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Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572117
First Posted: December 12, 2007
Last Update Posted: January 9, 2017
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.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Michael Ostacher, Stanford University
Results First Submitted: August 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Alcoholism
Alcohol Dependence
Intervention: Drug: Topiramate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Topiramate

Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.

Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.

Placebo (Inert Pill) Arm

Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.

Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.


Participant Flow:   Overall Study
    Topiramate   Placebo (Inert Pill) Arm
STARTED   5   7 
COMPLETED   3   5 
NOT COMPLETED   2   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Topiramate

Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.

Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.

Placebo (Inert Pill) Arm

Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.

Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.

Total Total of all reporting groups

Baseline Measures
   Topiramate   Placebo (Inert Pill) Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   7   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.4  (10.8)   46.6  (8.3)   43.6  (9.7) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  40.0%      5  71.4%      7  58.3% 
Male      3  60.0%      2  28.6%      5  41.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Amount of Alcohol Consumed   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Effect of Treatment on Mood Symptoms   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael J. Ostacher, MD, MPH, MMSc
Organization: Stanford University School of Medicine
phone: 650-493-5000
e-mail: ostacher@stanford.edu



Responsible Party: Michael Ostacher, Stanford University
ClinicalTrials.gov Identifier: NCT00572117     History of Changes
Other Study ID Numbers: TIL-NIAAA-016340-01
K23AA016340 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2007
First Posted: December 12, 2007
Results First Submitted: August 17, 2016
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017