Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Treatments: Ethanol; Nicotine; Varenicline

Criteria

Inclusion Criteria:

• Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment

• Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)

• Current DSM-IV diagnosis of Nicotine Dependence

• Current DSM-IV diagnosis of Alcohol Dependence

• Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)

• An average of at least one pack of cigarettes per day (>=20 cigarettes/day) over the 7 days prior to intake

• An average of at least 7 drinks over the 7 days prior to intake

Exclusion Criteria:

• Inability to give adequate informed consent

• Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.

• Currently taking naltrexone (ReVia), Campral or Antabuse

• Participation in a clinical trial less than 3 months prior to intake

• History of suicide attempt in the past year

• History of hospitalization due to suicidal ideation in the past year

• Suicidal ideation at baseline

• Known allergic reaction to varenicline

• Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control.

• Female patients who are pregnant or nursing.

• Significant unstable medical problems (e.g. impaired renal function).

• Significant unstable psychiatric disorders.

• Subjects who do not attend all required screening appointments.

• Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.

• Positive urine drug screen for cocaine, opioids or amphetamine at baseline

• Current DSM-IV diagnosis of Cocaine, Opioid or Cannabis Dependence (1 month prior to enrollment)

• Metal implants or devices (e.g. aneurysm clips, cochlear implants, neural stimulators, cardiac pacemakers)

• Weight over 250 lbs

• Claustrophobia