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Smoking Cessation And Reduction in Depression (scarid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02124187
Recruitment Status : Not yet recruiting
First Posted : April 28, 2014
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
Lega Italiana Anti Fumo
Information provided by (Responsible Party):
Riccardo Polosa, Universita degli Studi di Catania

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".


Condition or disease Intervention/treatment Phase
Tobacco Smoking in Depressed Patients Device: Ecig 24 mg nicotine Device: Ecig 0 mg nicotine Device: Nicotine free inhalator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation And Reduction in Depression
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eCig 24 mg nicotine
eCig 24 mg nicotine for 12 weeks
Device: Ecig 24 mg nicotine
eCig 24 mg nicotine for 12 weeks

Sham Comparator: Ecig 0 mg nicotine
eCig 0 mg nicotine for 12 weeks
Device: Ecig 0 mg nicotine
eCig 0 mg nicotine for 12 weeks

Placebo Comparator: Nicotine free inhalator
nicotine free inhalator for 12 weeks
Device: Nicotine free inhalator
eCig 24 mg nicotine for 12 weeks




Primary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 52 weeks ]
    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").


Secondary Outcome Measures :
  1. Smoking reduction [ Time Frame: 52 weeks ]
    A ≥50% reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥50%) compared to baseline (together with an eCO levels reduction, to objectively document a reduction from baseline), will be calculated at each study visit ("reducers").


Other Outcome Measures:
  1. Neuro cognitive functioning and product preferencies [ Time Frame: 52 weeks ]

    Quality of life, Neurocognitive Functioning and Psychopathological status will be reassessed by Quality of Life Scale (QLS), Repeatable Battery for the assessment of Neuropsychological Study (RBANS) and Hamilton Depression Rating Scale (HDRS), respectively.

    Participants' perception and liking of the product will be assessed by asking to rate their level of satisfaction with the products compared to their own cigarettes using a visual analogue scale (VAS) from 0 to 10 points (0 = being 'completely unsatisfied', 10 being = 'fully satisfied'); using the same scale, they will also rate how much they miss their own brand (0 = being 'did not miss it at all', 10 being = 'missed too much') and whether they would recommend it to a friend/relative (0 = being 'not recommended at all', 10 being = 'absolutely recommended').




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124187


Locations
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Italy
AOU Policlinico - Vittorio Emanuele di Catania
Catania, Sicily, Italy, 95100
Contact: Pasquale Caponnetto       p.caponnetto@unict.it   
Contact: Giuseppe Minutolo       giuseppeminutolo@hotmail.com   
Principal Investigator: Eugenio Aguglia, Prof.         
Principal Investigator: Pasquale Caponnetto, Dr.         
Principal Investigator: Giuseppe Minutolo, Dr.         
Principal Investigator: Maria Salvina Signorelli, Dr.         
Sponsors and Collaborators
Universita degli Studi di Catania
Lega Italiana Anti Fumo
Publications:
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Responsible Party: Riccardo Polosa, Full Professor of internal medicine, Universita degli Studi di Catania
ClinicalTrials.gov Identifier: NCT02124187    
Other Study ID Numbers: SCARID
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action