N/A
N=31
Cigarette Smoking in Smokers With and Without Schizophrenia
Tobacco Dependence · Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT04001114 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: End-of-session Carbon Monoxide — 62.7; 43.0 parts per million (ppm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sampling Research Cigarettes (Combination_product)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY End-of-session Carbon Monoxide |
62.7; 43.0 | — |
| PRIMARY Cigarette Discrimination Accuracy |
65.6; 81.9 | — |
| SECONDARY Change in the Number of Research Cigarettes Smoked |
1.75; 1.50 | — |
| SECONDARY Difference in Subjective State Composite Score |
0.13; 0.039 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04001114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.