Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

Substance Abuse Clinical Trial

— SIP  

Official title:

Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01155544
• Other study ID #: 10-160B
• Status: Withdrawn
• Phase: Phase 4
• First received: July 1, 2010
• Last updated: March 15, 2018
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Abuse
• Substance Dependence
• Substance-Related Disorders

Intervention

Behavioral:
• Behavioral Intervention
Preventing recurrence of substance use.

Locations

Country	Name	City	State
United States	The Zucker Hillside Hospital	Glen Oaks	New York
United States	North Shore Hospital	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 months
Primary	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.	7 months
Secondary	Mood symptoms	Mood symptoms will be assessed with the Hamilton Depression Rating Scale	7 months
Secondary	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)	7 months