- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04001114
Cigarette Smoking in Smokers With and Without Schizophrenia
October 7, 2022 updated by: Britta Hahn, University of Maryland, Baltimore
Cigarette Smoking in Smokers With and Without a Diagnosis of Schizophrenia
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Britta Hahn, Ph.D.
- Phone Number: 4104026112
- Email: bhahn@som.umaryland.edu
Study Locations
-
-
Maryland
-
Catonsville, Maryland, United States, 21228
- Recruiting
- Maryland Psychiatric Research Center
-
Contact:
- Britta Hahn, Ph.D.
- Email: bhahn@som.umaryland.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Smokers with schizophrenia
This is a diagnostic group, defined independently from this study.
|
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.
|
Other: Smokers without schizophrenia
This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in exhaled 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 beginning of the Ad Libitum Smoking Session (baseline), and at the end eight hours later.
The change value is obtained by subtracting each participant's baseline value from the end-of-session value.
|
One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.
|
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.
|
One day (in the Cigarette Discrimination Session), over a 6-hour time frame.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number of research cigarettes smoked
Time Frame: One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.
|
In the Ad Libitum Smoking Session, participants can smoke as many research cigarettes as they wish.
We quantify the number of cigarettes smoked in the first two hours and in the last two hours of the session and calculate the difference score by subtracting the number in the last two hours from that in the first two hours.
|
One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.
|
Difference in subjective state composite score
Time Frame: One day (in the Cigarette Discrimination Session), over a 6-hour time frame.
|
The difference in subjective state composite score is derived by transforming each subject's score on the Minnesota Nicotine Withdrawal Scale, the Affect-based Withdrawal Scale, the Questionnaire for Smoking Urges, and the modified Cigarette Evaluation Questionnaire into standard z-scores, calculating the difference between Research Cigarette A and B for each scale, and averaging the absolute values across scales.
|
One day (in the Cigarette Discrimination Session), over a 6-hour time frame.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Britta Hahn, Ph.D., University of Maryland School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2021
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
June 24, 2019
First Submitted That Met QC Criteria
June 26, 2019
First Posted (Actual)
June 27, 2019
Study Record Updates
Last Update Posted (Actual)
October 10, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00086422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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