Plain English Summary
Background and study aims
Homosexual men smoke more often than heterosexual men do. Gay men prefer smoking cessation classes that are specifically designed for gay men. In this study, we want to test whether a smoking cessation programme for gay men helps them quit smoking. The programme is similar to a British programme.
Who can participate?
Smoking gay men or men who have sex with men, older than 18 years and with strong intentions to quit can participate in the study.
What does the study involve?
In the programme, gay men attend one session per week for seven weeks. The participants set a quit day, form "quit teams" and perform regular breathing tests. They learn about nicotine replacement therapy and how to deal with cravings. The facilitators of the programme are gay men. Six months after the programme, the participants are asked whether they have smoked during the past week. Furthermore, they tell us about their use of other drugs, their depression and anxiety levels and their physical health.
What are the possible benefits and risks of participating?
The benefit of this programme is that the participants may be able to give up smoking. There are no risks associated with this programme.
Where is the study run from?
The programme takes place at Checkpoint, a gay health care centre in Zurich, Switzerland.
When is the study starting and how long is it expected to run for?
The study ran between January 2009 and December 2010.
Who is funding the study?
The study is funded by the Swiss Tobacco Control Fund, Switzerland.
Who is the main contact?
Dr Maria Dickson-Spillmann
maria.dickson@isgf.uzh.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Maria Dickson-Spillmann
ORCID ID
Contact details
Swiss Research Institute for Public Health and Addiction ISGF
Konradstrasse 32
Postfach
Zürich
8031
Switzerland
-
maria.dickson@isgf.uzh.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Queer Quit: a pilot study of a smoking cessation programme tailored to gay men
Acronym
Study hypothesis
1. Attendance of a seven-week smoking cessation programme tailored to gay men enhances their abstinence rates six months after programme attendance, as measured by seven-day point prevalence smoking abstinence.
2. Attendance of a seven-week smoking cessation programme tailored to gay men reduces their consumption of other drugs as well as their anxiety and depression levels, and increases their mental and physical health.
Ethics approval
Following investigation with the Cantonal Ethical Committee of Zurich, the study does not meet the criteria requiring formal ethical approval as we do not administer drugs or do not perform the study in a hospital, nursing home or institution of justice (www.kek.zh.ch)
Study design
Pilot study without a control group
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cigarette smoking
Intervention
We aim at a minimum of five groups with 15 participants each.
The programme consists of seven weekly closed-group sessions, each lasting 2.5 hours. Sessions 1 and 2 of the programme have an educational focus. These sessions are mainly managed by the facilitator. To support participants in seeking medication, a letter addressed to their general practitioners announcing participants' attendance in the programme and requesting a prescription of nicotine replacement therapy (NRT) or other prescription medicine is made available. Smoking cessation at session 3 ('quit day') is mandatory for all participants. From 'quit day' in session 3 onwards, priority is given to the social component of the programme. Peer support is reinforced by shifting from vertical (facilitator) to horizontal peer support (quit teams). Carbon monoxide (CO) measures are taken in each session using a breath carbon monoxide monitor to confirm smoking cessation, monitor smoking abstinence and visualise physical health improvements. In addition, participants have to indicate the number of cigarettes smoked in the previous 7 days and the type and the number of units used of NRT during the previous week, if any. These assessments are understood as part of the programme to make participants aware of their progress.
Week 1: Facts about smoking and smoking cessation; What can you expect when you quit smoking? Minimise the side effects - NRTs and prescription medication; Contraindications for prescription medication; What about prescription medication and HIV anti-retroviral therapy? The issues of combination usage of NRT and prescription medication
Week 2: Are you ready to stop smoking? Carbon monoxide and what it does to you; Carbon monoxide monitor; Stop Smoking action plan; Smoking diary; Preparing for Quit Day
Week 3: Quit Day; Quit Team Contact Sheet
Week 4: Inexpensive holistic stop-smoking ideas
Week 5: Weight gain issues
Week 6: Your support network
Week 7: Celebration
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Seven-day point prevalence smoking abstinence six months following the last program session via the question: Have you smoked during the past seven days?
Secondary outcome measures
1. Depression [Beck Depression Inventory (BDI-V)] measured at baseline, session 7 and at the six-month follow-up
2. Anxiety [Beck Anxiety Inventory (BAI)] measured at baseline, session 7 and at the six-month follow-up
3. Mental and physical health [Short-Form Health Survey (SF-12)] measured at baseline, session 7 and at the six-months follow-up
4. Alcohol and drug use in the previous 30 days (European Addiction Severity Index)
Overall trial start date
01/01/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Smoking, gay men or men who have sex with men older than 18 years with strong intentions to quit
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
75
Participant exclusion criteria
N/A
Recruitment start date
01/01/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Switzerland
Trial participating centre
Swiss Research Institute for Public Health and Addiction ISGF
Zürich
8031
Switzerland
Funders
Funder type
Government
Funder name
Federal Office of Public Health (FOPH) (Switzerland) - Swiss Tobacco Control Fund; Grant No. 08.002268
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24498915