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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Ostacher, Stanford University
ClinicalTrials.gov Identifier:
NCT00572117
First received: December 10, 2007
Last updated: December 12, 2012
Last verified: December 2012
  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
Alcoholism
Alcohol Dependence
Drug: Topiramate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Stanford University:

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 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Drug: 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.
Other Name: Topamax
Experimental: 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.
Drug: 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.
Other Name: Topamax

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 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 methazolamide.
  14. Current treatment with any drug known to decrease drinking.
  15. Subjects who have begun a new psychosocial treatment within 12 weeks of study enrollment. Subjects receiving psychosocial treatment that has been stable for at least 12 weeks prior to study entry, however, will be permitted to enroll in the study.
  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572117

Contacts
Contact: Michael J. Ostacher, MD, MPH 650-493-5000 ext 60494 ostacher@stanford.edu
Contact: Iola Gwizdowski 617-493-5000 ext 67571 Iola.Gwizdowski@va.gov

Locations
United States, California
Stanford/VA Palo Alto Mood Disorder Research Program Recruiting
Palo Alto, California, United States, 94304
Contact: Michael J. Ostacher, MD, MPH         
Principal Investigator: Michael J. Ostacher, MD, MPH         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Michael J. Ostacher, MD, MPH Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Ostacher, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00572117     History of Changes
Other Study ID Numbers: TIL-NIAAA-016340-01, K23AA016340
Study First Received: December 10, 2007
Last Updated: December 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Bipolar Disorder
Manic Disorder
Alcoholism
Alcohol Abuse
Alcohol Dependence
Clinical Trial
Evaluation Trial
Intervention Trial
Validation Studies

Additional relevant MeSH terms:
Alcoholism
Bipolar Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 24, 2014