Tobacco Smoking in Schizophrenic Patients Clinical Trial
— SCARISOfficial title:
Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning: Design of a Randomized Trial. Smoking Cessation And Reduction In Schizophrenia (The SCARIS Study)
| Verified date | May 2022 |
| Source | Universita degli Studi di Catania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are no large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.
| Status | Not yet recruiting |
| Enrollment | 153 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Schizophrenic subjects (according to DSM-IV-TR criteria) from throughout Sicily, (Italy), who smoke tobacco cigarettes, in stable phase of illness. - smoke =10 factory made cig/day, for at least the past five years - age 18-65 years - in good general health - not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months - committed to follow the trial procedures. Exclusion Criteria: - use of smokeless tobacco or nicotine replacement therapy - pregnancy or breastfeeding. - current or recent (less than 1 yr) past history of alcohol and/or drug abuse - other significant co-morbidities according to the Investigator's clinical assessment |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Universita degli Studi di Catania |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Evaluation of neurocognitive functioning | Quality of life, Neurocognitive Functioning and Psychopathological status will be assessed at each study visit by Quality of Life Scale (QLS), Brief Assessment of Cognition in Schizophrenia (BACS) and Positive and Negative Symptoms Scale(PANSS), respectively Participants' perception and liking of the product will be assessed by asking to rate their level of satisfaction with the products compared to their own cigarettes using a visual analogue scale (VAS) from 0 to 10 points (0 = being 'completely unsatisfied', 10 being = 'fully satisfied'); using the same scale, they will also rate how much they miss their own brand (0 = being 'did not miss it at all', 10 being = 'missed too much') and whether they would recommend it to a friend/relative (0 = being 'not recommended at all', 10 being = 'absolutely recommended'). |
52 weeks | |
| Primary | smoking cessation | Abstinence from smoking, defined as complete self-reported abstinence from tobacco smoking - not even a puff (together with an eCO concentration of =7 ppm), will be calculated at each study visit ("quitters"). | 52 weeks | |
| Secondary | Smoking reduction | A =50% reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (=50%) compared to baseline (together with an eCO levels reduction, to objectively document a reduction from baseline), will be calculated at each study visit ("reducers"). Smokers who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders". |
52 weeks |