Alcohol Dependence Clinical Trial
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
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.
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 and/or alcohol use at the time of occurrence. The Actiwatch was
not utilized in the open-label portion of the study.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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