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

Universita degli Studi di Catania

Status: Not yet enrolling

Conditions: Tobacco Smoking in Schizophrenic Patients

Treatments: Device: Ecig 24 mg nicotine; Device: Nicotine free inhalator; Device: Ecig 0 mg nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT01979796

SCARIS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 153 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Schizophrenic subjects (according to DSM-IV-TR criteria) from throughout Sicily, (Italy), who smoke tobacco cigarettes, in stable phase of illness.
• smoke ≥10 factory made cig/day, for at least the past five years
• age 18-65 years
• in good general health
• 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.

Exclusion criteria

• use of smokeless tobacco or nicotine replacement therapy
• pregnancy or breastfeeding.
• current or recent (less than 1 yr) past history of alcohol and/or drug abuse
• other significant co-morbidities according to the Investigator's clinical assessment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 3 patient groups, including a placebo group

Ecig 24 mg nicotine

Experimental group

Description:

Ecig 24 mg nicotine

Treatment:

Device: Ecig 24 mg nicotine

Ecig 0 mg nicotine

Sham Comparator group

Description:

Ecig 0 mg nicotine

Treatment:

Device: Ecig 0 mg nicotine

Nicotine free inhalator

Placebo Comparator group

Description:

Nicotine free inhalator

Treatment:

Device: Nicotine free inhalator