Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208169
Status:
COMPLETED
Last Update Posted:
2007-08-24
First Post:
2005-09-13
Brief Title:
Abilify Therapy for Reducing Comorbid Substance Abuse
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Aripiprazole Abilify Therapy for Reducing Comorbid Substance Abuse
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is hypothesized that the use of aripiprazole Abilify in patients with alcohol andor drug dependence with comorbid psychiatric conditions will lead to
Reduction in the amount of alcohol andor drugs used as measured by the Time Line Follow Back TLFB and the Addiction Severity Index ASI
Reduction in cravings for alcohol and drugs as measured by the Penn Alcohol Craving Scale
Reduction in symptoms of co-morbid psychiatric disorders compared to before starting aripiprazole
Reduction in the amount of alcohol andor drugs used as measured by the Time Line Follow Back TLFB and the Addiction Severity Index ASI
Reduction in cravings for alcohol and drugs as measured by the Penn Alcohol Craving Scale
Reduction in symptoms of co-morbid psychiatric disorders compared to before starting aripiprazole
Detailed Description:
Substance abuse disorders are a major public health problem With a current prevalence rate of 18 substance abuse and dependence costs the nation over 300 billion per year in treatment costs and lost productivity Approximately 20 of all patients attending primary care clinics and 35 of all patients attending psychiatric clinics meet Diagnostic and Statistical Manual IV DSM IV criteria for substance abuse or dependence
The treatment of substance abuse and dependence disorders is complex and involves individual and group therapy maintenance of sobriety commitment to structured living and participation in self-help groups To date pharmacotherapy for substance dependence disorders has had limited success Several medications have been tested in the past including tricyclic antidepressants selective serotonin reuptake inhibitors buspirone bupropion venlafaxine nefazodone bromocriptine amantadine naltrexone and acamprosate Of these naltrexone has obtained an FDA indication for treatment of alcohol dependence and acamprosate is in use in Europe However these medications are effective in only a relatively small proportion of patients Benzodiazepines may be useful in treatment of withdrawal syndromes but their potential for abuse and dependence limits their use in maintenance treatment
This is an open label pilot study of aripiprazole therapy in the treatment of patients with substance use disorders and co-morbid disorders like Schizophrenia Schizoaffective disorder Bipolar disorder Major depressive disorder Anxiety Panic disorder Generalized Anxiety Disorder Post-Traumatic Stress Disorder While Aripiprazole has been approved for the treatment of Schizophrenia its use in other psychiatric disorders is off label use Increasing evidence suggests that Aripiprazole might offer some benefit for other psychiatric disorders besides Schizophrenia
The treatment of substance abuse and dependence disorders is complex and involves individual and group therapy maintenance of sobriety commitment to structured living and participation in self-help groups To date pharmacotherapy for substance dependence disorders has had limited success Several medications have been tested in the past including tricyclic antidepressants selective serotonin reuptake inhibitors buspirone bupropion venlafaxine nefazodone bromocriptine amantadine naltrexone and acamprosate Of these naltrexone has obtained an FDA indication for treatment of alcohol dependence and acamprosate is in use in Europe However these medications are effective in only a relatively small proportion of patients Benzodiazepines may be useful in treatment of withdrawal syndromes but their potential for abuse and dependence limits their use in maintenance treatment
This is an open label pilot study of aripiprazole therapy in the treatment of patients with substance use disorders and co-morbid disorders like Schizophrenia Schizoaffective disorder Bipolar disorder Major depressive disorder Anxiety Panic disorder Generalized Anxiety Disorder Post-Traumatic Stress Disorder While Aripiprazole has been approved for the treatment of Schizophrenia its use in other psychiatric disorders is off label use Increasing evidence suggests that Aripiprazole might offer some benefit for other psychiatric disorders besides Schizophrenia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None