Abilify Therapy for Reducing Comorbid Substance Abuse
|ClinicalTrials.gov Identifier: NCT00208169|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 24, 2007
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 or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Anxiety Disorders Substance Abuse||Drug: Aripiprazole||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||June 2007|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208169
|United States, Nebraska|
|Creighton University Psychiatry and Research Center|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Pirzada S. Sattar, M.D.||Creighton University|