We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00210925
First Posted: September 21, 2005
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence.

Condition Intervention Phase
Alcoholism Drug: topiramate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The change in percentage of heavy drinking days (5 or more standard drinking units per day for men and 4 or more standard drinking units per day for women) from baseline at 12 weeks or final visit.

Secondary Outcome Measures:
  • The change in each of the following: drinks/drinking day, drinks/day, percent days abstinent, Clinical Institute Withdrawal Assessment for Alcohol-revised, compared to baseline at 12 weeks or final visit.

Enrollment: 371
Study Start Date: March 2004
Study Completion Date: August 2006
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 patients in avoiding alcohol, developing better strategies for managing stress, and improving self-esteem and quality of life. Studies have demonstrated that treatments for alcohol use disorders can be effective, but their effectiveness is often limited. Although the optimal goal of treatment should be total abstinence, even patients who are unable to achieve this goal may still benefit from treatments leading to a reduction in drinking. Medications are commonly used in other addictive disorders, such as nicotine and opioid dependence, suggesting that this intervention could be useful in the treatment of alcohol dependence. This is a randomized, double-blind, flexible dose study to determine if topiramate, a prescription medication approved by the Food & Drug Administration for the treatment of epilepsy and the prevention of migraine, administered at a dose of 300mg per day or the subject's maximum tolerated dose, is safe and effective compared with placebo in patients with alcohol dependence. The study hypothesis is that topiramate will be more effective than placebo in reducing the percentage of heavy drinking days (5 or more standard drinks per day for men and 4 or more standard drinks per day for women) in patients with alcohol dependence. The patients will receive topiramate tablets (25mg and/or 100mg) or matching placebo. Study medication is taken in increasing doses starting at 25 mg/day up to 300 mg per day (or maximum tolerated dose) during the first 6 weeks and the achieved dose is maintained for an additional 8 weeks.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210925


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00210925     History of Changes
Other Study ID Numbers: CR004681
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 8, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
alcoholism
alcohol dependence
medication treatment.

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Topiramate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents