Cigarette Smoking in Smokers With and Without Schizophrenia

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Tobacco Dependence; Schizophrenia

Treatments: Combination Product: Sampling Research Cigarettes

Study type: Interventional

Funder types: Other

Identifiers

NCT04001114

HP-00086422

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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
• For healthy control smokers: immediate family history of psychosis

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Smokers with schizophrenia

Other group

Description:

This is a diagnostic group, defined independently from this study.

Treatment:

Combination Product: Sampling Research Cigarettes

Smokers without schizophrenia

Other group

Description:

This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study.

Treatment:

Combination Product: Sampling Research Cigarettes