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Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence

Primary Purpose

Alcohol Dependence, Borderline Personality Disorder

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Topiramate
Sponsored by
Elizabeth Ralevski
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Treatment, Topiramate, Alcohol Dependence, Borderline Personality Disorder

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of AD
  • Diagnosis of BPD

Exclusion Criteria:

  • Serious or unstable medical condition
  • Opiate dependence
  • Major Axis I disorder (bipolar disorder, schizophrenia)
  • Taking mood stabilizers and antipsychotic medications
  • LFT abnormalities that do not exceed 3 times normal values

Sites / Locations

    Outcomes

    Primary Outcome Measures

    drinking - measured using the TLFB
    craving - measured using the OCDS
    aggression - measured using the STAE

    Secondary Outcome Measures

    affect - measured using the Buss-Durkee Scale and Affective Intensity Scale
    side effects - measured using the SAFTEE

    Full Information

    First Posted
    April 18, 2007
    Last Updated
    January 26, 2012
    Sponsor
    Elizabeth Ralevski
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00463775
    Brief Title
    Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
    Official Title
    Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Recruitment not progressing as planned.
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Elizabeth Ralevski

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the present study is to evaluate the efficacy of topiramate (250mg/day) versus placebo in decreasing aggression and reducing alcohol consumption in patients with borderline personality disorder (BPD) and alcohol dependence (AD).
    Detailed Description
    Background: Borderline personality disorder (BPD) affects about 2% of the American adult population. It is a very serious psychiatric disorder that places heavy demands on mental health resources. Behavior dysregulation (impulsivity, self-injurious acts, drinking or aggressive behavior) is considered one of the main features of BPD and is associated with significant clinical morbidity. Alcohol abuse is common among patients with BPD, and the co-morbid rates of alcoholism in BPD patients are estimated to be 30%. It has been hypothesized that alcohol misuse may be a manifestation of BPD's behavioral dysregulation. Also, BPD and alcohol dependence (AD) share a common underlying neurobiology. The co-occurrence of these disorders has been associated with increased rates of alcohol relapse, impulsive behaviors, greater resistance to treatment, and suicidal behavior. Effective treatment for patients with BPD and AD would result in markedly reduced health care costs and a substantial reduction in human distress and suffering. Despite dramatic advances in the treatment of BPD, to date, no single medication or types of medications have been uniquely identified as effective in treating BPD. Studies treating patients with co-morbid BPD and AD are expressly lacking. Research Design and Methodology: This is an 8-week double-blind outpatient clinical trial of oral topiramate (250mg) vs placebo in individuals with BPD and AD. The study will be conducted at the West Haven, CT VA. Thirty men and women with a current diagnosis of BPD and AD will be enrolled. The State-Trait Anger Expression Inventory (STAEI) will be used to assess 5 aspects of aggression: state anger, trait anger, anger expressed inwardly, anger expressed outwardly, and anger control before and during treatment (weeks 0-8). The Timeline Follow-Back (TLFB) method will be used to document the degree of daily alcohol consumption before and during treatment (90 days before treatment, and weeks 0 - 8). Emergent side effects will be assessed using the modified version of the Systematic Assessment for Treatment Emergent Events (SAFTEE).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Dependence, Borderline Personality Disorder
    Keywords
    Treatment, Topiramate, Alcohol Dependence, Borderline Personality Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Topiramate
    Intervention Description
    SSRI plus topiramate SSRI plus placebo
    Primary Outcome Measure Information:
    Title
    drinking - measured using the TLFB
    Time Frame
    12 weeks
    Title
    craving - measured using the OCDS
    Time Frame
    12 weeks
    Title
    aggression - measured using the STAE
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    affect - measured using the Buss-Durkee Scale and Affective Intensity Scale
    Time Frame
    12 weeks
    Title
    side effects - measured using the SAFTEE
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of AD Diagnosis of BPD Exclusion Criteria: Serious or unstable medical condition Opiate dependence Major Axis I disorder (bipolar disorder, schizophrenia) Taking mood stabilizers and antipsychotic medications LFT abnormalities that do not exceed 3 times normal values
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Ralevski, Ph.D.
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36375174
    Citation
    Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
    Results Reference
    derived

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    Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence

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