The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
placebo
Naltrexone (25mg or 50 mg per titration schedule)
Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
Medical University of South Carolina, Center for Drug and Alcohol Programs
Charleston, South Carolina, United States
Drinks Per Drinking Day
Standard drinks per drinking day
Time frame: 16-week treatment period
Percent Heavy Drinking Days
percent of total 112 day trial in which heavy drinking occurred (\>=4 for females, \>=5 male)
Time frame: 16 weeks
Pill Counts During Treatment
Compliance with medication as determined by pill counts
Time frame: 16-week
Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance
Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime
Time frame: 16 weeks treatment trial
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