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



Status:Recruiting
Conditions:Schizophrenia, Smoking Cessation
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:August 2009
Contact:Mia H Zimmermann, MPH, CTTS
Email:hanosma@umdnj.edu
Phone:732-235-4879

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


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.


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.
We found this trial at
1
site
Camden, New Jersey 08103
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from
Camden, NJ
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