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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01010477
First received: November 6, 2009
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Schizophrenia
Drug: Nicotine Nasal Spray
Behavioral: Behavioral counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • The Number of Subjects Who Quit Smoking From Weeks 5 to 8 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
Study Start Date: August 2009
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine Nasal Spray
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
minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day
Other Name: Nicotrol
Behavioral: Behavioral counseling
Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.
Placebo Comparator: Placebo nasal spray
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
minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day
Other Name: Nicotrol
Behavioral: Behavioral counseling
Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010477

Locations
United States, New Jersey
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Jill M Williams, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01010477     History of Changes
Other Study ID Numbers: 1R01DA024640-01A1, 1R01DA024640-01A1
Study First Received: November 6, 2009
Results First Received: March 6, 2014
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
smoking cessation
schizophrenia
nicotine nasal spray
behavioral counseling

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014