will last approximately 18 to 21 months For each subject the study will last 25 to 45 days
The primary objective of the study is to evaluate whether GET73 modulates central glutamate levels in recently abstinent individuals with AUD using proton nuclear magnetic resonance spectroscopy ¹H-MRS
The secondary objectives of the study are
1 To evaluate whether GET73 modulates central GABA levels in recently abstinent individuals with AUD using proton nuclear magnetic resonance spectroscopy ¹H-MRS
2 To evaluate whether GET73 affects alcohol cue induced brain activity in reward areas of brain
3 To explore whether the effects of GET73 on glutamate and GABA levels are related to its effects on alcohol cue induced brain activity
Safety Objective To evaluate the safety profile of GET73 in individuals with AUD comparing Adverse Events AEs occurrence during GET73 treatment period vs placebo treatment period
This is a within-subject cross-over randomized double-blind placebo-controlled study
Being a double blinded study GET73 and placebo will be packaged identically Both the Investigator and the study participant will be unaware of the treatment administered
The investigational product will be supplied to the Center packaged in patient kits Each patient kit will be made of 2 bottles bottle A and bottle B each containing 20 capsules of either GET73 or placebo
Being a cross-over design all participants will receive both placebo and active treatment The sequential order in which they will be administered to each participant will be defined by the randomization list The participant will always receive bottle A in the phase A of the study and bottle B in phase B but the content of the two bottles varies according to the randomization list Research personnel will be blind to the content of the bottles ie what study medication the subject is taking
The enrolment period will last approximately 18 to 21 months For each subject the study will last 25 to 45 days
The primary objective of the study is to evaluate whether GET73 modulates central glutamate levels in recently abstinent individuals with AUD using proton nuclear magnetic resonance spectroscopy ¹H-MRS
The secondary objectives of the study are
1 To evaluate whether GET73 modulates central GABA levels in recently abstinent individuals with AUD using proton nuclear magnetic resonance spectroscopy ¹H-MRS
2 To evaluate whether GET73 affects alcohol cue induced brain activity in reward areas of brain
3 To explore whether the effects of GET73 on glutamate and GABA levels are related to its effects on alcohol cue induced brain activity
Safety Objective To evaluate the safety profile of GET73 in individuals with AUD comparing Adverse Events AEs occurrence during GET73 treatment period vs placebo treatment period
This is a within-subject cross-over randomized double-blind placebo-controlled study
Being a double blinded study GET73 and placebo will be packaged identically Both the Investigator and the study participant will be unaware of the treatment administered
The investigational product will be supplied to the Center packaged in patient kits Each patient kit will be made of 2 bottles bottle A and bottle B each containing 20 capsules of either GET73 or placebo
Being a cross-over design all participants will receive both placebo and active treatment The sequential order in which they will be administered to each participant will be defined by the randomization list The participant will always receive bottle A in the phase A of the study and bottle B in phase B but the content of the two bottles varies according to the randomization list Research personnel will be blind to the content of the bottles ie what study medication the subject is taking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None