Condition category
Mental and Behavioural Disorders
Date applied
23/09/2013
Date assigned
02/10/2013
Last edited
10/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Federal Office of Public Health (FOPH) (Switzerland)

Sponsor details

Swiss Tobacco Control Fund (Tabakpräventionsfonds)
Postfach
Bern
3003
Switzerland

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24498915

Publication citations

Additional files

Editorial Notes