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Completed

NCT Number: NCT00167817

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.

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Key information

Conditions

Schizophrenia Behavior Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Smoking

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Aripiprazole

Drug

Primary outcomes

  1. Saliva cotinine, Fagerstrom Test for Nicotine Dependence

Secondary outcomes

  1. Weight

  2. Serum glucose and lipids

  3. Rating of symptom severity using the PANSS

  4. Ratings and instrumental measures of motor functioning

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Apr 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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