Clinical trial NCT01155544: Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
Official title: Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Substance Abuse
Substance Dependence
Keywords: Aripiprazole
Psychotic experiences
Substance abuse
Substance dependence
Craving
Mood
Substance use
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Psychotic Symptoms
timeFrame: 7 months
measure: Frequency/amount of substance use
timeFrame: 7 months
Secondary outcomes:
measure: Mood symptoms
timeFrame: 7 months
measure: Adverse Events
timeFrame: 7 months
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore Hospital
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Serge Sevy, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: