An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence
Intervention: Placebo (Drug); Naltrexone (Drug); Naltrexone + Aripiprazole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Medical University of South Carolina Official(s) and/or principal investigator(s): Raymond F Anton, M.D., Principal Investigator, Affiliation: Medical University of South Carolina
Summary
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.
Clinical Details
Official title: An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: drinks per drinking day
Secondary outcome: Pill counts and urinary riboflavin levels during treatmentSubject-reported adverse events on the SAFTEE interview Percent heavy drinking days over the 16-week study
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 18 70
2. Subjects will meet criteria for primary alcohol dependence operationalized as
follows:
A. Meets the DSM IV criteria for alcohol dependence including loss of control over
drinking (criterion 3) B. Has not had more than one previous inpatient medical
detoxification
3. Consumes, on average, at least 10 standard drinks per drinking day for men and 8
drinks per day for women in the 90 days pre-screening (to select an appropriately
heavy drinking population)
4. Able to maintain sobriety for four days (with or without the aid of alcohol
detoxification medications) as determined by self report, collateral report, and
breathalyzer measurements
5. Able to read and understand questionnaires and informed consent
6. Lives within approximately 50 miles of the study site -
Exclusion Criteria:
1. Currently meets DSM IV criteria for any other psychoactive substance dependency
disorder except nicotine dependence
2. Ever abused opiates
3. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30
days as evidenced by subject report, collateral report, or urine drug screen
4. Meets DSM IV criteria for current axis I disorders of major depression, panic
disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar
affective disorder, schizophrenia, or any other psychotic disorder or organic mental
disorder
5. Meets DSM IV current criteria for dissociative disorder or eating disorders
6. Has current suicidal ideation or homicidal ideation
7. Need for maintenance or acute treatment with any psychoactive medication including
anti-seizure medications
8. Current use of disulfiram
9. Clinically significant medical problems such as cardiovascular, renal, GI, or
endocrine problem that would impair participation or limit medication ingestion
10. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at
least 3. 0 times normal at screening and/or after 5 days abstinence
11. Sexually active female of child-bearing potential who is pregnant (by urine HCG),
nursing, or who is not using a reliable form of birth control
12. Has current charges pending for a violent crime (not including DUI-related offenses)
13. Does not have a stable living situation and a reliable source of collateral reporting
14. Has taken an opiate antagonist drug in the last month
15. Has taken aripiprazole in the last month or has experienced adverse effects from it
at any time in the past
Locations and Contacts
Medical University of South Carolina, Center for Drug and Alcohol Programs, Charleston, South Carolina 29425, United States
Additional Information
Starting date: April 2008
Last updated: August 4, 2011
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