Status:
COMPLETED
An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence.
Detailed Description
The impact of alcoholism can be reduced through effective treatments, which may include medical, psychological, and social interventions. The main goals of alcohol-dependence treatment are to assist p...
Eligibility Criteria
Inclusion
- Have a current diagnosis of alcohol dependence
- drink an average of 28 or more standard drinking units/week for women or 35 or more standard drinking units/week for men
- have a desire to stop drinking completely or to reduce alcohol consumption with the possible long-term goal of abstinence
- have a body mass index of 18 or more
- sexually active women capable of having children must be using an acceptable method of birth control
- must be in generally good health.
Exclusion
- No current or recent (within 6 months) diagnosis of other substance abuse or dependence
- no inpatient or outpatient counseling for alcohol dependence other than Alcoholics Anonymous within 4 weeks
- not more than 4 past failed inpatient treatments attempts for alcohol dependence
- no other psychiatric disorder that requires treatment with medication or therapy
- no current probation or parole requirement or legally mandated requirement to participate in an alcohol treatment program.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT00210925
Start Date
March 1 2004
End Date
August 1 2006
Last Update
June 8 2011
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