Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511836
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2007-08-02
Brief Title:
ALK21-018 Effects of Medisorb Naltrexone VIVITROL on Alcohol Craving in Treatment-seeking Alcohol-dependent Adults
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
The Effects of VIVITROL on Alcohol-Related Cue-Induced Craving and BOLD Blood Oxygen-level-dependent Functional Magnetic Resolution Imaging fMRI Signal Activation Patterns
Status:
COMPLETED
Status Verified Date:
2017-06
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 was a study of the effects of VIVITROL on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence The study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal increases in response to alcohol-related cues
In the double-blind portion subjects received a single administration of study drug VIVITROL 380 mg or placebo Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg
In the double-blind portion subjects received a single administration of study drug VIVITROL 380 mg or placebo Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg
Detailed Description:
The double-blind phase consisted of 6 visits over a 5- to 6-week period and included 2 telephone contacts and 2 functional magnetic resonance imaging fMRI scans
The optional open-label extension included 2 visits approximately 1 month apart Subjects who completed both phases participated in a total of 8 scheduled visits including 2 fMRI scans and 2 telephone contacts over a period of up to 14 weeks
At screening eligible consenting subjects were given an Actiwatch-Score device They were instructed to record their alcohol craving using this device throughout the double-blind phase The Actiwatch was programmed to beep every 3 hours 20 minutes thereby signaling the subjects to enter their craving or desire to use alcohol at that exact moment on a scale of 0 to 10 with 0 being no craving at all and 10 being extreme craving In addition subjects entered any drug andor alcohol use at the time of occurrence The Actiwatch was not utilized in the open-label portion of the study
The optional open-label extension included 2 visits approximately 1 month apart Subjects who completed both phases participated in a total of 8 scheduled visits including 2 fMRI scans and 2 telephone contacts over a period of up to 14 weeks
At screening eligible consenting subjects were given an Actiwatch-Score device They were instructed to record their alcohol craving using this device throughout the double-blind phase The Actiwatch was programmed to beep every 3 hours 20 minutes thereby signaling the subjects to enter their craving or desire to use alcohol at that exact moment on a scale of 0 to 10 with 0 being no craving at all and 10 being extreme craving In addition subjects entered any drug andor alcohol use at the time of occurrence The Actiwatch was not utilized in the open-label portion of the study
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