Examination of mechanism of action of pre-quit use of nicotine patch and varenicline for smoking cessation

Effect of treatment with pre-quit nicotine patch or pre-quit varenicline or standard nicotine patch for regular daily smokers aged over 18 on abstinence at four weeks

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000329662

Acronym

PQT

Enrollment

216

Registered

2014-03-27

Start date

2014-03-27

Completion date

2016-05-19

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

Brief summary

The primary objective of the proposed study is to test the mechanism of action of two pre-quit smoking cessation medications - varenicline and nicotine patch – in order to learn how best to optimize these pre-quit treatments.

Interventions

Varenicline 6 weeks, including 2 weeks prior to a set quit date; oral dose 0.5 mg once daily for 3 days, 0.5 mg twice daily for 4 days, 1 mg twice daily for weeks 2-6. or Nicotine patch 21mg/24 hours 6 weeks, including 2 weeks prior to a set quit date. Daily monitoring adherence via participant study phone device

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

a) greater than or equal to 18 years old; b) smoke greater than or equal to 15 cigarettes per day for the past three years; c) have high motivation to quit smoking (75/100); d) be willing and able to use either patches or varenicline as part of a quit attempt.

Exclusion criteria

a) are currently enrolled in a smoking cessation trial, or have been within the past three months; b) are unsuitable for treatment with either patches or varenicline (per prescribing guidelines).

Outcome results