Abilify Therapy for Reducing Comorbid Substance Abuse
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Purpose
It is hypothesized that the use of aripiprazole (Abilify) in patients with alcohol and/or drug dependence with comorbid psychiatric conditions will lead to:
- Reduction in the amount of alcohol and/or 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Anxiety Disorders Substance Abuse |
Drug: Aripiprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse |
- The primary outcome measure will be days of abstinence during the 12-week follow-up, as measured by the Time Line Follow Back Scale (TLFBS) and the Addiction Severity Index (ASI). [ Time Frame: Two years ]
- Secondary outcome measures will assess severity of symptoms as measured by the Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Scale (HAM-A), Young Mania Rating Scale (YMRS), and the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Two years ]
- The Penn Alcohol Craving Scale will also be used. [ Time Frame: Two years ]
| Enrollment: | 30 |
| Study Start Date: | March 2005 |
| Study Completion Date: | June 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
Drug: 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.
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Ages 19 - 65
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or anxiety (panic disorder, generalized anxiety disorder, or post-traumatic stress disorder) as confirmed by Mini International Neuropsychiatric Interview (MINI) structured assessment
- Diagnosis of comorbid substance abuse/dependence as confirmed by the MINI structured assessment
- Ability to provide signed informed consent
- Stable general medical health
- Ability to attend outpatient research clinic.
Exclusion Criteria:
- Dangerous to self or others
- Pregnancy, or inability or unwillingness to use approved methods of birth control
- Inability or unwillingness to provide signed informed consent
- Inability to attend outpatient research clinic
- Medical conditions, which would preclude use of aripiprazole
- Absolute need for ongoing treatment with antipsychotic other than aripiprazole
- Medical instability defined as likelihood of needing to change prescription medication during the course of the study
- Patients with prior unsuccessful treatment with aripiprazole
- Patients with a psychiatric diagnosis of only antisocial personality disorder or only an eating disorder and comorbid substance abuse/dependence.
Contacts and Locations| United States, Nebraska | |
| Creighton University Psychiatry and Research Center | |
| Omaha, Nebraska, United States, 68131 | |
| Principal Investigator: | Pirzada S. Sattar, M.D. | Creighton University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00208169 History of Changes |
| Other Study ID Numbers: | 05-13685 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 22, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Creighton University:
|
Comorbid substance abuse/dependence Comorbid diagnoses Substance abuse and/or dependence |
Additional relevant MeSH terms:
|
Anxiety Disorders Bipolar Disorder Depressive Disorder Depression Psychotic Disorders Schizophrenia Depressive Disorder, Major Substance-Related Disorders Mental Disorders Affective Disorders, Psychotic Mood Disorders |
Behavioral Symptoms Schizophrenia and Disorders with Psychotic Features Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013