Randomised trial of two nicotine patch protocols distributed through a state quitline
Emily K Burns1, Nancy E Hood2, Emma Goforth3
1Mercy Family Medicine, Mercy Regional Medical Center, Centura Health, Durango, Colorado, USA.
Background:
Most telephone quitlines provide free nicotine replacement therapy (NRT). An 8-week course is recommended, but few users complete it. Information is needed to help quitlines distribute NRT cost-effectively.
Design:
Randomised two-group trial.
Setting/Participants:
Colorado QuitLine callers who smoked 16-20 cigarettes per day at enrolment and who were eligible for and agreed to receive free NRT.
Intervention:
Provision of 4-week versus 8-week NRT supply; the 8-week supply was shipped in halves and required participants to request the second half (split-shipment protocol). Enrolment occurred during March 2010-February 2011, follow-up concluded in November 2011, and analysis was performed in 2012.
Main Outcome Measures:
Point abstinence (7 and 30 day) and prolonged abstinence (6 month) from tobacco use.
Results:
Overall, 1495 study participants were enrolled and 57.7% completed follow-up. Abstinence rates did not differ significantly between study conditions: 13.8% versus 12.4% in 4-week versus 8-week arms, respectively, (30-day point abstinence, non-respondents treated as smokers). NRT duration was similar in both groups, due in part to purchase of additional patches in the 4-week group. About one-third of the 8-week group requested the full 8-week supply and had higher abstinence rates. Cost per quit was lower in the 4-week (compared to 8-week) group.
Conclusions:
A randomised trial did not find worse cessation outcomes among quitline users who received half the minimum recommended course of NRT, but offering the full recommended course using a split-shipment protocol may be reasonably cost-effective and supportive of NRT adherers.
Trial Registration Number:
NCT01889771.
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