Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Condition: Cigarette Smoking; Schizophrenia
MeSH terms: Schizophrenia
Intervention: varenicline; placebo
Intervention description: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.; At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this proposed pilot study is to examine the use of varenicline in people with
      schizophrenia to specifically assess tolerability and efficacy for smoking cessation.
      Specifically, The primary objective of this pilot study is to determine if taking of
      varenicline along with an individual smoking cessation supportive program is a safe and
      effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the
      varenicline treated patients will achieve higher rates of smoking cessation than those who
      receive placebo and individual support.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-64

          -  Regular ten cigarette per day smoker for one year

          -  Nicotine Dependency Score greater than or equal to four

          -  DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder

          -  Psychiatric medication regimen unchanged for at least 90 days

          -  Psychiatric medication dosage unchanged for at least 30 days

        Exclusion Criteria:

          -  Psychiatric hospitalization in last 6 months

          -  Meets criteria for current Major Depressive Disorder or has a score of greater than 10
             on the Calgary Depression Scale (see withdrawal criteria)

          -  Suicide or homicide ideation with a plan in the last six months

          -  Life time history of suicide attempt

          -  Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three
             years

          -  Current treatment with Bupropion SR

          -  DSM-IV diagnosis of alcohol or substance dependence within last 6 months*

          -  DSM-IV diagnosis of alcohol or substance abuse within three months *

          -  Pregnancy or lactation in females (+HCG)

          -  Use of tobacco product other than cigarettes

          -  Use of nicotine replacements

          -  Unstable or serious medical condition in last 6 months

          -  Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not
             apply to abuse of or dependence on nicotine.