Status:
COMPLETED
Topiramate Treatment of Problem Drinkers
Lead Sponsor:
UConn Health
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Center for Research Resources (NCRR)
Conditions:
Alcohol Drinking
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of up to 200mg/day...
Detailed Description
It is estimated that 30% of the general population are problem drinkers (NIAAA 2007). Despite its high prevalence, problem drinkers are understudied, particularly with respect to medications that may ...
Eligibility Criteria
Inclusion
- age 18 to 65 years, inclusive;
- have an average weekly ethanol consumption of \>=24 standard drinks for men, or \>=18 standard drinks for women;
- be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment;
- be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study;
- if a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who are less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment;
- if applicable, individuals being treated with a single antidepressant that has been stable in dosage for a minimum of four weeks; and
- be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels).
Exclusion
- a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of \>110% or transaminase elevations \>300% normal (We will not exclude patients with hypertension, diabetes mellitus, asthma or other common medical conditions, as long as these are adequately controlled and the patient has an ongoing relationship with a primary-care practitioner);
- a history of nephrolithiasis;
- a history of glaucoma;
- a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, borderline or antisocial personality disorder, organic mood or mental disorders, eating disorder, or substantial suicide or violence risk) on the basis of history or psychiatric examination;
- a current Diagnostic \& Statistical Manual of Mental Disorders 4th ed (DSM-IV) diagnosis of drug dependence (other than nicotine dependence);
- a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) diagnosis of alcohol dependence that is clinically moderate or severe;
- a history of hypersensitivity to topiramate;
- currently taking any tricyclic antidepressant (e.g., Adapin (doxepin), Anafranil (clomipramine), Elavil (amitryptyline), Pamelor (nortryptyline), Tofranil (imipramine), Sinequan (doxepin); or
- are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00626925
Start Date
February 1 2008
End Date
November 1 2013
Last Update
March 8 2018
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104