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Withdrawn Phase 4 Interventional

Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

ClinicalTrials.gov ID: NCT01155544

Public ClinicalTrials.gov record NCT01155544. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 19, 2026, 12:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01155544
Recruitment status
Withdrawn
Study type
Interventional
Phase
Phase 4
Lead sponsor
Northwell Health
Other
Enrollment
Not listed

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
16 Years to 44 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2011
Primary completion
Aug 31, 2013
Completion
May 31, 2014
Last update posted
Mar 18, 2018

2011 – 2014

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
The Zucker Hillside Hospital Glen Oaks New York 11004
North Shore Hospital Manhasset New York 11030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01155544, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 18, 2018 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01155544 live on ClinicalTrials.gov.

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