ACTRN12608000410358CompletedPhase 3
A single-blind randomised controlled trial of nicotine-free cigarettes as an adjunct to usual nicotine replacement therapy (NRT)-based cessation practice (patch, gum and/or lozenge), in people who wish to stop smoking.
Heath Research Council NZ0 sites1,410 target enrollmentStarted: August 21, 2008Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,410
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1. they want to stop smoking
- •2. they are at least 18 years of age
- •3. their time to first cigarette is within 30 minutes of waking
- •4. they are able to provide verbal consent
- •5. they have access to a telephone
Exclusion Criteria
- •Pregnant and breastfeeding women and smokers who have had a heart attack, stroke, or unstable angina within the last two weeks will be excluded, as will smokers who are current users of NRT products, those who use only non-cigarette tobacco products (e.g. pipes, cigars), those who are currently using non nicotine-based cessation therapies (e.g. buproprion [Zyban], clonidine, nortriptyline, or varenicline [Champix]), and those who are current clients of Txt2Quit and NRT Online.
Investigators
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