Skip to main content
OpenTrials
Completed

NCT Number: NCT01214005

Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls

This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. The second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year and older

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

In this study, smokers with schizophrenia and smokers without psychiatric illness participate in a nicotine preference task before and after a 3-day period of continuous smoking abstinence. The investigators will experimentally control abstinence by providing participants with high-value cash incentives contingent upon smoking abstinence verified with breath carbon monoxide levels. The investigators will measure nicotine withdrawal and smoking urge during the abstinence period. In the nicotine preference task, participants will make choices between nicotine-containing and denicotinized cigarette puffs to provide a measure of nicotine reinforcement, and the investigators will also measure the effects of smoking on mood. After the second nicotine preference task, participants will receive a small-value reinforcer if they continue to abstain for another day, and the investigators will measure time to the second lapse.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • cigarette smokers, 20-50 cigarettes per day
  • schizophrenia or no psychiatric illness
  • age 18 or older
  • male or female

Exclusion criteria

  • unstable symptoms or medication
  • not interested in quitting smoking within 6 months

Treatment and study plan

smoking abstinence

Behavioral

3 days of biologically-confirmed smoking abstinence

Primary outcomes

  1. Withdrawal symptoms

    Time frame: 3 days

    negative mood related to nicotine withdrawal

  2. urge to smoke

    Time frame: 3 days

    craving for smoking

  3. nicotine preference

    Time frame: before and after 3 days of abstinence

    choice for nicotine puffs versus denicotinized cigarette puffs

  4. positive and negative mood

    Time frame: before and after 3 days of abstinence

    positive and negative mood scale

Secondary outcomes

  1. time to lapse

    Time frame: 192 hours

    time between smoking behavior in the laboratory and first cigarette outside of the laboratory

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Acronym: WREN

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2010
Registry last updated
Apr 27, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.