Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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Double-Blind, Placebo-Controlled Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia

Conditions
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Smoking Cessation, Schizophrenia

Intervention / Treatment
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* Drug: Nicotine Nasal Spray
* Behavioral: Behavioral counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be invited to participate in the study if they fulfill the following inclusion criteria: Meet DSM-IV diagnostic criteria for Schizophrenia Be 18 years of age or older Be daily smokers of 10 or more cigarettes per day (cpd) Have an expired CO level > 9 ppm Be motivated to quit smoking Be willing to adhere to the study protocol (e.g. provide samples, attend all visits) Be able to give informed consent 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: Current suicidal risk, including active suicidal ideation, recent suicidal behavior or suicide attempt in the past 30 days, Psychiatric hospitalization in the last 30 days Inability to read or understand the questionnaires in English Current pregnancy or lactation or plans to become pregnant in the next 12 months Regular use of non-cigarette forms of tobacco including cigars, pipes, smokeless tobacco 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Nasal Spray<br>Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. . Nasal spray will be used from the TQD through the end of Week 20. | Drug: Nicotine Nasal Spray<br>* minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day<br>* Other names: Nicotrol;Behavioral: Behavioral counseling<br>* Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.<br>|
| Placebo Comparator: Placebo nasal spray<br>Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Nasal spray will be used from the TQD through the end of Week 20. | Drug: Nicotine Nasal Spray<br>* minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day<br>* Other names: Nicotrol;Behavioral: Behavioral counseling<br>* Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects Who Quit Smoking From Weeks 5 to 8 | 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 (ppm) during these 4 weeks. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, schizophrenia, nicotine nasal spray, behavioral counseling