NCT01010477

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2009-11-10
• Last updated: 2014-09-08
• Results posted: 2014-09-08

Locations

1 site across 1 country: United States