Clinical trial NCT02124187: Smoking Cessation And Reduction in Depression
Official title: Smoking Cessation And Reduction in Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Smoking in Depressed Patients
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
Collaborators: name: Lega Italiana Anti Fumo
First posted: 2014-04-28
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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".


Eligibility criteria: 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

Primary outcomes:
measure: Smoking Cessation
timeFrame: 52 weeks
Secondary outcomes:
measure: Smoking reduction
timeFrame: 52 weeks
Other outcomes:
measure: Neuro cognitive functioning and product preferencies
timeFrame: 52 weeks
Locations:
city: Catania
country: Italy
facility: AOU Policlinico - Vittorio Emanuele di Catania
state: Sicily
Study officials:
References:
citation: 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.