Alcohol Dependence Clinical Trial
Official title:
Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
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).
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03340051 -
Remote Alcohol Monitoring and Episodic Thinking
|
N/A | |
Completed |
NCT02901041 -
Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
|
Phase 3 | |
Completed |
NCT02486900 -
Neurofeedback & Alcohol Dependence
|
N/A | |
Completed |
NCT02705898 -
Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women
|
N/A | |
Completed |
NCT02197598 -
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
|
Phase 4 | |
Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
Recruiting |
NCT02385643 -
The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
|
N/A | |
Completed |
NCT01828866 -
Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Active, not recruiting |
NCT01182766 -
New Treatment for Alcohol and Nicotine Dependence
|
Phase 2/Phase 3 | |
Completed |
NCT02193204 -
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
|
N/A | |
Completed |
NCT01342549 -
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
|
Phase 3 | |
Completed |
NCT01165541 -
A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
|
Phase 2 | |
Completed |
NCT01176591 -
HBPL Study of the Impact of the NK1 Antagonist Aprepitant
|
Phase 2 | |
Completed |
NCT00585780 -
Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
|
Phase 1/Phase 2 | |
Completed |
NCT01056484 -
Mindfulness Meditation for Health
|
Phase 2 | |
Completed |
NCT00607620 -
Disseminating Organizational SBI Services at Trauma Centers
|
N/A | |
Completed |
NCT00884884 -
Aripiprazole and Topiramate on Free-Choice Alcohol Use
|
Phase 2/Phase 3 | |
Completed |
NCT00463346 -
Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
|
Phase 3 | |
Completed |
NCT00226694 -
Alcohol and Gender Effects on Stress Circuit Function
|
N/A |