Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study

April 18, 2007 updated by: Veterans Medical Research Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an 8 week open label trial being conducted in stable adult outpatients with schizophrenia who are smokers. The primary intervention is a switch in the subject's antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum glucose and lipids, rating of symptom severity using the PANSS, and both ratings and instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to obtain the needed 15 completers at the week 8 endpoint.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Treatment refractory schizophrenia
  3. Current treatment with clozapine
  4. Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
  5. Documented poor compliance with oral antipsychotic medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Saliva cotinine, Fagerstrom Test for Nicotine Dependence

Secondary Outcome Measures

Outcome Measure
Weight
Serum glucose and lipids
Rating of symptom severity using the PANSS
Ratings and instrumental measures of motor functioning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Medical Research Foundation

Investigators

  • Principal Investigator: Jonathan M Meyer, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

April 19, 2007

Last Update Submitted That Met QC Criteria

April 18, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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