APUS e-Cigs: Electronic Cigarettes in Smokers With Mental Illness

Sponsor

King's College London (Other)

Overall Status

Completed

CT.gov ID

NCT02212041

Collaborator

(none)

Enrollment

Location

Arm

31.2

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophreniform Disorder Bipolar Disorder	Other: disposable electronic cigarettes	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 24, 2014

Actual Primary Completion Date :

May 2, 2017

Actual Study Completion Date :

May 2, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 measures from baseline to 10 weeks and at 24 weeks]
An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms.
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
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.

Secondary Outcome Measures

Predictors of e-Cigs use [Baseline, week 2, 6, 10 and 24.]
Motivation To Stop Scale -MTSS-
Predictors of e-Cigs use [Baseline, week 2, 6, 10 and 24]
Smoking Consequences Questionnaire
Psychiatric symptoms [weekly during the first 10 weeks and at 24 weeks]
Positive and Negative Syndrome Scale
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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