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

Sponsor

Veterans Medical Research Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00167817

Collaborator

(none)

Enrollment

Location

26.1

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2003

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Saliva cotinine, Fagerstrom Test for Nicotine Dependence []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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