Smoking Cessation And Reduction in Depression (scarid)

• ClinicalTrials.gov Identifier: NCT02124187
• Recruitment Status: Not yet recruiting
• First Posted: April 28, 2014
• Last Update Posted: May 17, 2022
• Sponsor: Universita degli Studi di Catania
• Collaborator: Lega Italiana Anti Fumo
• Information provided by (Responsible Party): Riccardo Polosa, Universita degli Studi di Catania

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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').

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

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.

• 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
• Last Update Posted: May 17, 2022
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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