Plain English Summary
Background and study aims
This study would like to find out if a non-deceptive non-concealed placebo patch (that is a patch that contains no active ingredients) will help people reduce the number of cigarettes that they smoke. A placebo is something that looks like a real medical treatment, but isn’t. It could be a pill for example, or another type of “fake” treatment. Placebos do not contain any active substances that have been developed to improve health. Researchers often use placebos to help them understand the effects of a new treatment (by comparing the effects on participants taking the new drug with those taking the placebo). However, some people do respond to a placebo. This Is referred to the placebo effect and there are some cases where it happens even when a person knows that they are taking a placebo. It is seen as a possible explanation for why some patients have a greater chance of a good outcome when given a dummy pill rather than being given nothing at all. It is also a possible explanation of why some patients still believe in treatments that are known not to work or are not clinically proven. This could be due to belief or the powers of suggestion, which might be a very important aspect of a treatment. This study looks at whether given a patch known to be a placebo to smokers helps them to reduce the number of cigarettes that they smoke.
Who can participate?
Adults that have smoked for at least 2 years and want to stop smoking.
What does the study involve?
All participants are told before starting the study that the best way to stop smoking (and therefore reduce their dependence on nicotine) is to reduce the number of cigarettes that they smoke over time. Participants are randomly allocated to one of two groups. Those in group 1 (the placebo patch group) are given a 56 day supply of placebo smoking cessation patches. They are all told that the patches are placebos and are monitored for 56 days to see whether they reduce the number of cigarettes that they smoke. Those in group 2 (control group) are not given any patches but are also monitored for 56 days to see whether they reduce the number of cigarettes that they smoke.
What are the possible benefits and risks of participating?
It is possible that participating in this study will help in reducing the number of cigarettes that a person smokes. The main risk to participating is nicotine withdrawal symptoms.
Where is the study run from?
University of Santo Tomas (Philippines)
When is the study starting and how long is it expected to run for?
January 2015 to October 2015
Who is funding the study?
Investigator initiated and funded (Philippines)
Who is the main contact?
Mr Kevyn Yu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An open-label randomized interventional study to assess the effect of placebo smoking cessation patches versus no treatment on nicotine dependence scores of adult Filipino smokers
Acronym
Study hypothesis
Ho: There would be no significant difference in the delta FTND (Fagerstrom test for Nicotine Dependence) scores between placebo treatments as compared to no treatment
Hi: There would be a significant difference in the delta FTND scores between a placebo patch treatment as compared to no treatment
This study asks the question: How significant is the difference in FTND score delta when a placebo is suggested as a Smoking cessation agent versus no treatment at all?
Ethics approval
University of Santo Tomas Faculty of Pharmacy Ethics Review Committee, 07/07/2015
Study design
Open-label randomized interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
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 addiction
Intervention
There were two arms in the study, the placebo patch group and the control group.
1. Both groups:
1.1. Gave informed consent
1.2. Were within the inclusion and exclusion criteria of the study
1.3. Were told that the safe way to decrease nicotine dependence,was to incrementally reduce cigarette smoking with time
1.4. Data gathering by a blinded assessor
2. Placebo patch group:
2.1. Were given 56 day supply of placebo smoking cessation patches
2.2. Were told to apply the patches daily for 56 days
2.3. Were explicitly told that the patches given were placebos and had no active ingredient but were for reducing nicotine dependence
2.4. Were monitored for a 56 day period, with data gathering for nicotine dependence on days 0, 28 and 56
3. Control group were monitored for a 56 day period, with data gathering for nicotine dependence on days 0, 28 and 56
Intervention type
Other
Phase
Drug names
Primary outcome measures
Nicotine dependence, measured using the Fagerstrom test for Nicotine Dependence(FTND) at 0,28 and 56 days after provision of patches
Secondary outcome measures
Cigarettes per day, measured at 0,28 and 56 days after provision of patches
Overall trial start date
15/01/2015
Overall trial end date
29/10/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1.18 years or older
2. Male or female
3. Current smoker for 2 years
4. Very willing to quit smoking when assessed with 5 point commitment scale
5. Willing to use the placebo patch for a period of 2 months
6. Ethnically Filipino and currently residing in Sampaloc, Manila
7. Has signed the informed consent form and is aware of the purpose of the study
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Taking other smoking cessation treatment/ treatments (e.g. nicotine patches or gum)
2. Is under or have underwent smoking cessation counseling
Recruitment start date
10/07/2015
Recruitment end date
29/07/2015
Locations
Countries of recruitment
Philippines
Trial participating centre
University of Santo Tomas
España, Quezon Dr
Sampaloc, Manila
1008
Philippines
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plos One
Intention to publish date
29/02/2016
Participant level data
Not expected to be available
Results - basic reporting
Publication summary
N/A