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Sponsors and Collaborators: |
Creighton University Bristol-Myers Squibb |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00208169 |
It is hypothesized that the use of aripiprazole (Abilify) in patients with alcohol and/or drug dependence with comorbid psychiatric conditions will lead to:
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Anxiety Disorders Substance Abuse |
Drug: Aripiprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse |
Enrollment: | 30 |
Study Start Date: | March 2005 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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1: Experimental
Aripiprazole start dose at 5 mg/day by day 4-6 increase to 10 mg/da and day 7 and subsequent visits flexible dosing from 10 up to 30 mg/day.
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Drug: Aripiprazole |
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.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
Creighton University Psychiatry and Research Center | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Pirzada S. Sattar, M.D. | Creighton University |
Study ID Numbers: | 05-13685 |
Study First Received: | September 13, 2005 |
Last Updated: | August 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00208169 History of Changes |
Health Authority: | United States: Institutional Review Board |
Comorbid substance abuse/dependence Comorbid diagnoses Substance abuse and/or dependence |
Tranquilizing Agents Depression Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Disorders of Environmental Origin Depressive Disorder, Major Antipsychotic Agents Depressive Disorder Behavioral Symptoms |
Schizophrenia Affective Disorders, Psychotic Anxiety Disorders Mental Disorders Substance-Related Disorders Mood Disorders Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features |
Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Depressive Disorder, Major Schizophrenia Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Substance-Related Disorders Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features |
Disease Depression Tranquilizing Agents Bipolar Disorder Central Nervous System Depressants Depressive Disorder Antipsychotic Agents Pharmacologic Actions Behavioral Symptoms Anxiety Disorders Mood Disorders Central Nervous System Agents |