NCT02124187

Smoking Cessation And Reduction in Depression

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Universita degli Studi di Catania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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".

Conditions

• Tobacco Smoking in Depressed Patients

Interventions

Type	Name	Description
DEVICE	Ecig 24 mg nicotine	eCig 24 mg nicotine for 12 weeks
DEVICE	Ecig 0 mg nicotine	eCig 0 mg nicotine for 12 weeks
DEVICE	Nicotine free inhalator	eCig 24 mg nicotine for 12 weeks

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2014-04-28
• Last updated: 2022-05-17

Locations

1 site across 1 country: Italy