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Smoking Cessation And Reduction in Depression

NCT02124187 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-05-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lega Italiana Anti Fumo

    collaborator OTHER

  • Universita degli Studi di Catania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02124187 on ClinicalTrials.gov