Electronic Cigarettes in Smokers With Mental Illness (APUS e-Cigs)

Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizophreniform Disorder; Bipolar Disorder
• Intervention / Treatment: Other: disposable electronic cigarettes

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AF
    • South London and Maudsley Foundation Trust (SLaM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electronic cigarettes; Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness.

Other: disposable electronic cigarettes; Participants will receive e-cigs free of charge during 6-week. Each week for 6 weeks, participants will receive enough e-cigs to cover 150% of their usual weekly cigarette smoking rate. We will encourage participants to use the e-cigs whenever they would usually smoke a cigarette. During a 4-week post-distribution period, we will assess e-cig and cigarette use and other measures when e-cigs are not being freely provided and participants must purchase them on their own. The Week 10 session at the end of this period includes assessment of total nicotine intake, nicotine dependence, subjective and reinforcing effects of e-cigs and cigarettes, attitudes toward e-cigs, motivation to quit and self-efficacy for smoking cessation. At the Week 24 follow-up session we will again collect these measures to determine if any changes observed during the intervention phases have been maintained.; Other Names: NJOY

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of e-Cigs use	Motivation To Stop Scale -MTSS-	Baseline, week 2, 6, 10 and 24.
Predictors of e-Cigs use	Smoking Consequences Questionnaire	Baseline, week 2, 6, 10 and 24
Psychiatric symptoms	Positive and Negative Syndrome Scale	weekly during the first 10 weeks and at 24 weeks
Psychiatric symptoms	Calgary Depression Scale for Schizophrenia	weekly the first 10 weeks and at 24 weeks
Physical symptoms	Blood pressure and heart rate	weekly the first 10 weeks and at 24 weeks

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Rocio Perez-Iglesias, MD, PhD, King's College London; Principal Investigator: Ann McNeill, BSc, PhD, Prof, King's College London; Principal Investigator: Lynne Dawkins, BSc, PhD, University of East London; Principal Investigator: John Moxham, MD, PhD, Prof, King's College London; Principal Investigator: Philip McGuire, MD, PhD, Prof, King's College London

Publications and helpful links

General Publications

• Hickling LM, Perez-Iglesias R, McNeill A, Dawkins L, Moxham J, Ruffell T, Sendt KV, McGuire P. A pre-post pilot study of electronic cigarettes to reduce smoking in people with severe mental illness. Psychol Med. 2019 Apr;49(6):1033-1040. doi: 10.1017/S0033291718001782. Epub 2018 Jul 10. Erratum In: Psychol Med. 2019 Feb;49(3):528.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2014
• Primary Completion (Actual): May 2, 2017
• Study Completion (Actual): May 2, 2017

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: schizophrenia; smoking; serious mental illness; electronic cigarettes
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: 149240