Electronic Cigarettes in Smokers With Mental Illness

NCT02212041 | Completed

• 1 other identifier: 149240
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizophreniform Disorder; Bipolar Disorder

Keywords

electronic cigarettes; smoking; schizophrenia; serious mental illness

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Predictors of e-Cigs use

  Baseline, week 2, 6, 10 and 24.

• Predictors of e-Cigs use

  Baseline, week 2, 6, 10 and 24

• Psychiatric symptoms

  weekly during the first 10 weeks and at 24 weeks

• Psychiatric symptoms

  weekly the first 10 weeks and at 24 weeks

• Physical symptoms

  weekly the first 10 weeks and at 24 weeks

Study Arms (1)

Electronic cigarettes

EXPERIMENTAL

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

Other: disposable electronic cigarettes

Interventions

disposable electronic cigarettes OTHER

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.

Also known as: NJOY

Electronic cigarettes

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

South London and Maudsley Foundation Trust (SLaM)

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29986786 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Vaping; Smoking

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: September 24, 2014
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: May 16, 2017

Record last verified: 2015-08

Locations

GB (1)