NCT00210925

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

June 6, 2011

Conditions

Alcoholism

Keywords

alcoholismalcohol dependencemedication treatment.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

topiramateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Johnson BA, Rosenthal N, Capece JA, Wiegand F, Mao L, Beyers K, McKay A, Ait-Daoud N, Anton RF, Ciraulo DA, Kranzler HR, Mann K, O'Malley SS, Swift RM; Topiramate for Alcoholism Advisory Board; Topiramate for Alcoholism Study Group. Topiramate for treating alcohol dependence: a randomized controlled trial. JAMA. 2007 Oct 10;298(14):1641-51. doi: 10.1001/jama.298.14.1641.

    PMID: 17925516RESULT

  • Falk DE, O'Malley SS, Witkiewitz K, Anton RF, Litten RZ, Slater M, Kranzler HR, Mann KF, Hasin DS, Johnson B, Meulien D, Ryan M, Fertig J; Alcohol Clinical Trials Initiative (ACTIVE) Workgroup. Evaluation of Drinking Risk Levels as Outcomes in Alcohol Pharmacotherapy Trials: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Psychiatry. 2019 Apr 1;76(4):374-381. doi: 10.1001/jamapsychiatry.2018.3079.

    PMID: 30865232DERIVED

  • Johnson BA, Rosenthal N, Capece JA, Wiegand F, Mao L, Beyers K, McKay A, Ait-Daoud N, Addolorato G, Anton RF, Ciraulo DA, Kranzler HR, Mann K, O'Malley SS, Swift RM; Topiramate for Alcoholism Advisory Board; Topiramate for Alcoholism Study Group. Improvement of physical health and quality of life of alcohol-dependent individuals with topiramate treatment: US multisite randomized controlled trial. Arch Intern Med. 2008 Jun 9;168(11):1188-99. doi: 10.1001/archinte.168.11.1188.

    PMID: 18541827DERIVED

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2004

Study Completion

August 1, 2006

Last Updated

June 8, 2011

Record last verified: 2010-04