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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00167817

Enrollment

Registered

2005-09-14

Start date

2003-07-31

Completion date

2005-09-30

Last updated

2007-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Smoking, Metabolic, Health, Glucose, Lipids

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.

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.

Interventions

DRUGAripiprazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Saliva cotinine, Fagerstrom Test for Nicotine Dependence	—

Secondary

Measure	Time frame
Weight	—
Serum glucose and lipids	—
Rating of symptom severity using the PANSS	—
Ratings and instrumental measures of motor functioning	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026