Randomised trial of two nicotine patch protocols distributed through a state quitline

Tob Control. 2016 Mar;25(2):218-23. doi: 10.1136/tobaccocontrol-2014-051843. Epub 2014 Nov 21.


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.

Keywords: Cessation; Economics; Health Services.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Cost-Benefit Analysis
  • Drug Costs
  • Female
  • Government Regulation
  • Humans
  • Local Government
  • Male
  • Middle Aged
  • Nicotine / administration & dosage*
  • Nicotine / economics
  • Nicotinic Agonists / administration & dosage*
  • Nicotinic Agonists / economics
  • Preventive Health Services / economics
  • Preventive Health Services / methods*
  • Smoking / adverse effects
  • Smoking / economics
  • Smoking / psychology
  • Smoking Cessation / economics
  • Smoking Cessation / methods*
  • Smoking Cessation / psychology
  • Smoking Prevention*
  • Time Factors
  • Tobacco Use Cessation Devices* / economics
  • Tobacco Use Disorder / diagnosis
  • Tobacco Use Disorder / economics
  • Tobacco Use Disorder / prevention & control*
  • Tobacco Use Disorder / psychology
  • Transdermal Patch
  • Treatment Outcome
  • Young Adult


  • Nicotinic Agonists
  • Nicotine

Associated data

  • ClinicalTrials.gov/NCT01889771