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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010477
• Other study ID #: 1R01DA024640-01A1
• Secondary ID: 1R01DA024640-01A
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2009
• Last updated: September 5, 2014
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Smoking Cessation

Intervention

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

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

Locations

Country	Name	City	State
United States	Rutgers-Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No