Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Phase 2

Completed

Interventions: Behavioral: sensorimotor replacement
Other: usual brand smoking
Drug: 42 mg transdermal nicotine replacement
Drug: Placebo transdermal nicotine

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Active nicotine replacement (NRT) + denicotinized cigarettes	42 mg transdermal nicotine replacement	42 mg nicotine replacement plus sensorimotor replacement
Placebo NRT + denicotinized cigarettes	Placebo transdermal nicotine	inactive transdermal patches plus sensorimotor replacement
Active nicotine replacement (NRT) + denicotinized cigarettes	sensorimotor replacement	42 mg nicotine replacement plus sensorimotor replacement
Placebo NRT + denicotinized cigarettes	sensorimotor replacement	inactive transdermal patches plus sensorimotor replacement
Active NRT + no cigarettes	42 mg transdermal nicotine replacement	42 mg nicotine replacement with no sensorimotor replacement
Placebo NRT + No cigarettes	Placebo transdermal nicotine	Double placebo: No nicotine or sensorimotor replacement
usual brand smoking	usual brand smoking	positive control: usual brand smoking

Primary Outcome Measures

Name	Time	Method
Preferred Brand Smoke Intake (CO)	90 min	preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions

Secondary Outcome Measures

Name	Time	Method
Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)	5 hr	Measure of cigarette craving in which 10 items were rated on 100-mm visual analogue scales (0 = "no urge at all", 100 = "strongest urge you've ever had")