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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Tobacco Smoking in Schizophrenic Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ecig 24 mg nicotine

Group Type EXPERIMENTAL

Ecig 24 mg nicotine

Intervention Type DEVICE

Cigalike

Ecig 0 mg nicotine

Group Type SHAM_COMPARATOR

Ecig 0 mg nicotine

Intervention Type DEVICE

Cigalike

Nicotine free inhalator

Group Type PLACEBO_COMPARATOR

Nicotine free inhalator

Intervention Type DEVICE

Plastic CIG a Like

Interventions

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Ecig 24 mg nicotine

Cigalike

Intervention Type DEVICE

Ecig 0 mg nicotine

Cigalike

Intervention Type DEVICE

Nicotine free inhalator

Plastic CIG a Like

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No