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

Primary Purpose

Smoking Cessation, Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nicotine Nasal Spray
Behavioral counseling
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring smoking cessation, schizophrenia, nicotine nasal spray, behavioral counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers-Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotine Nasal Spray

Placebo nasal spray

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2009
Last Updated
September 5, 2014
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01010477
Brief Title
Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
Official Title
Double-Blind, Placebo-Controlled Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Schizophrenia
Keywords
smoking cessation, schizophrenia, nicotine nasal spray, behavioral counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine Nasal Spray
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine Nasal Spray
Other Intervention Name(s)
Nicotrol
Intervention Description
minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day
Intervention Type
Behavioral
Intervention Name(s)
Behavioral counseling
Intervention Description
Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.
Primary Outcome Measure Information:
Title
The Number of Subjects Who Quit Smoking From Weeks 5 to 8
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill M Williams, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

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

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