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

Primary Purpose

Substance Abuse, Substance Dependence

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Behavioral Intervention

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Aripiprazole, Psychotic experiences, Substance abuse, Substance dependence, Craving, Mood, Substance use

Eligibility Criteria

16 Years - 44 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

The Zucker Hillside Hospital
North Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aripiprazole

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Mood symptoms

Mood symptoms will be assessed with the Hamilton Depression Rating Scale

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)

Full Information

NCT ID

NCT01155544

First Posted

July 1, 2010

Last Updated

March 15, 2018

Sponsor

Northwell Health

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01155544

Brief Title

Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

Acronym

SIP

Official Title

Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Seems to have simply stopped.

Study Start Date

June 2011 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Abuse, Substance Dependence

Keywords

Aripiprazole, Psychotic experiences, Substance abuse, Substance dependence, Craving, Mood, Substance use

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aripiprazole

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Intervention

Intervention Description

Preventing recurrence of substance use.

Primary Outcome Measure Information:

Title

Psychotic Symptoms

Description

Time Frame

7 months

Title

Frequency/amount of substance use

Description

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.

Time Frame

7 months

Secondary Outcome Measure Information:

Title

Mood symptoms

Description

Mood symptoms will be assessed with the Hamilton Depression Rating Scale

Time Frame

7 months

Title

Adverse Events

Description

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

44 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Serge Sevy, MD, MBA

Organizational Affiliation

Feinstein Institute for Medical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Zucker Hillside Hospital

City

Glen Oaks

State/Province

New York

ZIP/Postal Code

11004

Country

United States

Facility Name

North Shore Hospital

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

12. IPD Sharing Statement

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Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

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