Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole (SIP)
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ClinicalTrials.gov Identifier: NCT01155544 |
Recruitment Status
:
Withdrawn
(Seems to have simply stopped.)
First Posted
: July 2, 2010
Last Update Posted
: March 19, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Substance Abuse Substance Dependence | Behavioral: Behavioral Intervention | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | September 2013 |
Estimated Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Aripiprazole |
Behavioral: Behavioral Intervention
Preventing recurrence of substance use.
|
Placebo Comparator: Placebo |
Behavioral: Behavioral Intervention
Preventing recurrence of substance use.
|
- 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.
- Mood symptoms [ Time Frame: 7 months ]Mood symptoms will be assessed with the Hamilton Depression Rating Scale
- Adverse Events [ Time Frame: 7 months ]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)

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Ages Eligible for Study: | 16 Years to 44 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- history of treatment resistance to aripiprazole
- medical contraindications to aripiprazole
- hypersensitivity to aripiprazole or any component of the products.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155544
United States, New York | |
The Zucker Hillside Hospital | |
Glen Oaks, New York, United States, 11004 | |
North Shore Hospital | |
Manhasset, New York, United States, 11030 |
Principal Investigator: | Serge Sevy, MD, MBA | Feinstein Institute for Medical Research |
Responsible Party: | Northwell Health |
ClinicalTrials.gov Identifier: | NCT01155544 History of Changes |
Other Study ID Numbers: |
10-160B |
First Posted: | July 2, 2010 Key Record Dates |
Last Update Posted: | March 19, 2018 |
Last Verified: | March 2018 |
Keywords provided by Northwell Health:
Aripiprazole Psychotic experiences Substance abuse Substance dependence |
Craving Mood Substance use |
Additional relevant MeSH terms:
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Aripiprazole Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |