Smoking Cessation And Reduction in Depression (scarid)

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".

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Smoking in Depressed Patients
• Intervention / Treatment: Device: Ecig 24 mg nicotine; Device: Ecig 0 mg nicotine; Device: Nicotine free inhalator

• Study Type: Interventional
• Enrollment (Anticipated): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sicily
    • Catania, Sicily, Italy, 95100
      • AOU Policlinico - Vittorio Emanuele di Catania
      • Contact: Pasquale Caponnetto; Email: p.caponnetto@unict.it
      • Contact: Giuseppe Minutolo; Email: giuseppeminutolo@hotmail.com
      • Principal Investigator: Eugenio Aguglia, Prof.
      • Principal Investigator: Pasquale Caponnetto, Dr.
      • Principal Investigator: Giuseppe Minutolo, Dr.
      • Principal Investigator: Maria Salvina Signorelli, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking reduction	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").	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuro cognitive functioning and product preferencies	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').	52 weeks

Collaborators and Investigators

• Sponsor: Universita degli Studi di Catania
• Collaborators: Lega Italiana Anti Fumo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 28, 2014

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: SCARID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No