Status:
COMPLETED
A Study of Varenicline for Prevention of Relapse to Smoking in Patients With Schizophrenia or Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA for treatment of nicotine dependence and may be particularly beneficial in smokers with schizophrenia or bip...
Detailed Description
Participants will be moderate to heavy smokers, aged 18-70, who have smoked an average of ≥10 cigarettes/day for the past year and who have not quit during the past year for a period \>1 month. Durin...
Eligibility Criteria
Inclusion
- Women and men aged 18-70
- DSM-IV diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder by diagnostic interview and chart review
- Smoke at least 10 cigarettes per day
- Clinically stable, on a stable dose of antipsychotic (schizophrenia) or mood stabilizer (bipolar) medication for at least 1 month
- No current active suicidal ideation
- Expired air carbon monoxide (CO) concentration \>9 ppm
- Willing to take study medications and set a quit date within 2-3 weeks of beginning treatment and be willing to participate in the relapse prevention and follow-up portions of the study
- Women of childbearing potential must have a negative urine pregnancy test at baseline and agree to use an approved form of contraception during the study.
Exclusion
- DSM-IV diagnosis of dementia, neurodegenerative disease, or other organic mental disorder
- Substance use disorder other than nicotine or caffeine in the last 6 months
- Major depressive disorder within the last 6 months
- Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 2 months
- Life-threatening arrhythmia or cerebro-vascular event within 6 months, cardiovascular event within 2 months or uncontrolled hypertension
- History of multiple head injuries with neurological sequelae, a single severe head injury with lasting neurological sequelae, or current CNS tumor
- Liver function tests elevated over twice normal
- Renal insufficiency with estimated creatinine clearance \<40 ml/min
- Plan to continue use of tobacco products othe than cigarettes (e.g., cigar, pipe)
- Use of an investigational medication or device in the past 30 days
- Current suicidal or homicidal ideation
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00621777
Start Date
February 1 2008
End Date
May 1 2013
Last Update
December 21 2017
Active Locations (10)
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1
University of Alabama Psychology Clinic
Birmingham, Alabama, United States, 35233
2
Centerstone Research Institute
Bloomington, Indiana, United States, 47401
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Massachusetts Mental Health Center
Boston, Massachusetts, United States, 02115