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

NCT01979796 | Unknown DMC

• 1 other identifier: SCARIS
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tobacco Smoking in Schizophrenic Patients

Keywords

Addiction, Schizophrenia, Electronic cigarettes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Smoking reduction

  52 weeks

Other Outcomes (1)

• Evaluation of neurocognitive functioning

  52 weeks

Study Arms (3)

Ecig 24 mg nicotine

EXPERIMENTAL

Ecig 24 mg nicotine

Device: Ecig 24 mg nicotine

Ecig 0 mg nicotine

SHAM COMPARATOR

Ecig 0 mg nicotine

Device: Ecig 0 mg nicotine

Nicotine free inhalator

PLACEBO COMPARATOR

Nicotine free inhalator

Device: Nicotine free inhalator

Interventions

Ecig 24 mg nicotine DEVICE

Cigalike

Ecig 24 mg nicotine

Ecig 0 mg nicotine DEVICE

Cigalike

Ecig 0 mg nicotine

Nicotine free inhalator DEVICE

Plastic CIG a Like

Nicotine free inhalator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita degli Studi di Catania: lead

Related Publications (1)

• 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.

  PMID: 24655473 DERIVED

MeSH Terms

Conditions

Behavior, Addictive; Schizophrenia; Vaping

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Smoking

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Pasquale Caponnetto, Assis Prof

  University of Catania

  PRINCIPAL INVESTIGATOR

• Eugenio Aguglia, Professor

  University of Catania

  PRINCIPAL INVESTIGATOR

• Giuseppe Minutolo, Assis prof

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 8, 2013
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-05