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Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder
This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), November 2008
Sponsors and Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00572117
  Purpose

The purpose of this study is determine whether the use of topiramate is effective in the treatment of alcohol dependence (i.e. decreases drinking) in patients with bipolar disorder.


Condition Intervention Phase
Bipolar Disorder
Manic Disorder
Manic-Depressive
Alcoholism
Alcohol Abuse
Drug: Topiramate
Other: Placebo
Phase IV

MedlinePlus related topics: Alcoholism Bipolar Disorder
Drug Information available for: Topiramate Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Amount of alcohol consumed [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability of topiramate. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Effect of decreased drinking on mood symptoms [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Topiramate -- Subjects will continue Weeks 5-12 of the study.
Drug: Topiramate
Medication will be titrated slowly over 5 weeks from 25 mg qD to 150 mg BID in an effort to minimize side effects and the possible unblinding of participants and raters to treatment. Subjects will continue on 150 mg BID for Weeks 5-12 of the study.
2: Placebo Comparator
placebo
Other: Placebo
placebo

Detailed Description:

Alcohol and substance use disorders are more common in bipolar disorder bipolar disorder than in any other DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) Axis I disorder, estimated to occur in up to 60% of patients with bipolar disorder. Alcohol use is associated with poor outcome in bipolar disorder, and yet these co-occurring conditions are understudied. To date, there is only one published placebo-controlled trial of an agent for the treatment of alcohol dependence alcohol dependence in bipolar disorder. The purpose of the proposed study is to evaluate the efficacy of a topiramate as a treatment for alcohol dependence in patients with bipolar disorder. This is a 12-week, randomized, placebo-controlled study of the efficacy of topiramate adjunctive to standard treatment for bipolar disorder in patients with alcohol dependence and bipolar disorder. Additional aims of the study are to document the safety and tolerability of topiramate in this population, and to evaluate to effect of decreased drinking on mood symptoms. The study involves the enrollment of a total of 80 patients with co-occurring alcohol dependence and bipolar disorder over the course of 40 months at the Massachusetts General Hospital (MGH) Bipolar Clinic and Research Program (BCRP) (www.manicdepressive.org). With a conservative estimate of a 30% dropout rate, approximately 56 of the 80 patients with these two comorbid conditions will complete 12 weeks treatment with either topiramate or placebo.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18+
  2. Written informed consent.
  3. Meet DSM-IV criteria (by SCID) for alcohol dependence.
  4. Meet DSM-IV criteria (by SCID) for bipolar disorder I or II disorder.
  5. ≥ 8 heavy drinking days (defined as ≥ 5 standard drinks per day for men, ≥ 4 standard drinks per day for women) in the prior 4 weeks.
  6. During the baseline visit, patients must be on a stable dose of accepted maintenance treatment for bipolar disorder for the past 4 weeks. If the subject is on more than one agent, at least one agent must be adequately dosed.
  7. Antidepressant treatment is permitted if the dose has been stable for the past 4 weeks.

Exclusion Criteria:

  1. Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy). Because of the risk of the lowering of oral contraceptive blood levels with topiramate, women whose sole means of contraception is oral contraceptives or hormonal implants will be asked to use an additional barrier method of birth control during treatment with the study drug.
  2. Women who are lactating.
  3. Age under 18.
  4. Patients who do not have ≥ 8 heavy drinking days in the 4 weeks prior to the baseline visit.
  5. Important alcohol withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol-Revised, CIWA-Ar, score > 15)
  6. Urine toxicological screen positive for amphetamines or cocaine.
  7. Meets DSM-IV criteria for current substance dependence for drugs other than cannabis or nicotine.
  8. Currently meets full DSM-IV criteria for major depressive, manic, hypomanic, or mixed episode.
  9. Serious suicide or homicide risk, as assessed by evaluating clinician.
  10. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
  11. History of nephrolithiasis, or treatment with any drug associated with nephrolithiasis.
  12. Current treatment with zonisamide.
  13. Current treatment with any carbonic anhydrase inhibitors, including acetazolamide, dorzolamide, and methozolamide.
  14. Current treatment with any drug known to decrease drinking.
  15. Current psychosocial treatment (other than self-help groups) more than 1X/month. Psychosocial treatment is defined as individual or group psychotherapy (not including 12-step treatments such as AA or NA).
  16. Any psychotic disorder, including schizoaffective disorder (current or past).
  17. Clinical or laboratory evidence of untreated hypothyroidism.
  18. Patients with a diagnosis or history of glaucoma
  19. Patients requiring excluded medications (see table below for details).
  20. Psychotic features in the current episode or a history of a psychotic disorder, as assessed by SCID.
  21. Past intolerance to topiramate.
  22. Any use of topiramate in the past 12 months.
  23. Any investigational psychotropic drug within the last 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572117

Contacts
Contact: Michael J. Ostacher, MD, MPH 617-726-5258 mostacher@partners.org
Contact: Jonathan Stange 617-726-0997 jstange@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Bipolar Clinic and Research Program Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dr. Michael J. Ostacher, MD, MPH            
Principal Investigator: Michael J. Ostacher, MD, MPH            
Sponsors and Collaborators
Investigators
Principal Investigator: Michael J. Ostacher, MD, MPH Massachusetts General Hospital
  More Information

Massachusetts General Hospital Bipolar Clinic and Research Program  This link exits the ClinicalTrials.gov site

Responsible Party: Massachusetts General Hospital Bipolar Clinic and Research Program ( Michael J. Ostacher, MD, MPH, Principal Investigator )
Study ID Numbers: TIL-NIAAA-016340-01, NIH grant K23 A016340-01
Study First Received: December 10, 2007
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00572117  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Bipolar Disorder
Manic Disorder
Manic-Depressive
Alcoholism
Alcohol Abuse
Alcohol Dependence
Clinical Trial
Evaluation Trial
Intervention Trial
Validation Studies

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Alcoholism
Mood Disorders
Substance-Related Disorders
Topiramate
Disorders of Environmental Origin
Psychotic Disorders
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Anti-Obesity Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009