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Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

NCT ID: NCT01213524

Last Updated: 2020-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2011-03-31

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.

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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.

Conditions

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Tobacco Use Disorder Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and outcomes assessor were blind to patch condition (NIC or PLA)

Study Groups

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Active nicotine replacement (NRT) + denicotinized cigarettes

42 mg nicotine replacement plus sensorimotor replacement

Group Type ACTIVE_COMPARATOR

sensorimotor replacement

Intervention Type BEHAVIORAL

denicotinized cigarettes

42 mg transdermal nicotine replacement

Intervention Type DRUG

2 21-mg nicotine patches

Placebo NRT + denicotinized cigarettes

inactive transdermal patches plus sensorimotor replacement

Group Type ACTIVE_COMPARATOR

sensorimotor replacement

Intervention Type BEHAVIORAL

denicotinized cigarettes

Placebo transdermal nicotine

Intervention Type DRUG

2 placebo patches matched to 21-mg nicotine patches

Active NRT + no cigarettes

42 mg nicotine replacement with no sensorimotor replacement

Group Type ACTIVE_COMPARATOR

42 mg transdermal nicotine replacement

Intervention Type DRUG

2 21-mg nicotine patches

Placebo NRT + No cigarettes

Double placebo: No nicotine or sensorimotor replacement

Group Type PLACEBO_COMPARATOR

Placebo transdermal nicotine

Intervention Type DRUG

2 placebo patches matched to 21-mg nicotine patches

usual brand smoking

positive control: usual brand smoking

Group Type ACTIVE_COMPARATOR

usual brand smoking

Intervention Type OTHER

participant smokes usual brand of cigarette

Interventions

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sensorimotor replacement

denicotinized cigarettes

Intervention Type BEHAVIORAL

42 mg transdermal nicotine replacement

2 21-mg nicotine patches

Intervention Type DRUG

Placebo transdermal nicotine

2 placebo patches matched to 21-mg nicotine patches

Intervention Type DRUG

usual brand smoking

participant smokes usual brand of cigarette

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Tidey

Associate Professor (Research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Tidey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Brown University, 121 South Main Street

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA014002

Identifier Type: NIH

Identifier Source: org_study_id

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