Tobacco Smoking in Depressed Patients Clinical Trial
— scaridOfficial title:
Smoking Cessation And Reduction in Depression
| NCT number | NCT02124187 |
| Other study ID # | SCARID |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2022 |
| Est. completion date | June 2024 |
| 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 depressed patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".
| Status | Not yet recruiting |
| Enrollment | 129 |
| Est. completion date | June 2024 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: 1. Patients with Major Depressive Disorder (MDD) (according to DSM 5 criteria) from throughout Sicily (Italy), who smoke tobacco cigarettes. 2. smoke =10 factory made cig/day, for at least the past five years 3. age 18-65 years 4. in good general health (in absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis ) 5. 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 6. committed to follow the trial procedures. Exclusion Criteria: 1. use of smokeless tobacco or nicotine replacement therapy or other smoking cessation therapies 2. pregnancy or breastfeeding 3. current or recent (less than 1 yr) past history of alcohol and/or drug abuse 4. active suicidal intention 5. other significant co-morbidities according to the Investigator's clinical assessment (e.g. cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis |
| Country | Name | City | State |
|---|---|---|---|
| Italy | AOU Policlinico - Vittorio Emanuele di Catania | Catania | Sicily |
| Lead Sponsor | Collaborator |
|---|---|
| Universita degli Studi di Catania | Lega Italiana Anti Fumo |
Italy,
Caponnetto P, Polosa R, Auditore R, Minutolo G, Signorelli M, Maglia M, Alamo A, Palermo F, Aguglia E. Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial. Trials. 2014 Mar 22;15:88. doi: 10.1186/1745-6215-15-88. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Neuro cognitive functioning and product preferencies | Quality of life, Neurocognitive Functioning and Psychopathological status will be reassessed by Quality of Life Scale (QLS), Repeatable Battery for the assessment of Neuropsychological Study (RBANS) and Hamilton Depression Rating Scale (HDRS), 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"). | 52 weeks |