Smoking Cessation And Reduction in Depression

Study Overview
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Brief Summary
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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.

Official Title
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Smoking Cessation And Reduction in Depression

Conditions
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Tobacco Smoking in Depressed Patients

Intervention / Treatment
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* Device: Ecig 24 mg nicotine
* Device: Ecig 0 mg nicotine
* Device: Nicotine free inhalator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Major Depressive Disorder (MDD) (according to DSM 5 criteria) from throughout Sicily (Italy), who smoke tobacco cigarettes. smoke ≥10 factory made cig/day, for at least the past five years age 18-65 years in good general health (in absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis ) 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 or other smoking cessation therapies pregnancy or breastfeeding current or recent (less than 1 yr) past history of alcohol and/or drug abuse active suicidal intention 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eCig 24 mg nicotine<br>eCig 24 mg nicotine for 12 weeks | Device: Ecig 24 mg nicotine<br>* eCig 24 mg nicotine for 12 weeks<br>|
| Sham Comparator: Ecig 0 mg nicotine<br>eCig 0 mg nicotine for 12 weeks | Device: Ecig 0 mg nicotine<br>* eCig 0 mg nicotine for 12 weeks<br>|
| Placebo Comparator: Nicotine free inhalator<br>nicotine free inhalator for 12 weeks | Device: Nicotine free inhalator<br>* eCig 24 mg nicotine for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |