Official Title: “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 120 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2011

Intervention(s) in this Clinical Trial

• Drug: Nicotine Nasal Spray
  • minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Nicotine Nasal Spray

Primary Measures

• 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.
  • Time Frame: 4 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Medicine and Dentistry New Jersey

Overall Clinical Trial Officials and Contacts

Jill M Williams, MD Principal Investigator University of Medicine and Dentistry New Jersey  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010477

Study ID Number: 1R01DA024640-01A1

ClinicalTrials.gov Identifier: NCT01010477

Health Authority: United States: Institutional Review Board