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Completed

NCT Number: NCT01010477

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine Nasal Spray

Drug

minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day

Other names: Nicotrol

Behavioral Counseling

Behavioral

Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.

Primary outcomes

  1. The Number of Subjects Who Quit Smoking From Weeks 5 to 8

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2009
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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