Varenicline and Smoking Cessation in Schizophrenia
Condition: Schizophrenia; Smoking Cessation
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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. The smoking cessation agent bupropion HCl
      has been tested in schizophrenics, but the results on its efficacy are inconclusive. Recent
      works by different laboratories have shown the safety and efficacy of varenicline, a partial
      alpha4beta2 and full alpha7 nicotinic acetylcholine receptor agonist, as a smoking cessation
      agent. However, to date, no published studies have tested the safety and efficacy of
      varenicline in treatment of nicotine dependence in schizophrenic patients. As varenicline
      appears to be a promising treatment in non-psychiatric patients, it would be beneficial to
      examine its effects in schizophrenic patients. The central hypothesis of this application is
      that treatment with varenicline will safely increase smoking abstinence rates in
      schizophrenic patients when compared to those receiving placebo. This central hypothesis will
      be tested and the objectives of this application accomplished by pursuing two Specific Aims:
      1) Treatment with varenicline or bupropion HCl for a period of three months will increase
      smoking abstinence rates in schizophrenic patents when compared to placebo; and 2) Treatment
      with varenicline or bupropion HCl for a period of three months will not increase psychosis in
      schizophrenic patients when compared to placebo. For our General Investigational Plan, we
      will employ a double-blind randomized placebo controlled study to assess varenicline's safety
      and efficacy. It is our expectation that we will demonstrate that varenicline is safe and
      effective in decreasing smoking rates in schizophrenic patients without exacerbating
      psychotic symptoms. Such outcomes will be significant, because they will offer a new
      treatment for smoking cessation in this vulnerable population.
    

Intervention name(s): Sugar Pill; Varenicline; Bupropion HCl
Intervention type(s): Other; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Chantix; Wellbutrin; Zyban
Intervention MeSH terms: Bupropion; Varenicline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Smoking cessation; Varenicline; Bupropion