Condition category
Mental and Behavioural Disorders
Date applied
16/03/2017
Date assigned
18/05/2017
Last edited
12/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nicotine replacement treatment (NRT) is widely used to help people quit smoking, but it’s not effective for everyone. This may be, in part, because many smokers receive less nicotine from NRT than smoking. There is some evidence that higher dosing and the use of NRT before actually quitting smoking may help. This is because nicotine from NRT may weaken the association between smoking behaviour and the nicotine reward from cigarettes, and in turn reduce the desire to smoke. A potentially promising approach would be to increase the NRT dose before quitting, with the aim of achieving nicotine levels which make smoking unrewarding or even unpleasant. The aim of this study is to examine the acceptability, safety, and potential efficacy of an personalized program which increases NRT (iNRT) dosing to help people quit smoking.

Who can participate?
Adult smokers who want to quit and are willing to use nicotine patches.

What does the study involve?
All participants are given nicotine patches to use for four weeks before their target quit date and for four weeks afterwards. In the four weeks before they quit, the dose of nicotine patches is increased every week if the smoker does not report any side effects, such as feeling sick. The maximum dose given can be up to 84mg/day. Over the four weeks after the quit date, the patch dose is reduced to standard levels (21mg/day). The number of participants who progress through each stage of the dosing schedule are recorded as well as those who are sticking to the treatment. In addition, participants are interviewed about changes in smoking rate and enjoyment of smoking, withdrawal symptoms, and the quit rate at 4 weeks after the target quit date.

What are the possible benefits and risks of participating?
Participants may benefit from being able to successfully quit smoking. there are no notable risks involved with participating. If participants experience any severe side effects from the nicotine patch, they will be asked to either stop altogether or reduce the dose.

Where is the study run from?
Emphysema Foundation (Argentina)

When is the study starting and how long is it expected to run for?
December 2016 to August 2018

Who is funding the study?
Global Research Awards for Nicotine Dependence (UK)

Who is the main contact?
1. Dr Dunja Przulj (scientific)
2. Dr Luis Wehbe (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dunja Przulj

ORCID ID

Contact details

Health and Lifestyle Research Unit
Queen Mary University of London
2 Stayner's Road
London
E1 4AH
United Kingdom

Type

Scientific

Additional contact

Dr Luis Wehbe

ORCID ID

Contact details

Carlos Alvear 3345
Mar del Plata
Buenos Aires
CP7600
Argentina

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.1 10 Oct 2016

Study information

Scientific title

Increasing the dose of Nicotine Replacement Treatment to individual needs: A pilot study

Acronym

iNRT

Study hypothesis

The aim of this study is to examine the feasibility and acceptability of increasing the dose of nicotine patches used prior to a smokers target quit date (TQD) in order to establish what proportion of smokers are likely to progress to different levels of dose increase and what, if any, side effects they may report.

Ethics approval

Joint Commission on Health Research (Comisión Conjunta de Investigación en Salud- CCIS), Beunos Aires, Argentina, 24/01/2017, ref: 2919/1419/2016

Study design

Open-label single-site non-randomised pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Smoking cessation

Intervention

Smokers wanting to give up will be given nicotine patches to use for 4 weeks prior to their target quit day and for 4 weeks during their quit attempt. In the four weeks prior to their target quit day, the dose of nicotine patches will increase each week if the smoker does not report any reaction to it (e.g. nausea). The maximum dose used could be up to 84mg/day (i.e. the participant would wear 4 patches a day). Over the 4 weeks after the quit day, the patch dose will be reduced to standard levels (21mg/day, i.e. 1 patch per day). The total duration of the intervention is 8 weeks. There is no further follow-up of participants after this.

Intervention type

Drug

Phase

Not Applicable

Drug names

21mg/24hr Nicotine Transdermal Patch

Primary outcome measure

Feasibility of the intervention is assessed by recording the proportion of participants who progress through each stage of increased dosage (42mg, 63mg and 84mg) over the four weeks prior to their Target Quit Day.

Secondary outcome measures

1. Adherence to treatment will be assessed by examining the frequency of patch use over the 8 weeks and the number of participants who stop using their patches over the 8 weeks
2. Acceptability and helpfulness of the intervention will be measured by asking participants to rate (1-5) how helpful they found their patch over the last week, at each session; and by looking at the frequency of any adverse effects and their intensity
3. Potential efficacy of the intervention will be measured by examining validated abstinence rates at the end of the 8 weeks, changes in carbon monoxide readings, cigarette consumption, enjoyment of smoking and withdrawal symptoms over the first 4 weeks prior to the TQD; and changes in withdrawal symptoms over the 8 weeks

Overall trial start date

14/12/2016

Overall trial end date

31/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18-65 years of age
2. Daily smoker
3. Seeking treatment to quit smoking and willing to use nicotine patches

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Pregnant/breastfeeding or planning to conceive in the next 3 months
2. Previous adverse reaction to the nicotine patch
3. Serious medical condition including, cancer and psychiatric illness
4. History of Myocardial infarction
5. Cannot read, write or understand Spanish
6. Current involvement in other interventional research

Recruitment start date

01/04/2017

Recruitment end date

31/07/2017

Locations

Countries of recruitment

Argentina

Trial participating centre

Emphysema Foundation (Fundación Enfisema)
Carlos Alvear 3345 Mar del Plata
Buenos Aires
CP7600
Argentina

Sponsor information

Organisation

Fundación Enfisema

Sponsor details

Carlos Alvear 3345
Mar del Plata
Buenos Aires
CP7600
Argentina

Sponsor type

Other

Website

Funders

Funder type

Research organisation

Funder name

Global Research Awards for Nicotine Dependence (GRAND)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Dunja Przulj, d.przulj@qmul.ac.uk

Intention to publish date

31/08/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes