An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Ethanol; Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.