Smoking Cessation And Reduction in Depression
Key facts
- Who runs it
- University of Catania
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- Dec 2022
- Ended
- Jun 2024
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ecig 24 mg nicotine
- Ecig 0 mg nicotine
- Nicotine free inhalator
- Record updated
- 14 May 2026
- Why it stopped
- We started with a dedicated protocolol GENESIS RCT
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- use of smokeless tobacco or nicotine replacement therapy or other smoking cessation therapies
- 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 (e.g. cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis
- pregnancy or breastfeeding
- active suicidal intention
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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".
The 3 groups in the trial
- eCig 24 mg nicotineTreatment being tested
eCig 24 mg nicotine for 12 weeks
- Ecig 0 mg nicotineSham treatment, for comparison
eCig 0 mg nicotine for 12 weeks
- Nicotine free inhalatorPlacebo, for comparison
nicotine free inhalator for 12 weeks
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 May 2026