Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact upon adherence

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000106-24-GB

Enrollment

630

Registered

2006-03-20

Start date

2006-06-26

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking addiction

Interventions

Trade Name: Nicorette 2mg Gum Pharmaceutical Form: Oral gum Trade Name: Nicorette 4mg Gum Pharmaceutical Form: Oral gum Trade Name: Ni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1. Regular cigarette smokers, defined as those smoking an average of 10 or more cigs/day (including roll-ups) over the preceding 12 months, who want to stop smoking 2. Aged 18 years or older, 3. Male or female 4. Able to give informed consent to participate. 5. Able to complete, either alone or with assistance, the study questionnaires Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1.Cigar, pipe and oral tobacco users who do not also smoke 10 or more cigarettes per day. 2.Those who meet contraindications for NRT use as described in the Summary Product Characteristics. Although not all forms of NRT is not contra-indicated in pregnancy or lactation, the metabolism of nicotine changes and there remain concerns about safety in this group (being specifically addressed in a current RCT). Therefore pregnant or lactating women or those who plan to get pregnant during the course of treatment will be excluded. . 3.Those with previous severe adverse reactions to NRT patch or to oral NRT. 4.Currently taking medication for smoking cessation that they are unwilling to cease taking or medication with a known influence on smoking cessation that they cannot stop (e.g. nortriptyline for depression).

Design outcomes

Primary

Measure	Time frame
Main Objective: The trial objective is to describe the impact upon adherence of feedback on genotype and using genotype to tailor nicotine replacement therapy. Adherence to NRT is defined as the proportion of prescribed medication that is taken. The trial will test two hypotheses: The primary hypothesis Adherence is greater when given feedback that NRT is tailored to genotype as opposed to heaviness of smoking ; Secondary Objective: The secondary hypothesis Among the majority of smokers who relapse, motivation to make another quit attempt is lower when given feedback that NRT was tailored to genotype (as opposed to heaviness of smoking) in the previous unsuccessful attempt. ; Primary end point(s): Primary outcome The primary outcome will be the proportion of all NRT consumed in the first four weeks of quitting or to the point of relapse, whichever is the sooner. This will be measured by self-report daily diary, backed up by 'pill count reconciliation with the diary at the clinic. If pill counts are discrepant with the diary, this will be discussed and reconciled at the clinic visit. A patch will be counted as worn if it is worn for at least 8 hours in any day. An oral product will be counted as used if it is put into the mouth. Typically in smoking cessation studies, patients cease attending the clinic on relapse back to smoking, thus there will be a maximum of 7 days when no reported adherence measures will be available in a quit history. If a participant does not keep a scheduled appointment, the clinic nurse will seek telephone contact to establish smoking status and adherence between clinic and relapse, should that have occurred. If no such data are available, the adherence data up to date of last follow up will be used. For both groups, weighted group means of these proportions will be calculated with	—

Measure

Time frame

Main Objective: The trial objective is to describe the impact upon adherence of feedback on genotype and using genotype to tailor nicotine replacement therapy. Adherence to NRT is defined as the proportion of prescribed medication that is taken. The trial will test two hypotheses: The primary hypothesis Adherence is greater when given feedback that NRT is tailored to genotype as opposed to heaviness of smoking ; Secondary Objective: The secondary hypothesis Among the majority of smokers who relapse, motivation to make another quit attempt is lower when given feedback that NRT was tailored to genotype (as opposed to heaviness of smoking) in the previous unsuccessful attempt. ; Primary end point(s): Primary outcome The primary outcome will be the proportion of all NRT consumed in the first four weeks of quitting or to the point of relapse, whichever is the sooner. This will be measured by self-report daily diary, backed up by 'pill count reconciliation with the diary at the clinic. If pill counts are discrepant with the diary, this will be discussed and reconciled at the clinic visit. A patch will be counted as worn if it is worn for at least 8 hours in any day. An oral product will be counted as used if it is put into the mouth. Typically in smoking cessation studies, patients cease attending the clinic on relapse back to smoking, thus there will be a maximum of 7 days when no reported adherence measures will be available in a quit history. If a participant does not keep a scheduled appointment, the clinic nurse will seek telephone contact to establish smoking status and adherence between clinic and relapse, should that have occurred. If no such data are available, the adherence data up to date of last follow up will be used. For both groups, weighted group means of these proportions will be calculated with

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026