NCT02124187.

Study name	Smoking cessation and reduction in depression (SCARID)
Methods	3‐arm prospective 12‐m randomized controlled trial investigating efficacy and safety of ECs
Participants	129 participants Inclusion criteria: Diagnosis of major depressive disorder (MDD) (according to DSM‐5 criteria) Smoke ≥ 10 cpd (for at least the past 5 years) age 18 ‐ 65 years In good general health Unwilling to quit smoking in the next 30 days Exclusion criteria: Use of smokeless tobacco or NRT or other smoking cessation therapies ​ Pregnancy or breastfeeding ​ Current or recent (< 1 yr) past history of alcohol or drug abuse or both ​ 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)
Interventions	12‐wk supply of: EC 24 mg nicotine EC 0 mg nicotine Nicotine‐free inhalator
Outcomes	Follow‐up visits at 4, 8, 12, 24 and 52 weeks Outcome measures: Smoking cessation Smoking reduction (≥ 50% from baseline) Adverse events Quality of life Neurocognitive functioning Participant perceptions and satisfaction with products
Starting date	February 2015
Contact information	Pasquale Caponnetto p.caponnetto@unict.it
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