Tobacco DependenceNCT04001114
Cigarette Smoking in Smokers With and Without Schizophrenia
A study testing Sampling Research Cigarettes in people with Tobacco Dependence and Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, Schizophrenia
- What is being tested?
- Sampling Research Cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
Official title: 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.
Read the 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
- Being tested
- Sampling Research Cigarettes
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling Research CigarettesCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Smokers with schizophrenia | Other | This is a diagnostic group, defined independently from this study. Receives: Combination Product: Sampling Research Cigarettes |
| Smokers without schizophrenia | Other | This is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study. Receives: Combination Product: Sampling Research Cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One day (in the Cigarette Discrimination Session), over a 6-hour time frame.
Secondary outcomes (2)
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.
Measured: 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.
Measured: One day (in the Cigarette Discrimination Session), over a 6-hour time frame.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start15 Jul 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will compare participants with and without a diagnosis of schizophrenia. Study procedures are identical for the two groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britta Hahn, University of Maryland, Baltimore
- Investigators
- Britta Hahn, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001114
- Sponsor's protocol ID
- HP-00086422
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2019
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cigarette Smoking in Smokers With and Without a Diagnosis of Schizophrenia
- ClinicalTrials.gov ID
- NCT04001114
- Acronym / sponsor ID
- HP-00086422
- Conditions
- Tobacco Dependence, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Posted 26 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- We will compare participants with and without a diagnosis of schizophrenia. Study procedures are identical for the two groups.
| Arm | Type | Receives |
|---|---|---|
| Smokers with schizophrenia | Other | Combination Product: Sampling Research CigarettesThis is a diagnostic group, defined independently from this study. |
| Smokers without schizophrenia | Other | Combination Product: Sampling Research CigarettesThis is a diagnostic group (i.e., no diagnosis of schizophrenia), defined independently from this study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling Research CigarettesParticipants 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. | Combination product | Smokers with schizophrenia, Smokers without schizophrenia |
Primary outcome
End-of-session 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 end of the 8-hour Ad Libitum Smoking Session. Only very-low-nicotine-content (virtually nicotine-free) cigarettes were consumed in this session.
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.
2 secondary outcomes
Change in the Number of Research Cigarettes Smoked
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britta Hahn, Ph.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling Research Cigarettes in people with Tobacco Dependence and Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-of-session Carbon Monoxide (time frame: One day (in the Ad Libitum Smoking Session), over an 8-hour time frame.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.