Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole (SIP)

Northwell Health

Status and phase

Withdrawn

Phase 4

Conditions

Substance Dependence

Substance Abuse

Treatments

Behavioral: Behavioral Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01155544

10-160B

Details and patient eligibility

About

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.

Sex

All

Ages

16 to 44 years old

Volunteers

No Healthy Volunteers

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.