Electronic Cigarettes in Smokers With Mental Illness

Not Applicable

Completed

• Conditions: Schizophreniform Disorder; Bipolar Disorder; Schizophrenia
• Interventions: Other: disposable electronic cigarettes

• Registration Number: NCT02212041
• Lead Sponsor: King's College London

Brief Summary

People with mental illness are more likely to smoke and are more severely addicted to nicotine than the general population. As a result, the number of deaths related to tobacco is higher.

Smoking is highly addictive because it delivers nicotine very quickly. Research studies show that people who use nicotine replacement therapies (such us patches, gums, etc) are more likely to quit smoking than those who try to quit without using these nicotine products. Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals contained in tobacco cigarettes.

Given the increasing popularity of e-cigs, there is an urgent need to improve our understanding of both the potential benefits and risks of e-cigs use in people with serious mental illness. In this pilot we propose inviting 50 people with schizophrenia (or schizophrenia-related disorder) who are not intending to quit smoking in the near future to take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week period in which they will not receive free e-cigs and we monitor which products participants choose, and a final 24-week follow-up visit. During the 24-week study period we will assess the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants, nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as well as the e-cigs perceived benefits and risks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Study Start: 2014-09-24
• Status Verified: 2015-08
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• smokers (≥ 5 cigarettes/day for > 1 yr and breath CO > 5 ppm)
• ages 18-65 years
• ICD-10 diagnosis of schizophreniform, schizophrenia, schizoaffective or bipolar disorder

Exclusion Criteria

• used e-cigs on > 2 occasions in the past 30 days;
• intend to quit smoking within the next 30 days;
• currently use medications that may reduce smoking (bupropion, varenicline, NRT, naltrexone, buprenorphine, acamprosate, baclofen, clonidine, nortriptyline, anti-seizure medications, disulfiram);
• have unstable psychiatric conditions (hospitalization or change in dose of chronic medication in the past 30 days);
• People with a serious medical condition including uncontrolled high blood pressure, something wrong with their heart or blood vessels that occurred or got worse in the past 3 months (including fast or irregular heart rhythm, angina, chest pain, had a heart attack or stroke).
• People who have ever had a serious stomach ulcer, and/or phaeochromocytoma (tumor of the adrenal gland).
• People who in the last 3 months have had severe heartburn; or a stroke, or unstable kidney disease, unstable liver disease, uncontrolled over-active thyroid gland
• met DSM-IV criteria for drug dependence
• have medical contraindications to nicotine, since nicotine intake may increase in this study;
• have past-month suicidal ideation or past-year suicide attempt.
• are pregnant, as determined through a pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic cigarettes	disposable electronic cigarettes	Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness.

Primary Outcome Measures

Name	Time	Method
Electronic cigarette use	weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks	Time Line Follow Back (TLFB) questionnaire
electronic cigarette acceptability	Baseline, week 2, week6, week 10 and week 24	electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)
Respiratory symptoms	weekly the first 10 weeks and at 24 weeks	Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.
Cotinine	Baseline, week 2, 6, 10 and 24	Cotinine levels in urine
Nitrosamines	Baseline and at 6 week	NNAL and 3-HPMA levels in urine
Side effects of antipsychotics	weekly the first 10 weeks and at 24 weeks	The Udvalg for Kliniske Undersøgelser (UKU) scale
Withdrawal symptoms	weekly the first 10 weeks and at 24 weeks	Mood and Physical Symptoms Scale, MPSS

Secondary Outcome Measures

Name	Time	Method
Predictors of e-Cigs use	Baseline, week 2, 6, 10 and 24	Smoking Consequences Questionnaire
Psychiatric symptoms	weekly the first 10 weeks and at 24 weeks	Calgary Depression Scale for Schizophrenia
Physical symptoms	weekly the first 10 weeks and at 24 weeks	Blood pressure and heart rate

Trial Locations

Locations (1)

South London and Maudsley Foundation Trust (SLaM); 🇬🇧 London, United Kingdom