Conditions: Tobacco Use Disorder Schizophrenia
Keywords: nicotine craving dual-diagnosis comorbidity
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 75
Healthy volunteers: yes

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.

Arms:
arm 1: 42 mg nicotine replacement plus sensorimotor replacement arm 2: inactive transdermal patches plus sensorimotor replacement arm 3: 42 mg nicotine replacement with no sensorimotor replacement arm 4: Double placebo: No nicotine or sensorimotor replacement arm 5: positive control: usual brand smoking

Interventions: intervention 1: sensorimotor replacement intervention 2: 42 mg transdermal nicotine replacement intervention 3: Placebo transdermal nicotine intervention 4: usual brand smoking
Intervention descriptions: intervention 1: denicotinized cigarettes intervention 2: 2 21-mg nicotine patches intervention 3: 2 placebo patches matched to 21-mg nicotine patches intervention 4: participant smokes usual brand of cigarette

Protocol document: