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Clinical Trials/NCT04001114
NCT04001114
Recruiting
Not Applicable

Cigarette Smoking in Smokers With and Without a Diagnosis of Schizophrenia

University of Maryland, Baltimore1 site in 1 country90 target enrollmentJuly 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Dependence
Sponsor
University of Maryland, Baltimore
Enrollment
90
Locations
1
Primary Endpoint
End-of-session Carbon Monoxide
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Higher rates and severity of tobacco dependence in people with schizophrenia, as compared with the general population, contribute to the lower life expectancy seen in this population. Dependent tobacco smoking is controlled by how different aspects of cigarette smoking are perceived. There is evidence suggesting that people with schizophrenia differ in how they perceive cigarette smoking, which, if confirmed, would have implications for tailoring treatment interventions for smoking cessation in schizophrenia.

Detailed Description

The aim of the present study is to determine whether tobacco smoking in people with schizophrenia is governed by different aspects and effects of cigarette consumption. Smokers participating in this study either have no psychiatric diagnosis, or a diagnosis of schizophrenia or schizoaffective disorder. Over four study visits, participants will sample and compare different research cigarettes, complete questionnaires and concentration tasks, and smoke one type of research cigarette for eight hours while wearing a nicotine patch. By shaping our understanding of tobacco dependence in schizophrenia, the present project may redirect treatment development toward strategies tailored to the specific vulnerabilities of this population, which is among the most severely affected by its detrimental impact on health and life.

Registry
clinicaltrials.gov
Start Date
July 15, 2021
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Britta Hahn

Associate Professor

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • Regular smoker of at least 10 cigarettes or cigarillos/day for at least 2 years
  • For participants with schizophrenia: DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • For participants with schizophrenia: Able to give informed consent
  • For smokers with schizophrenia: No change in psychiatric medication or dosage in the last 4 weeks

Exclusion Criteria

  • Uncontrolled hypertension (resting systolic BP above 150 or diastolic above 95 mm Hg)
  • Cardiovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, severe arrhythmias, or EKG abnormalities
  • Severe asthma
  • Chronic obstructive pulmonary disease
  • Neurological illness, such as stroke, seizure disorder, neurodegenerative disease, or organic brain syndrome
  • Mental retardation
  • Alcohol or substance use disorder except nicotine within the last year
  • Use of benztropine (Cogentin), varenicline (Chantix), bupropion (Wellbutrin, Zyban), or any type of nicotine replacement
  • Pregnant or lactating
  • For healthy control smokers: DSM-5 diagnosis of depression, bipolar disorder, ADHD, autism spectrum disorder, anorexia, bulimia nervosa, or any schizophrenia-spectrum disorder

Outcomes

Primary Outcomes

End-of-session Carbon Monoxide

Time Frame: One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.

The concentration (ppm) of carbon monoxide (CO) in breath is measured by exhalation into a CO breathalyzer at the end of the 8-hour Ad Libitum Smoking Session. Only very-low-nicotine-content (virtually nicotine-free) cigarettes were consumed in this session.

Cigarette Discrimination Accuracy

Time Frame: One day (in the Cigarette Discrimination Session), over a 6-hour time frame.

Participants sample 4 cigarettes of type A and 4 cigarettes of type B in a double-blind manner and indicate for each cigarette if they think it is of type A or B. Two reference trials with cigarette type unblinded will be performed before the first and fifth sample cigarette. For each sampled cigarette, the score is either 1 (correct) or 0 (incorrect). Discrimination accuracy is calculated by averaging the eight scores for each participant.

Secondary Outcomes

  • Change in the Number of Research Cigarettes Smoked(One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.)
  • Difference in Subjective State Composite Score(One day (in the Cigarette Discrimination Session), over a 6-hour time frame.)

Study Sites (1)

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