Increasing the dose of nicotine replacement treatment to individual needs

• Register: ISRCTN
• Last refreshed on: 2 September 2019
• Main ID: ISRCTN24872175
• Date of registration: 18/05/2017
• Prospective Registration: No
• Primary sponsor: Fundación Enfisema
• Public title: Increasing the dose of nicotine replacement treatment to individual needs
• Scientific title: Increasing the dose of Nicotine Replacement Treatment to individual needs: A pilot study
• Date of first enrolment: 01/04/2017
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN24872175
• Study type: Interventional
• Study design: Open-label single-site non-randomised pilot study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Argentina

Contacts

• Name: Dunja Przulj

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Smoking cessation
Mental and Behavioural Disorders
Smoking cessation

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

Version 1.1 10 Oct 2016

Source(s) of Monetary Support

Global Research Awards for Nicotine Dependence (GRAND)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/08/2018