Electronic Cigarettes in Smokers With Mental Illness

Schizophrenia Clinical Trial

— APUS e-Cigs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212041
• Other study ID #: 149240
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: May 15, 2017
• Start date: September 24, 2014
• Est. completion date: May 2, 2017

Study information

• Verified date: August 2015
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophreniform Disorder

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley Foundation Trust (SLaM)	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electronic cigarette use	Time Line Follow Back (TLFB) questionnaire	weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks
Primary	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
Primary	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
Primary	Cotinine	Cotinine levels in urine	Baseline, week 2, 6, 10 and 24
Primary	Nitrosamines	NNAL and 3-HPMA levels in urine	Baseline and at 6 week
Primary	Side effects of antipsychotics	The Udvalg for Kliniske Undersøgelser (UKU) scale	weekly the first 10 weeks and at 24 weeks
Primary	Withdrawal symptoms	Mood and Physical Symptoms Scale, MPSS	weekly the first 10 weeks and at 24 weeks
Primary	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	Predictors of e-Cigs use	Motivation To Stop Scale -MTSS-	Baseline, week 2, 6, 10 and 24.
Secondary	Predictors of e-Cigs use	Smoking Consequences Questionnaire	Baseline, week 2, 6, 10 and 24
Secondary	Psychiatric symptoms	Positive and Negative Syndrome Scale	weekly during the first 10 weeks and at 24 weeks
Secondary	Psychiatric symptoms	Calgary Depression Scale for Schizophrenia	weekly the first 10 weeks and at 24 weeks
Secondary	Physical symptoms	Blood pressure and heart rate	weekly the first 10 weeks and at 24 weeks