NCT01213524

Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Biological and Behavioral Mechanisms of Smoking in Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with schizophrenia and non-psychiatric smokers.

Detailed description

This study used a mixed between- and within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content \[VLNC\] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine \[NIC\] vs. placebo \[PLA\] patches) in smokers with schizophrenia and control smokers without psychiatric illness. Each session contained a 5-h controlled administration period in which participants underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, Usual Brand cigarettes + no patches. Next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance followed by a 90-min period of ad libitum usual-brand smoking.

Conditions

• Tobacco Use Disorder
• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	sensorimotor replacement	denicotinized cigarettes
DRUG	42 mg transdermal nicotine replacement	2 21-mg nicotine patches
DRUG	Placebo transdermal nicotine	2 placebo patches matched to 21-mg nicotine patches
OTHER	usual brand smoking	participant smokes usual brand of cigarette

Timeline

• Start date: 2005-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-10-04
• Last updated: 2020-10-19
• Results posted: 2020-09-09

Locations

1 site across 1 country: United States