Varenicline and Smoking Cessation in Schizophrenia
Condition: Schizophrenia; Smoking Cessation
MeSH terms: Schizophrenia
Intervention: Sugar Pill; Varenicline; Bupropion HCl
Intervention description: Sugar pill created and masked by the pharmacy to be used as a control.; Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.; in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
Intervention MeSH terms: Bupropion; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Schizophrenia; Smoking cessation; Varenicline; Bupropion

Summary:

      There is a strong association between smoking and schizophrenia with prevalence rates ranging
      from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number
      of hypotheses have been proposed to explain the relationship between high smoking rates and
      schizophrenia, mostly relating to self-medication primarily for the negative symptoms of
      schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower
      than for other psychiatric disorders. The negative health effects of smoking increase the
      morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl
      in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not
      been any published studies of the efficacy of varenicline in schizophrenic subjects. As
      varenicline appears to be a promising treatment in non-psychiatric patients, it would be
      useful to expand these studies to examine its effects in schizophrenic patients. Identifying
      effective and safe means of smoking cessation for this vulnerable population has the
      potential to reduce morbidity and mortality among individuals with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, 18-75 years old

          -  Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and
             Statistical Manual of Mental Disorders IV (DSM-IV) criteria

          -  Smoking at least 10 cigarettes per day

          -  Weight of at least 100 lbs (45.4 kg)

          -  Motivation to quit smoking

          -  Stabilized psychotic symptoms

          -  Provision of informed consent for testing and treatment

        Exclusion Criteria:

          -  Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder

          -  Seizure disorder, recent withdrawal from alcohol or anxiolytics

          -  History of bulimia nervosa, anorexia nervosa, or dementia

          -  History of depression, panic, or bipolar disorders

          -  Pregnancy or lactation

          -  Prior use of varenicline or bupropion HCl within three months prior to initiation of
             the study

          -  Current use of other smoking cessation treatments

          -  Regular use of non-cigarette tobacco products (> than once/week)

          -  Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6
             months

          -  Patients with suicidal ideations or plans

          -  Florid psychosis or increasing psychosis following varenicline or bupropion HCl
             treatment

          -  History of, or current, alcohol dependence/abuse

          -  Current use of monoamine oxidase inhibitors (MAOI)