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Abilify Therapy for Reducing Comorbid Substance Abuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208169
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 24, 2007
Bristol-Myers Squibb
Information provided by:
Creighton University

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse
Study Start Date : March 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. The Penn Alcohol Craving Scale will also be used. [ Time Frame: Two years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Ages 19 - 65
  2. 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
  3. Diagnosis of comorbid substance abuse/dependence as confirmed by the MINI structured assessment
  4. Ability to provide signed informed consent
  5. Stable general medical health
  6. Ability to attend outpatient research clinic.

Exclusion Criteria:

  1. Dangerous to self or others
  2. Pregnancy, or inability or unwillingness to use approved methods of birth control
  3. Inability or unwillingness to provide signed informed consent
  4. Inability to attend outpatient research clinic
  5. Medical conditions, which would preclude use of aripiprazole
  6. Absolute need for ongoing treatment with antipsychotic other than aripiprazole
  7. Medical instability defined as likelihood of needing to change prescription medication during the course of the study
  8. Patients with prior unsuccessful treatment with aripiprazole
  9. Patients with a psychiatric diagnosis of only antisocial personality disorder or only an eating disorder and comorbid substance abuse/dependence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208169

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United States, Nebraska
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Bristol-Myers Squibb
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Principal Investigator: Pirzada S. Sattar, M.D. Creighton University

Layout table for additonal information Identifier: NCT00208169    
Other Study ID Numbers: 05-13685
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 24, 2007
Last Verified: August 2007
Keywords provided by Creighton University:
Comorbid substance abuse/dependence
Comorbid diagnoses
Substance abuse and/or dependence
Additional relevant MeSH terms:
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Substance-Related Disorders
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Anxiety Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Bipolar and Related Disorders
Chemically-Induced Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists