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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Study Start Date : July 2003
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Saliva cotinine, Fagerstrom Test for Nicotine Dependence

Secondary Outcome Measures :
  1. Weight
  2. Serum glucose and lipids
  3. Rating of symptom severity using the PANSS
  4. Ratings and instrumental measures of motor functioning

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167817

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United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
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Principal Investigator: Jonathan M Meyer, MD University of California, San Diego

Layout table for additonal information Identifier: NCT00167817     History of Changes
Other Study ID Numbers: 030762
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007
Keywords provided by Veterans Medical Research Foundation:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists