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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jonathan M Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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VA San Diego Healthcare System

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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030762

Identifier Type: -

Identifier Source: org_study_id