A three-month Electronic Nicotine Delivery System (ENDS)-based intervention in a homeless context: efficacy, challenges and opportunities
| ISRCTN | ISRCTN14767579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14767579 |
| Secondary identifying numbers | ENDSHOMELESS |
- Submission date
- 19/10/2019
- Registration date
- 05/11/2019
- Last edited
- 16/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Waterford Institute of Technology
Cork Road
Waterford
0
Ireland
 ORCID ID |
0000-0001-9585-5068 |
|---|---|
| Phone | +353851122345 |
| florian.scheibein@postgrad.wit.ie |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A 3-month Electronic Nicotine Delivery System (ENDS)-based intervention in a homeless context: efficacy, challenges and opportunities |
| Study acronym | ENDSHOMELESS |
| Study objectives | 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(s) | Approved 05/11/2018, Waterford Institute of Technology Ethics Committee (Cork Road Campus, Waterford, Co.Waterford, Ireland; +353 51302609; skiely@wit.ie), ref: WIT2018REC0005 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 27/03/2018 |
| Completion date | 04/06/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 23 |
| Key inclusion criteria | 1. >5 COppm 2. Active smoking status 3. Expressed intention to quit using ENDS-device |
| Key exclusion criteria | 1. Active pregnancy status 2. Exhibition of acute florid mental health or substance use-related issues |
| Date of first enrolment | 01/02/2019 |
| Date of final enrolment | 11/03/2019 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
000
Ireland
Sponsor information
University/education
Health Science Building
Rossa Avenue
Waterford
-
Ireland
| Phone | +353 (0)51302774 |
|---|---|
| agalloway@wit.ie | |
| Website | https://www.wit.ie/schools/health_sciences/school-of-health-sciences |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Intention to publish in Harm Reduction Journal. Intention to write follow up articles and to promote |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/10/2020 | 16/10/2020 | Yes | No |
Editorial Notes
16/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
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.
