Substance AbusePhase 4SIPNCT01155544
Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
A Phase 4 study testing Behavioral Intervention in people with Substance Abuse and Substance Dependence, run by Northwell Health at 2 sites in United States.
Trial summary
This project focuses on the under-researched group of individuals who develop psychotic episodes of short duration (less than four weeks) while using substances. This includes individuals diagnosed with psychotic disorder not otherwise specified (PNOS) or substance-induced psychotic disorder (SIP) AND substance abuse… Read more about this study
- Who is it for?
- Ages 16 to 44 years
- Conditions the study is for
- Substance Abuse, Substance Dependence
- What is being tested?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Jun 2014
- 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 16 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- DSM-IV-defined diagnosis of psychosis NOS or substance-induced psychosis assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)
- onset of psychotic symptoms following onset of substance use
- current DSM-IV-defined diagnosis of substance abuse or dependence assessed with the SCID-I/P
- duration of the acute psychotic episode less than 4 weeks
- aged 16 to 44
- competent and willing to sign informed consent
- for women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control and not to become pregnant during the study
- at the entry of the maintenance phase, remission of psychotic symptoms defined as 1) simultaneous ratings of <3 ("mild) on all of the following Brief Psy¬chiatric Rating Scale-Anchored version items (BPRS-A; Woerner et al. 1988): suspiciousness, unusual thought content, hallucinations, conceptual disorganization; and 2) a Clinical Global Impressions Scale (CGI; Guy 1976) Se-verity rating of 3 ("mild") or less.
Who cannot join
- DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, shared psychotic disorder, or a major mood disorder (major depression or bipolar mania) with psychotic features
- antipsychotic treatment for more than six months prior to enrollment
- serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
- medical condition that requires treatment with a medication that has psychotropic effects
- significant risk of suicidal or homicidal ideation or behavior
- cognitive or language limitations, or any other factor that would preclude subjects providing informed consent or participating in study procedures
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- history of treatment resistance to aripiprazole
- medical contraindications to aripiprazole
- hypersensitivity to aripiprazole or any component of the products.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
North Shore Hospital
Manhasset, New York, 11030
About this study
This project focuses on the under-researched group of individuals who develop psychotic episodes of short duration (less than four weeks) while using substances. This includes individuals diagnosed with psychotic disorder not otherwise specified (PNOS) or substance-induced psychotic disorder (SIP) AND substance abuse or dependence. Very little is known about the most appropriate maintenance/relapse prevention management of these subjects. These individuals are not diagnosed with a primary psychosis because psychotic symptoms are too short-lived or non-specific, the onset of substance use precedes the onset of psychotic symptoms and the subject has not experienced sufficient psychotic symptoms in the absence of substance use. However, previous studies have shown that they are at high risk of recurrence of psychotic symptoms. Thus, this project will assess the efficacy of the second-generation antipsychotic aripiprazole for maintenance treatment of subjects who had a recent psychotic episode of short duration associated with substance use. The investigators will compare aripiprazole and placebo for preventing the recurrence of psychotic symptoms and decreasing substance use during a 6-month maintenance phase.
- Conditions
- Substance Abuse, Substance Dependence
- Being tested
- Behavioral Intervention
- Keywords
- Aripiprazole, Psychotic experiences, Substance abuse, Substance dependence, Craving, Mood, Substance use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Preventing recurrence of substance use.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Active comparator | Not described Receives: Behavioral: Behavioral Intervention |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic Symptoms
Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale. We will focus on time to first recurrence of psychotic symptoms and rate of recurrence.
Measured: 7 months
Frequency/amount of substance use
Frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method. We will focus on time to first recurrence of substance use and rate of recurrence.
Measured: 7 months
Secondary outcomes (2)
Mood symptoms
Mood symptoms will be assessed with the Hamilton Depression Rating Scale
Measured: 7 months
Adverse Events
Adverse events will be assessed with the Systematic Assessment for Treatment Emergent Events interview, Simpson-Angus Scale for Extrapyramidal Symptoms, the Abnormal Involuntary Movement Scale, the Barnes Akathisia Scale, and blood tests (fasting glucose, insulin and lipid profile tests)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2011
- Primary completionSep 2013 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: Seems to have simply stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Serge Sevy, MD, MBA, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155544
- Sponsor's protocol ID
- 10-160B
- Acronym
- SIP
- Status last verified
- Mar 2018
- First submitted
- 1 Jul 2010
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
- ClinicalTrials.gov ID
- NCT01155544
- Acronym / sponsor ID
- SIP / 10-160B
- Conditions
- Substance Abuse, Substance Dependence
- Keywords
- Aripiprazole, Psychotic experiences, Substance abuse, Substance dependence, Craving, Mood, Substance use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Seems to have simply stopped.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 2 Jul 2010 (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.
This project focuses on the under-researched group of individuals who develop psychotic episodes of short duration (less than four weeks) while using substances. This includes individuals diagnosed with psychotic disorder not otherwise specified (PNOS) or substance-induced psychotic disorder (SIP) AND substance abuse or dependence. Very little is known about the most appropriate maintenance/relapse prevention management of these subjects. These individuals are not diagnosed with a primary psychosis because psychotic symptoms are too short-lived or non-specific, the onset of substance use precedes the onset of psychotic symptoms and the subject has not experienced sufficient psychotic symptoms in the absence of substance use. However, previous studies have shown that they are at high risk of recurrence of psychotic symptoms. Thus, this project will assess the efficacy of the second-generation antipsychotic aripiprazole for maintenance treatment of subjects who had a recent psychotic episode of short duration associated with substance use. The investigators will compare aripiprazole and placebo for preventing the recurrence of psychotic symptoms and decreasing substance use during a 6-month maintenance phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Active comparator | Behavioral: Behavioral Intervention |
| Placebo | Placebo comparator | Behavioral: Behavioral Intervention |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- DSM-IV-defined diagnosis of psychosis NOS or substance-induced psychosis assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)
- onset of psychotic symptoms following onset of substance use
- current DSM-IV-defined diagnosis of substance abuse or dependence assessed with the SCID-I/P
- duration of the acute psychotic episode less than 4 weeks
- aged 16 to 44
Key exclusion criteria (9 listed)
- DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, shared psychotic disorder, or a major mood disorder (major depression or bipolar mania) with psychotic features
- antipsychotic treatment for more than six months prior to enrollment
- serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
- medical condition that requires treatment with a medication that has psychotropic effects
- significant risk of suicidal or homicidal ideation or behavior
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 |
|---|---|---|
| Behavioral InterventionPreventing recurrence of substance use. | Behavioural | Aripiprazole, Placebo |
Primary outcome
Psychotic Symptoms
Time frame: 7 months
Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale. We will focus on time to first recurrence of psychotic symptoms and rate of recurrence.
Frequency/amount of substance use
Time frame: 7 months
Frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method. We will focus on time to first recurrence of substance use and rate of recurrence.
2 secondary outcomes
Mood symptoms
Time frame: 7 months
Adverse Events
Time frame: 7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
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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.
Serge Sevy, MD, MBA principal investigator
Feinstein Institute for Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Behavioral Intervention in people with Substance Abuse and Substance Dependence, run by Northwell Health at 2 sites 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 8 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: withdrawn, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Psychotic Symptoms (time frame: 7 months). The study lists 2 primary outcomes in all. 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 19 Mar 2018.