Smoking Cessation And Reduction in Depression

NCT02124187 | Unknown DMC

• 1 other identifier: SCARID
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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".

Conditions

Tobacco Smoking in Depressed Patients

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation

  Abstinence from smoking, defined as complete self-reported abstinence from tobacco smoking - not even a puff (together with an eCO concentration of ≤7 ppm), will be calculated at each study visit ("quitters").

  52 weeks

Secondary Outcomes (1)

• Smoking reduction

  52 weeks

Other Outcomes (1)

• Neuro cognitive functioning and product preferencies

  52 weeks

Study Arms (3)

eCig 24 mg nicotine

EXPERIMENTAL

eCig 24 mg nicotine for 12 weeks

Device: Ecig 24 mg nicotine

Ecig 0 mg nicotine

SHAM COMPARATOR

eCig 0 mg nicotine for 12 weeks

Device: Ecig 0 mg nicotine

Nicotine free inhalator

PLACEBO COMPARATOR

nicotine free inhalator for 12 weeks

Device: Nicotine free inhalator

Interventions

Ecig 24 mg nicotine DEVICE

eCig 24 mg nicotine for 12 weeks

eCig 24 mg nicotine

Ecig 0 mg nicotine DEVICE

eCig 0 mg nicotine for 12 weeks

Ecig 0 mg nicotine

Nicotine free inhalator DEVICE

eCig 24 mg nicotine for 12 weeks

Nicotine free inhalator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• use of smokeless tobacco or nicotine replacement therapy or other smoking cessation therapies
• pregnancy or breastfeeding
• current or recent (less than 1 yr) past history of alcohol and/or drug abuse
• 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

Sponsors & Collaborators

• Universita degli Studi di Catania: lead
• Lega Italiana Anti Fumo: collaborator

Study Sites (1)

AOU Policlinico - Vittorio Emanuele di Catania

Catania, Sicily, 95100, Italy

Location

Related Publications (1)

• 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.

  PMID: 24655473 BACKGROUND

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of internal medicine

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

IT (1)