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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167817
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 19, 2007
Information provided by:
Veterans Medical Research Foundation

September 10, 2005
September 14, 2005
April 19, 2007
July 2003
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Saliva cotinine, Fagerstrom Test for Nicotine Dependence
Same as current
Complete list of historical versions of study NCT00167817 on Archive Site
  • Weight
  • Serum glucose and lipids
  • Rating of symptom severity using the PANSS
  • Ratings and instrumental measures of motor functioning
Same as current
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Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
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.
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.
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Aripiprazole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Veterans Medical Research Foundation
Not Provided
Principal Investigator: Jonathan M Meyer, MD University of California, San Diego
Veterans Medical Research Foundation
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP