Clinical trial NCT04001114: Cigarette Smoking in Smokers With and Without Schizophrenia
Official title: Cigarette Smoking in Smokers With and Without a Diagnosis of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Schizophrenia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will compare participants with and without a diagnosis of schizophrenia. Study procedures are identical for the two groups.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: End-of-session Carbon Monoxide
timeFrame: One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.
measure: Cigarette Discrimination Accuracy
timeFrame: One day (in the Cigarette Discrimination Session), over a 6-hour time frame.
Secondary outcomes:
measure: Change in the Number of Research Cigarettes Smoked
timeFrame: One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.
measure: Difference in Subjective State Composite Score
timeFrame: One day (in the Cigarette Discrimination Session), over a 6-hour time frame.
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Britta Hahn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: