Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biological and Behavioral Mechanisms of Smoking in Schizophrenia

Conditions
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Tobacco Use Disorder, Schizophrenia

Intervention / Treatment
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* Behavioral: sensorimotor replacement
* Drug: 42 mg transdermal nicotine replacement
* Drug: Placebo transdermal nicotine
* Other: usual brand smoking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Within-subjects design study that investigated 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). Participants were smokers with schizophrenia and equally-heavy smokers without psychiatric disorders. Each participant underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, usual-brand cigarettes + no patches.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active nicotine replacement (NRT) + denicotinized cigarettes<br>42 mg nicotine replacement plus sensorimotor replacement | Behavioral: sensorimotor replacement<br>* denicotinized cigarettes<br>Drug: 42 mg transdermal nicotine replacement<br>* 2 21-mg nicotine patches<br>|
| Active Comparator: Placebo NRT + denicotinized cigarettes<br>inactive transdermal patches plus sensorimotor replacement | Behavioral: sensorimotor replacement<br>* denicotinized cigarettes<br>Drug: Placebo transdermal nicotine<br>* 2 placebo patches matched to 21-mg nicotine patches<br>|
| Active Comparator: Active NRT + no cigarettes<br>42 mg nicotine replacement with no sensorimotor replacement | Drug: 42 mg transdermal nicotine replacement<br>* 2 21-mg nicotine patches<br>|
| Placebo Comparator: Placebo NRT + No cigarettes<br>Double placebo: No nicotine or sensorimotor replacement | Drug: Placebo transdermal nicotine<br>* 2 placebo patches matched to 21-mg nicotine patches<br>|
| Active Comparator: usual brand smoking<br>positive control: usual brand smoking | Other: usual brand smoking<br>* participant smokes usual brand of cigarette<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 5 hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine, craving, dual-diagnosis, comorbidity