A randomized clinical trial of a financial education intervention with nicotine replacement therapy (NRT) for low socio-economic status Australian smokers: a study protocol.

What Was Tested

This randomized controlled trial looks at Therapeutic nicotine (patch, non-peptide).

Financial stress (e.g. shortage of money or inability to pay bills) may be a major barrier to quitting smoking.

Who Took Part

A two-group parallel block randomized (ratio 1: 1) open-label clinical trial (RCT) with allocation concealment will be conducted.

Nicotine replacement therapy (NRT) delivery will be mail-based.

How the Study Was Run

The design is described as randomized, open-label and parallel-group.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Allocation will be concealed to interviewers at data collection-points.

The study will be conducted primarily by telephone with baseline, follow-up interviews and telephone-based support sessions.

After completion of a baseline computer-assisted telephone interview, participants will be allocated randomly to control or intervention group using a permuted block approach.

Participants in both groups will receive 8 weeks of free combination NRT plus Quitline support.

Participants in the intervention group will also receive four telephone-delivered financial education and support sessions.

What Was Measured

The primary outcome measure will be prolonged abstinence (at 8-month follow-up) assessed using Russell Standard criteria and biochemically verified (urine cotinine).

Topics PubMed links to this paper include Australia, Cotinine, Financial Management, Hotlines, Poverty, Smoking and Smoking Cessation.

The authors tagged it with the keywords Intervention studies, intervention studies, low income population, randomized controlled trial, social class and socio-economic factors.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Therapeutic nicotine (patch, non-peptide).

Results are reported in around 2 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2014 (Addiction (Abingdon, England)), a journal based in England.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.