Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

In this study, we will compare cue-reactivity in smokers with and without schizophrenia and the influence of smoking cues on responding for cigarette puffs under a PR schedule of reinforcement. Given the high prevalence of smoking among individuals with schizophrenia, understanding some of the environmental factors that serve to maintain nicotine dependence is a critical step in improving smoking cessation treatment outcomes. Establishing and validating a laboratory model of cue-elicited responsivity and cigarette self- administration will allow the investigation of the efficacy of anti-craving medications in people with schizophrenia.

Specific Aims 1) To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia. 2) To compare the effects of smoking versus neutral cues on the reinforcing efficacy of tobacco cigarettes in smokers with schizophrenia and smokers without schizophrenia.

Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).

The ratio of 3-HC/cotinine is a phenotypic biomarker of the rate of nicotine metabolism, which has been shown to be associated with level of nicotine dependence, various smoking behaviors, and treatment outcome (Ho & Tyndale, 2007). We will correlate the primary measures with the 3-HC/cotinine ratio to explore possible relationships for future study.

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Key information

Conditions

Schizophrenia Behavior Chemically-Induced Disorders Mental Disorders Nicotine Dependence Schizophrenia Spectrum and Other Psychotic Disorders Smoking Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

Catonsville, Maryland, 21228, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion Criteria for Schizophrenia Patients

18-64 year old males and females
Smoking at least 10 cigarettes per day for at least 1 year
Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
Current DSM-IV diagnosis of schizophrenia and stable medication regimen (see above)
Medically healthy as determined by screening criteria
Inclusion Criteria for Healthy Volunteers

18-64 year old males and females
Smoking at least 10 cigarettes per day for at least 1 year
Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
Medically and psychologically healthy as determined by screening criteria
Exclusion Criteria for Schizophrenia Patients

Current interest in reducing or quitting tobacco use
Treatment for tobacco dependence in the past 3 months
Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
Consumption of more than 15 alcoholic drinks per week during the past month
Use of any illicit drug more than twice per week during the past month
Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, first-generation antipsychotics, and mood stabilizers)
Under the influence of a drug or alcohol at experimental sessions
Pregnant, nursing, or become pregnant during the study
Exclusion Criteria for Healthy Volunteers

Current interest in reducing or quitting tobacco use
Treatment for tobacco dependence in the past 3 months
Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
Consumption of more than 15 alcoholic drinks per week during the past month
Use of any illicit drug more than twice per week during the past month
Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, antipsychotics, and mood stabilizers)
Under the influence of a drug or alcohol at experimental sessions
Pregnant, nursing, or become pregnant during the study

Treatment and study plan

Smoking Cues

Behavioral

In the smoking cue condition, a pack of the participants preferred brand of cigarettes, a lighter, and an ashtray will be under the tray cover. In the neutral cue condition, a pack of unsharpened pencils, a pencil sharpener, and a small notepad will be under the cover. When instructed, the participant will lift the cover on the tray. In the smoking cue condition, participants will take one cigarette out of the pack, light it without puffing, hold it for 1 minute, extinguish the cigarette, and replace the cover on the tray.

Neutral Cues

Behavioral

In the neutral cue condition, participants will take one pencil out of the pack, sharpen it, hold it for 1 minute as if to write on the notepad, and then replace the cover. Participants will complete the VAS during cue exposure and the TCQ-SF, VAS, and mood form immediately and 15 minutes after cue presentation; physiological measures will be recorded continuously.

Primary outcomes

To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.

Time frame: 7-10 Days

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Oct 9, 2008
Registry last updated: Aug 19, 2019

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.

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

Completed