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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Schizophrenia
• Intervention / Treatment: Drug: Nicotine Nasal Spray; Behavioral: Behavioral counseling

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers-Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Nicotrol; Behavioral: Behavioral counseling; Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jill M Williams, MD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 6, 2009
• First Submitted That Met QC Criteria: November 9, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: schizophrenia; smoking cessation; behavioral counseling; nicotine nasal spray
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1R01DA024640-01A1 (U.S. NIH Grant/Contract)