Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
Condition: Smoking Cessation; Schizophrenia
MeSH terms: Schizophrenia
Intervention: Nicotine Nasal Spray; Behavioral counseling
Intervention description: minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day; Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking cessation; schizophrenia; nicotine nasal spray; behavioral counseling

Summary:

      This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine
      nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The
      objectives of this study are to determine the efficacy of NNS with behavioral intervention
      for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of
      subjects who receive NNS and behavioral intervention will be significantly greater than the
      quit rate of the control group who will receive the placebo spray plus same behavioral
      intervention. Quit rate is defined as the proportion of individuals who self report no
      tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10
      parts per million during these 4 weeks. The investigators will also assess abstinence rates
      at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been
      stopped. Since studies of this group suggest high relapse rates when treatments are
      discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the
      investigators will continue NNS treatment for a total of 20 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be invited to participate in the study if they fulfill the following
             inclusion criteria:

               1. Meet DSM-IV diagnostic criteria for Schizophrenia

               2. Be 18 years of age or older

               3. Be daily smokers of 10 or more cigarettes per day (cpd)

               4. Have an expired CO level > 9 ppm

               5. Be motivated to quit smoking

               6. Be willing to adhere to the study protocol (e.g. provide samples, attend all
                  visits)

               7. Be able to give informed consent

               8. Stable on their current atypical antipsychotic medication for at least one month.

        Exclusion Criteria:

          -  Subjects will be excluded based on any one of the following exclusion criteria:

               1. Current suicidal risk, including active suicidal ideation, recent suicidal
                  behavior or suicide attempt in the past 30 days,

               2. Psychiatric hospitalization in the last 30 days

               3. Inability to read or understand the questionnaires in English

               4. Current pregnancy or lactation or plans to become pregnant in the next 12 months

               5. Regular use of non-cigarette forms of tobacco including cigars, pipes, smokeless
                  tobacco

               6. Patients with significant cognitive impairment that may interfere with their
                  study participation assessed as a Folstein Mini-Mental Status exam score of less
                  than 22.