Abilify Therapy for Reducing Comorbid Substance Abuse

Schizophrenia Clinical Trial

Official title:

Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208169
• Other study ID #: 05-13685
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 22, 2007
• Start date: March 2005
• Est. completion date: June 2007

Study information

• Verified date: August 2007
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Substance Abuse
• Substance-Related Disorders

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
United States	Creighton University Psychiatry and Research Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Two years
Secondary	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)		Two years
Secondary	The Penn Alcohol Craving Scale will also be used.		Two years