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

NCT00572117 | Completed Phase 4 Results

• 2 other identifiers: TIL-NIAAA-016340-01K23AA016340
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Alcoholism; Alcohol Dependence

Keywords

Bipolar Disorder; Manic Disorder; Alcoholism; Alcohol Abuse; Alcohol Dependence; Clinical Trial; Evaluation Trial; Intervention Trial; Validation Studies

Outcome Measures

Primary Outcomes (1)

• Amount of Alcohol Consumed

  Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Effect of Treatment on Mood Symptoms

  Baseline and 12 weeks

Study Arms (2)

Placebo (inert pill) Arm

PLACEBO COMPARATOR

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

Topiramate

EXPERIMENTAL

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

Interventions

Topiramate DRUG

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.

Also known as: Topamax

Placebo (inert pill) Arm; Topiramate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Written informed consent.
• Meet DSM-IV criteria (by SCID) for alcohol dependence.
• Meet DSM-IV criteria (by SCID) for bipolar disorder I or II disorder.
• ≥ 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.
• 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.
• Antidepressant treatment is permitted if the dose has been stable for the past 4 weeks.

You may not qualify if:

• 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.
• Women who are lactating.
• Age under 18.
• Patients who do not have ≥ 8 heavy drinking days in the 4 weeks prior to the baseline visit.
• Important alcohol withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol-Revised, CIWA-Ar, score \> 15)
• Urine toxicological screen positive for amphetamines or cocaine.
• Meets DSM-IV criteria for current substance dependence for drugs other than cannabis or nicotine.
• Currently meets full DSM-IV criteria for manic, hypomanic, or mixed episode.
• Serious suicide or homicide risk, as assessed by evaluating clinician.
• Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
• History of nephrolithiasis, or treatment with any drug associated with nephrolithiasis.
• Current treatment with zonisamide.
• Current treatment with any carbonic anhydrase inhibitors, including acetazolamide, dorzolamide, and methazolamide.
• Current treatment with any drug known to decrease drinking.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Stanford/VA Palo Alto Mood Disorder Research Program

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcoholism

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Michael J. Ostacher, MD, MPH, MMSc
• Organization: Stanford University School of Medicine

ostacher@stanford.edu

650-493-5000

Study Officials

• Michael J. Ostacher, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)