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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smokers with schizophrenia | Other | This is a diagnostic group, defined independently from this study. |
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| Smokers without schizophrenia | Other | This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sampling Research Cigarettes | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| End-of-session Carbon Monoxide | 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. | One day (in the Ad Libitum Smoking Session), over an 8-hour time frame. |
| Cigarette Discrimination Accuracy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Research Cigarettes Smoked | In the Ad Libitum Smoking Session, participants can smoke as many research cigarettes (all very-low-nicotine-content) as they wish. The propensity to maintain smoking despite the absence of nicotine was quantified by subtracting the number of cigarettes smoked in the last two hours from that in the first two hours of the session. Smaller difference values indicate that smoking was upheld by very-low-nicotine-content cigarettes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britta Hahn, Ph.D. | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Psychiatric Research Center | Catonsville | Maryland | 21228 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Smokers With Schizophrenia | This is a diagnostic group, defined independently from this study. 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. |
| FG001 | Smokers Without Schizophrenia | This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smokers With Schizophrenia | This is a diagnostic group, defined independently from this study. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | End-of-session Carbon Monoxide | 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. | One smoker with schizophrenia and one smoker without schizophrenia did not complete the study session in which this measurement was obtained but completed all other study sessions. | Posted | Mean | Standard Deviation | parts per million (ppm) | One day (in the Ad Libitum Smoking Session), over an 8-hour time frame. |
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There were three study days, plus the screening session, for a total of 4 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smokers With Schizophrenia | This is a diagnostic group, defined independently from this study. 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. |
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The targeted enrollment was not achieved, and sample sizes are smaller than necessary to assess all study predictions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Britta Hahn, Ph.D. | University of Maryland | 410-402-6112 | bhahn@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | May 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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We will compare participants with and without a diagnosis of schizophrenia. Study procedures are identical for the two groups.
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Participants compare different research cigarettes. Neither the participant nor the investigators know which cigarette is of which type.
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| One day (in the Ad Libitum Smoking Session), over an 8-hour time frame. |
| Difference in Subjective State Composite Score | The measure is derived by transforming scores on the Minnesota Nicotine Withdrawal Scale (where higher values signify more withdrawal), the Affect-based Withdrawal Scale (higher values signify a worse emotional state), Questionnaire for Smoking Urges (higher values indicate more craving), and modified Cigarette Evaluation Questionnaire (mCEQ, higher values indicate greater subjective effects of smoking on mood, hunger, physiology) into standard z-scores, thus giving each scale a mean of 0 and standard deviation of 1. Withdrawal and craving scores were re-poled (inversing the sign), and scales were averaged for each subject. The resulting composite quantified the subjective state response to cigarette smoking, larger values indicating less withdrawal, less craving, and larger effects on the mCEQ. The difference therein between the research cigarettes containing nicotine and those containing almost no nicotine quantified the subjective state response to nicotine. | One day (in the Cigarette Discrimination Session), over a 6-hour time frame. |
| BG001 | Smokers Without Schizophrenia | This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Smokers Without Schizophrenia | This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study. 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. |
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| Primary | Cigarette Discrimination Accuracy | 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 smoker with schizophrenia did not complete the study session in which this measurement was obtained, but completed the rest of the study. | Posted | Mean | Standard Deviation | percentage of choices that were correct | One day (in the Cigarette Discrimination Session), over a 6-hour time frame. |
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| Secondary | Change in the Number of Research Cigarettes Smoked | In the Ad Libitum Smoking Session, participants can smoke as many research cigarettes (all very-low-nicotine-content) as they wish. The propensity to maintain smoking despite the absence of nicotine was quantified by subtracting the number of cigarettes smoked in the last two hours from that in the first two hours of the session. Smaller difference values indicate that smoking was upheld by very-low-nicotine-content cigarettes. | One smoker with schizophrenia and one smoker without schizophrenia did not complete the study session in which this measurement was obtained but completed the rest of the study. | Posted | Mean | Standard Deviation | difference in cigarettes smoked | One day (in the Ad Libitum Smoking Session), over an 8-hour time frame. |
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| Secondary | Difference in Subjective State Composite Score | The measure is derived by transforming scores on the Minnesota Nicotine Withdrawal Scale (where higher values signify more withdrawal), the Affect-based Withdrawal Scale (higher values signify a worse emotional state), Questionnaire for Smoking Urges (higher values indicate more craving), and modified Cigarette Evaluation Questionnaire (mCEQ, higher values indicate greater subjective effects of smoking on mood, hunger, physiology) into standard z-scores, thus giving each scale a mean of 0 and standard deviation of 1. Withdrawal and craving scores were re-poled (inversing the sign), and scales were averaged for each subject. The resulting composite quantified the subjective state response to cigarette smoking, larger values indicating less withdrawal, less craving, and larger effects on the mCEQ. The difference therein between the research cigarettes containing nicotine and those containing almost no nicotine quantified the subjective state response to nicotine. | One smoker with schizophrenia and one smoker without schizophrenia did not complete the study session in which this measurement was obtained. One additional smoker with schizophrenia did not complete the subjective state measurements but completed all other aspects of the session. | Posted | Mean | Standard Deviation | difference in z-score | One day (in the Cigarette Discrimination Session), over a 6-hour time frame. |
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| EG001 | Smokers Without Schizophrenia | This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study. 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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