Cigarette Smoking in Smokers With and Without Schizophrenia

NCT ID: NCT04001114

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-12-23

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.

Conditions

Tobacco Dependence; Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Smokers with schizophrenia

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

Group Type: OTHER

Sampling Research Cigarettes

Intervention Type: COMBINATION_PRODUCT

Participants sample two research cigarettes, which differ in typical tobacco smoke constituents such as tar, nicotine, carbon monoxide, etc. In the Cigarette Discrimination Session, participants sample both types of cigarettes repeatedly, guess their identity (A or B) with regard to reference cigarettes, and rate their subjective effects. In the Ad Libitum Smoking Session, participants can smoke one of these cigarette types as much or as little as they like for eight hours.

Smokers without schizophrenia

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

Group Type: OTHER

Sampling Research Cigarettes

Intervention Type: COMBINATION_PRODUCT

Participants sample two research cigarettes, which differ in typical tobacco smoke constituents such as tar, nicotine, carbon monoxide, etc. In the Cigarette Discrimination Session, participants sample both types of cigarettes repeatedly, guess their identity (A or B) with regard to reference cigarettes, and rate their subjective effects. In the Ad Libitum Smoking Session, participants can smoke one of these cigarette types as much or as little as they like for eight hours.

Interventions

Sampling Research Cigarettes

Participants sample two research cigarettes, which differ in typical tobacco smoke constituents such as tar, nicotine, carbon monoxide, etc. In the Cigarette Discrimination Session, participants sample both types of cigarettes repeatedly, guess their identity (A or B) with regard to reference cigarettes, and rate their subjective effects. In the Ad Libitum Smoking Session, participants can smoke one of these cigarette types as much or as little as they like for eight hours.

Intervention Type: COMBINATION_PRODUCT

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
• For healthy control smokers: immediate family history of psychosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Britta Hahn

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Britta Hahn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00086422

Identifier Type: -

Identifier Source: org_study_id