They still don't get it apparently - study protocol for smoking cessation with ecigs vs patch

[TomCatt]

Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

Methods/design
Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups.

Not too sure where I'd be if I quit vaping 3 months after starting

But at least it's a start if they do go forward with this type of study.

 

[DaveP]

The patch doesn't have an admirable quit rate one year after use. Ecigs rate about 80% for those who continue to use them for a long period after quitting tobacco and offer a non-prescription titration method to voluntarily lower the nic level as needed to get to zero nic.

 

[Vocalek]

This is the study that might give us a better answer about how things work in the real world. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363281

Can using nicotine as a long-term substitute enhance smoking cessation over using it only as a cessation aid?

 

[Vocalek]

About the OP study:

Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups.

Those seem like odd numbers for the sample sizes. I wonder if the study is already under way and if those are the numbers they ended up with after randomization.

 

[dave8944]

About the OP study:



Those seem like odd numbers for the sample sizes. I wonder if the study is already under way and if those are the numbers they ended up with after randomization.

It looks like it's just proposal, and those numbers are a power analysis to determine the best sample size for detecting a difference. Most grant proposals now days must include such an analysis to justify their sample sizes (and costs associated with including that many people in the study). The power of a test is the probability of being able to reject the null hypothesis (that there is no difference) if in reality the null hypothesis is false. So, it's the numbers needed in order to have a reasonable chance of detecting a difference if there really is a difference. Power of 80% is a fairly standard goal since going any higher requires exponentially more participants.

 

[Vocalek]

Thanks for the explanation!