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

NCT01010477 | Completed Phase 4 Results DMC

• 1 other identifier: 1R01DA024640-01A1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Schizophrenia

Keywords

smoking cessation; schizophrenia; nicotine nasal spray; behavioral counseling

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nicotine Nasal Spray

EXPERIMENTAL

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; Behavioral: Behavioral counseling

Placebo nasal spray

PLACEBO COMPARATOR

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; Behavioral: Behavioral counseling

Interventions

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

Also known as: Nicotrol

Nicotine Nasal Spray; Placebo nasal spray

Behavioral counseling BEHAVIORAL

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

Nicotine Nasal Spray; Placebo nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Schizophrenia

Interventions

Tobacco Use Cessation Devices; Nicotine; Behavior Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Jill Williams, MD, Principal Investigator
• Organization: Rutgers-Robert Wood Johnson Medical School

Jill.williams@rutgers.edu

7322354341

Study Officials

• Jill M Williams, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 10, 2009
• Study Start: August 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 8, 2014
• Results First Posted: September 8, 2014

Record last verified: 2014-09

Locations

US (1)