NCT00167817

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole

Timeline

• Start date: 2003-07-01
• Completion: 2005-09-01
• First posted: 2005-09-14
• Last updated: 2007-04-19

Locations

1 site across 1 country: United States