A Trial of Pre-Quitting Nicotine Replacement Therapy

A single blind randomised controlled trial comparing the use of Nicotine Replacement Therapy (NRT) while still smoking for 2 weeks prior to quitting followed by usual NRT practice, with usual NRT cessation practice on smoking abstinence at 6 months.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000373673

Enrollment

1100

Registered

2005-09-13

Start date

2006-03-06

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

The study is a single blind randomised controlled trial of Nicotine replacement therapy (HABITROL: patches and/or gum)while still smoking for two weeks prior to Quit Day followed by usual practice, versus usual practice. Usual practice comprises an 8 week programme of NRT patches and or gum and support calls (eg Quitline) or face to face visits for other cessation providers (eg Aukati Kai Paipa), commencing on Quit Day.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants will be smokers from throughout New Zealand, who are interested in quitting within the next few days or at most within 2 weeks. Participants will be eligible for inclusion in the trial provided that they are eligible for subsidised NRT according to Quitline criteria. These are as follows: at least 18 years of age, have their first cigarette within 30 minutes of waking (a measure of nicotine dependency)have a telephone, and are able to provide consent.

Exclusion criteria

People will be excluded from the trial if they meet any of the criteria used by Quitline and other cessation providers to decline NRT or to seek medical approval. These are as follows:are pregnant or breastfeedingare current users of NRT productsuse non-cigarette tobacco products (e.g. snuff, pipes, cigars)Is not currently using Zyban (Buproprion) or Nortriptylinehave had a stroke or heart related condition in the last 3 months.

Outcome results