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

Veterans Medical Research Foundation

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00167817

030762

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)