RELIQ Study: Reduced levels of nicotine in cigarettes to increase quitting

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000410358

Acronym

RELIQ

Enrollment

1410

Registered

2008-08-21

Start date

2009-04-01

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

Brief summary

Smoking is the leading cause of lost healthy life years in New Zealand. Although smoking prevalence has been slowly declining in recent years (2002/3: 23% in adults, 2006/7: 19% in adults4), it remains particularly high in Maori (2007: 40% Maori women, 35% Maori men) and additional options for smokers who want to quit are needed. Although a variety of methods are available to help people stop smoking, many of them are expensive, have side effects, and despite their use most quit attempts still fail. There is some evidence that progressive reduction in the level of nicotine in cigarette tobacco can reduce the level of nicotine dependence in smokers, without any compensatory smoking9. Furthermore, evidence suggests that the use of NRT in combination with nicotine-free cigarettes may have an impact on the signs and symptoms of withdrawal and cessation rates. The proposed trial will test the balance of benefits and risks of a new strategy for people to overcome nicotine addiction, namely the combined use of nicotine-free cigarettes and NRT immediately after quitting. If the study confirms that the intervention in question is an effective time-limited smoking cessation strategy, then further research can be undertaken to determine the implications of these research findings on current policy and practice. If proven safe and effective this strategy is likely to have substantial public health benefits.

Interventions

1. Nicotine replacement therapy (NRT) (eg patches and or gum or lozenges) as directed by smoking cessation adviser and reduced nicotine cigarettes (containing<= 0.05 mg nicotine per cigarette) 2. Duration of 6 weeks for nicotine free cigarettes (as required, eg 800 cigarettes) and 8 weeks for the NRT given concurrently.

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

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.

Outcome results