SchizophreniaPhase 4NCT00208169
Abilify Therapy for Reducing Comorbid Substance Abuse
A Phase 4 study testing Aripiprazole in people with Schizophrenia and Schizoaffective Disorder, run by Creighton University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Psychiatry and Research Center
Omaha, Nebraska, 68131
About this study
Official title: Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Anxiety Disorders, Substance Abuse
- Being tested
- Aripiprazole
- Keywords
- Comorbid substance abuse/dependence, Comorbid diagnoses, Substance abuse and/or dependence
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major, Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Two years
The Penn Alcohol Craving Scale will also be used.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Pirzada S. Sattar, M.D., Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208169
- Sponsor's protocol ID
- 05-13685
- Status last verified
- Aug 2007
- First submitted
- 13 Sep 2005
- Last updated
- 24 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole (Abilify) Therapy for Reducing Comorbid Substance Abuse
- ClinicalTrials.gov ID
- NCT00208169
- Acronym / sponsor ID
- 05-13685
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Anxiety Disorders, Substance Abuse
- Keywords
- Comorbid substance abuse/dependence, Comorbid diagnoses, Substance abuse and/or dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AripiprazoleAripiprazole 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole | Drug | 1 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirzada S. Sattar, M.D. principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Schizophrenia and Schizoaffective Disorder, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2007.