Condition category
Not Applicable
Date applied
19/10/2019
Date assigned
05/11/2019
Last edited
11/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Smoking is highly prevalent amongst populations accessing homeless services and these populations may be disproportionately affected by tobacco-related harm. This study aims to investigate the efficacy, challenges and opportunities of conducting an Electronic Nicotine Delivery System (ENDS)-based intervention with a population accessing homeless services

Who can participate?
Smokers who intend to quit, who attend a Supported Temporary Accommodation (STA) homeless service in Dublin

What does the study involve?
Each study participant was supplied with an Endura T22e Electronic Nicotine Delivery System and two 10ml bottles of fluid which was available in following strengths (0, 6, 11, 18 and 20mg/ml) and flavours ('Purple Berry', 'Ice Menthol', 'Regular Blend' and 'American Tobacco'). Measurements related to tobacco use and dependence were taken every four weeks for three months.

What are the possible benefits and risks of participating?
The study aims to help participants quit or reduce tobacco smoking. This is the primary benefit of participating. Study participants will receive an Endura T22e™ device and weekly allotments of fluid during the study period. Participation in all components of the study will be compensated with 15 euro One4All™ vouchers at Weeks 1, 4, 8 and 12.
Short term harms may include sore throat, headaches, nausea or cracked lips. Long terms have not been clearly established. Participants are strongly encouraged to cease using the devices at the end of the study due to the unknown nature of long term harms.

Where is the study run from?
Dublin Simon Community, Ireland

When is the study starting and how long is it expected to run for?
February 2019 to June 2019

Who is funding the study?
Knowledge Action Change

Who is the main contact?
Florian Scheibein
fscheibein@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Florian Scheibein

ORCID ID

https://orcid.org/0000-0001-9585-5068

Contact details

Waterford Institute of Technology
Cork Road
Waterford
0
Ireland
+353851122345
florian.scheibein@postgrad.wit.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ENDSHOMELESS

Study information

Scientific title

A 3-month Electronic Nicotine Delivery System (ENDS)-based intervention in a homeless context: efficacy, challenges and opportunities

Acronym

ENDSHOMELESS

Study hypothesis

Smoking is highly prevalent amongst populations accessing homeless services and these populations may be disproportionately affected by tobacco-related harm. This study aims to investigate the efficacy, challenges and opportunities of conducting an Electronic Nicotine Delivery System (ENDS)-based intervention with a population accessing homeless services

Ethics approval

Approved 05/11/2018, Waterford Institute of Technology Ethics Committee (Cork Road Campus, Waterford, Co.Waterford, Ireland; +353 51302609; skiely@wit.ie), ref: WIT2018REC0005

Study design

Interventional non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Smoking of tobacco products.

Intervention

Study participants were recruited from a Supported Temporary Accomodation (STA) homeless service.

Baseline measures for self-reported number of cigarettes smoked, Fagerstrom score, Mood and Physical Symptom Scale and COppm were obtained. Participants were supplied with an Endura T22e Electronic Nicotine Delivery System and two 10ml bottles of fluid, participants could choose nicotine-containing fluid out of 4 flavours ('Ice Menthol', 'Purple Berry', 'Regular Blend' and 'American Tobacco') and five strengths (0, 6, 11, 18 and 20 mg/ml) which were dispensed in weekly allotments upon CO measurements. Fagerstrom Test, Mood and Physical Symptom Scale and daily cigarette consumption were recorded again at weeks 4, 8 and 12

Study participants were compensated with a 15 euro 'One4All' voucher at Week 1. The primary researcher attended the service on a weekly basis. Study participants could obtain additional fluid (maximum 2 bottles per week) and support. CO concentration was recorded at weeks 4, 8, and 12, any positive or negative experiences reported were recorded. Study participants were compensated with additional 15 euro vouchers for participating in these sessions. Participation in sessions at Week 1, 4, 8 and 12 were considered mandatory for the definition of study completion. An exit interview was completed at the end of the study

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

At weeks 1, 4, 8 and 12:
1. Self-reported number of cigarettes smoked daily
2. Total COppm using a carbon monoxide breath analyzer
3. Nicotine Dependence measured by Fagerstrom score
4. Mood and Physical Symptom Scale

Secondary outcome measures

Qualitative reports obtained during interviews (any comments that study participants have regarding the efficacy of the device and issues and/or side effects they had)

Overall trial start date

27/03/2018

Overall trial end date

04/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. >5 COppm
2. Active smoking status
3. Expressed intention to quit using ENDS-device

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Active pregnancy status
2. Exhibition of acute florid mental health or substance use-related issues

Recruitment start date

01/02/2019

Recruitment end date

11/03/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Dublin Simon Community
Assorted
Dublin
000
Ireland

Sponsor information

Organisation

Waterford Institute of Technology

Sponsor details

Health Science Building
Rossa Avenue
Waterford
-
Ireland
+353 (0)51302774
agalloway@wit.ie

Sponsor type

University/education

Website

https://www.wit.ie/schools/health_sciences/school-of-health-sciences

Funders

Funder type

Research organisation

Funder name

Knowledge Action Change

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish in Harm Reduction Journal. Intention to write follow up articles and to promote

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/01/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2019: The following changes were made to the trial record: 1. The exclusion criteria were added. 2. The secondary outcome measures were updated. 07/11/2019: Internal review. 04/11/2019: Trial’s existence confirmed by Waterford Institute of Technology Ethics Committee.