Status:
COMPLETED
Aripiprazole and Topiramate on Free-Choice Alcohol Use
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsors:
Brown University
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer l...
Detailed Description
Due to the modest effect of current pharmacotherapies, more effective treatments must be developed to optimally treat alcohol dependent patients. Treatments combining pharmacotherapies with different ...
Eligibility Criteria
Inclusion
- must be non-treatment seeking for alcohol dependence
- a current DSM-IV-TR diagnosis of alcohol dependence supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders Patient Edition (SCID-I/P a minimum of ≥ 35drinks a week for men or ≥ 28 or more drinks a week for women
- must be suitable for outpatient treatment
- able to read English at an eighth grade level, understand their rights as provided by the informed consent, and be willing to sign an informed consent to participate in the study
- be between 21 and 65 years on age (inclusive)
- provide evidence of stable residence in the two months prior to enrollment and no plans to move for the next four months
- provide a verifiable contact person prior to randomization
- be in generally good health as determined by the physical exam, medical history, ECG and laboratory tests
- have a Body Mass Index \>18kg/m2 and \< 33 kg/m2
- if female, must be postmenopausal practicing an effective method of birth control, have negative pregnancy tests at randomization and before the ASAE;
- be willing to be adherent to medication dosing.
Exclusion
- clinically significant medical abnormalities (i.e. ECG, hematological assessment, bilirubin \> 150% of the upper limit of normal or ALT or AST elevations \>300% the upper limit of normal, biochemistry including urinalysis, electrolytes,). (Persons with medical conditions that are adequately controlled by their primary care physician will not be excluded.)
- have significant alcohol withdrawal symptoms (clinical institute withdrawal assessment for alcohol revised (CIWA-Ar) \>10
- a history of suicide; history of renal impairment or nephrolithiasis; creatinine clearance of \<60 dl/minute
- pregnant or lactating or not using an adequate form of birth control
- taking other medications that may have an effect on alcohol consumption or are carbonic anhydrase inhibitors
- clinically significant diseases of the gastrointestinal system or active liver disease; subjects compelled to receive treatment to avoid imprisonment or loss of employment
- previously with a history of adverse reaction or hypersensitivity to either Topiramate or aripiprazole
- have a diagnosis of with schizophrenia or bipolar disorder and/or taking antipsychotics and other drugs that inhibit CYP3A4 or CYP2D6 isoenzymes
- history of seizures (e.g. epilepsy)
- patients currently diagnosed with a substance dependence diagnosis other than alcohol or tobacco
- patients who have participated in any clinical trial with an investigational agent within the past 30 days
- individuals with a reasonable expectation of being institutionalized during the course of the trial or pending legal charges
- pregnant or nursing women.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00884884
Start Date
September 1 2007
End Date
October 1 2015
Last Update
October 7 2015
Active Locations (1)
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1
Brown University Center for Addiction Studies
Providence, Rhode Island, United States, 02903