Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Brown University75 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Tobacco Use Disorder Schizophrenia

Interventions

sensorimotor replacementBEHAVIORAL

denicotinized cigarettes

42 mg transdermal nicotine replacementDRUG

2 21-mg nicotine patches

Placebo transdermal nicotineDRUG

2 placebo patches matched to 21-mg nicotine patches

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * schizophrenia or no psychiatric illness * 18 and older * men and women * cigarette smokers, 20-50 cigarettes per day * would like to quit someday Exclusion Criteria: * medical conditions excluding transdermal nicotine replacement * pregnancy or lactation

Locations (1)

Brown University, 121 South Main Street

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Preferred Brand Smoke Intake (CO)

preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions

Time frame: 90 min

Secondary Outcomes

Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)

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")

Time frame: 5 hr

Data from ClinicalTrials.gov

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