NCT00167817

Brief Summary

Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. The primary purpose of the present study is to investigate whether switching patients with schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of action, will have an impact on smoking behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

September 10, 2005

Last Update Submit

April 18, 2007

Conditions

Schizophrenia

Keywords

SchizophreniaSmokingMetabolicHealthGlucoseLipids

Outcome Measures

Primary Outcomes (1)

  • Saliva cotinine, Fagerstrom Test for Nicotine Dependence

Secondary Outcomes (4)

  • Weight

  • Serum glucose and lipids

  • Rating of symptom severity using the PANSS

  • Ratings and instrumental measures of motor functioning

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia, on stable antipsychotic dose for at least one month
  • Ages 18-65 inclusive
  • Overweight (body mass index of 25 kg/m2 or greater)
  • Daily cigarette smoker (by self-report)

You may not qualify if:

  • Inability to provide informed consent
  • Treatment refractory schizophrenia
  • Current treatment with clozapine
  • Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
  • Documented poor compliance with oral antipsychotic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

SchizophreniaSmoking

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jonathan M Meyer, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 14, 2005

Study Start

July 1, 2003

Study Completion

September 1, 2005

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

US(1)