Abilify Therapy for Reducing Comorbid Substance Abuse

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00208169
First received: September 13, 2005
Last updated: August 22, 2007
Last verified: August 2007
  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

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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:
  • 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
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208169

Locations
United States, Nebraska
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Bristol-Myers Squibb
Investigators
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 July 28, 2014