NCT00208169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 24, 2007

Status Verified

August 1, 2007

First QC Date

September 13, 2005

Last Update Submit

August 22, 2007

Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderAnxiety DisordersSubstance Abuse

Keywords

Comorbid substance abuse/dependenceComorbid diagnosesSubstance abuse and/or dependence

Outcome Measures

Primary Outcomes (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).

    Two years

Secondary Outcomes (2)

  • 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

  • The Penn Alcohol Craving Scale will also be used.

    Two years

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

AripiprazoleDRUG
1

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Psychiatry and Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderDepressive Disorder, MajorAnxiety DisordersSubstance-Related Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive DisorderChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pirzada S. Sattar, M.D.

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2005

Study Completion

June 1, 2007

Last Updated

August 24, 2007

Record last verified: 2007-08

Locations

US(1)