SchizophreniaPhase 2NCT00737256
A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
A Phase 2 study testing Aripiprazole and Perphenazine in people with Schizophrenia and Cocaine Dependence, run by Paul Saenger at 1 site in United States.
Trial summary
The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Cocaine Dependence
- What is being tested?
- Aripiprazole and Perphenazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2014
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder
- Have a DSM-IV diagnosis of current cocaine dependence.
- Are capable of reading, comprehending, and signing informed consent.
- Agree to take Aripiprazole or Perphenazine as treatment for SCHZ and CD.
- Agree to stop taking any other antipsychotic medication
- If female and of child bearing potential (WOCBP) agree to use an acceptable form of birth control and have a negative pregnancy test within 2 days prior to starting study medication
Who cannot join
- Under 18 years old or over 65 years old.
- Refusal or inability to give informed consent,
- Have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension (dehydration, hypovolemia),
- A history of seizures or conditions that lower the seizure threshold
- Have current suicidal ideation (history of suicide attempt in past 60 days)
- Are actively psychotic which in the opinion of the investigator would preclude proper informed consenting or protocol adherence
Show all 14Show fewer
- Are receiving or plan to receive an agent metabolized by the Cytochrome P450-3A4 or -2D6 systems, including carbamazepine, ketoconazole, quinidine, fluoxetine, and paroxetine
- WOCBP not on, or do not agree to use an acceptable form of contraception
- Known sensitivity to aripiprazole or perphenazine
- A diagnosis of current or past tardive dyskinesia
- Pending legal charges or a court mandate for drug treatment
- Currently taking concomitant medications that have been shown to reduce cocaine use, such as disulfiram
- Clinically significant liver function abnormalities
- Currently receiving depot neuroleptics
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veteran's Affairs Medical Center
Denver, Colorado, 80220
Lori Clapp, RN, MS, 720-854-4200
About this study
The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. Since aripiprazole has established effects against schizophrenia, the study focuses on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm of the study will give fewer cocaine positive urine specimens as compared to the perphenazine control arm.
- Conditions
- Schizophrenia, Cocaine Dependence
- Being tested
- Aripiprazole, Perphenazine
- Medical subject headings
- Schizophrenia, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
15-30 mg
PerphenazineDrug
8-16 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Aripiprazole |
| 2 | Active comparator | Not described Receives: Drug: Perphenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of negative urine drug screen results will be significantly greater in the subjects treated with aripiprazole than in those treated with perphenazine.
Measured: Week 3 and Week 8 of study participation
Secondary outcomes (2)
The mean total self-report cocaine use days will be significantly fewer in subjects treated with aripiprazole than in those treated with perphenazine.
Measured: End of study participation
The mean cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine.
Measured: End of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2013 (estimated)
- Study completionMay 2014 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Saenger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Saenger, Denver Research Institute
- Investigators
- Thomas P Beresford, MD, Principal investigator, Denver Veteran's Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737256
- Sponsor's protocol ID
- 07-0124
- Status last verified
- Sep 2012
- First submitted
- 14 Aug 2008
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00737256
- Acronym / sponsor ID
- 07-0124
- Conditions
- Schizophrenia, Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Paul SaengerUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 18 Aug 2008 (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.
The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. Since aripiprazole has established effects against schizophrenia, the study focuses on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm of the study will give fewer cocaine positive urine specimens as compared to the perphenazine control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aripiprazole |
| 2 | Active comparator | Drug: Perphenazine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder
- Have a DSM-IV diagnosis of current cocaine dependence.
- Are capable of reading, comprehending, and signing informed consent.
- Agree to take Aripiprazole or Perphenazine as treatment for SCHZ and CD.
- Agree to stop taking any other antipsychotic medication
Key exclusion criteria (14 listed)
- Under 18 years old or over 65 years old.
- Refusal or inability to give informed consent,
- Have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension (dehydration, hypovolemia),
- A history of seizures or conditions that lower the seizure threshold
- Have current suicidal ideation (history of suicide attempt in past 60 days)
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 |
|---|---|---|
| Aripiprazole15-30 mg | Drug | 1 |
| Perphenazine8-16 mg | Drug | 2 |
Primary outcome
The proportion of negative urine drug screen results will be significantly greater in the subjects treated with aripiprazole than in those treated with perphenazine.
Time frame: Week 3 and Week 8 of study participation
2 secondary outcomes
The mean total self-report cocaine use days will be significantly fewer in subjects treated with aripiprazole than in those treated with perphenazine.
Time frame: End of study participation
The mean cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine.
Time frame: End of study participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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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.
Thomas P Beresford, MD principal investigator
Denver Veteran's Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aripiprazole and Perphenazine in people with Schizophrenia and Cocaine Dependence, run by Paul Saenger 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 14 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: status not confirmed, as of the sponsor's last update on 7 Sep 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ratzlaff, MA (303-399-8020 ext. 3855, Jennifer.Ratzlaff@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of negative urine drug screen results will be significantly greater in the subjects treated with aripiprazole than in those treated with perphenazine. (time frame: Week 3 and Week 8 of study participation). 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 7 Sep 2012.