Status:
COMPLETED
Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
Brief 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 m...
Detailed Description
Alcohol use (more than 33%) and smoking (80-90%) commonly occur together in patients with schizophrenia. Varenicline (ChantixTM) has been approved by the FDA as a medication for smoking cessation. Rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00727103
Start Date
July 1 2008
End Date
May 1 2011
Last Update
February 8 2024
Active Locations (1)
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1
SUNY Upstate Medical University
Syracuse, New York, United States, 13210