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Completed

NCT Number: NCT01213524

Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

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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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University, 121 South Main Street

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sensorimotor replacement

Behavioral

denicotinized cigarettes

42 mg transdermal nicotine replacement

Drug

2 21-mg nicotine patches

Placebo transdermal nicotine

Drug

2 placebo patches matched to 21-mg nicotine patches

usual brand smoking

Other

participant smokes usual brand of cigarette

Primary outcomes

  1. Preferred Brand Smoke Intake (CO)

    Time frame: 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 outcomes

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

    Time frame: 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")

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Biological and Behavioral Mechanisms of Smoking in Schizophrenia

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2010
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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