NCT01979796

Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning.

Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning: Design of a Randomized Trial. Smoking Cessation And Reduction In Schizophrenia (The SCARIS Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Universita degli Studi di Catania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are no large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.

Detailed description

The investigators 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 schizophrenic smokers not intending to quit. The investigators will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).

Conditions

• Tobacco Smoking in Schizophrenic Patients

Interventions

Type	Name	Description
DEVICE	Ecig 24 mg nicotine	Cigalike
DEVICE	Ecig 0 mg nicotine	Cigalike
DEVICE	Nicotine free inhalator	Plastic CIG a Like

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2013-11-08
• Last updated: 2022-05-17