NicoNovum Evaluation of Withdrawal Relief Study Part 2
A phase III, single blind, randomised, cross-over trial of the effects of a novel nicotine replacement therapy (NicoNovum mouthspray and lozenge)in the treatment of withdrawal relief in smokers.
Professor Peter Hajek
52 participants
Feb 23, 2006
Interventional
Conditions
Summary
The study has been designed to test how effectively and rapidly a number of new nicotine replacement treatments - nicotine mouthspray and lozenge - relieve the discomfort that people experience when they stop smoking (called withdrawal symptoms) compared to a currently available nicotine replacement product (nicotine gum) and a “dummy” (placebo) product (with no nicotine in it). These new products may deliver nicotine to the body faster than existing products, and it is thought that faster delivery of nicotine may help reduce the discomfort that goes along with stopping smoking. The study will also ask about the level of satisfaction people experience after using the different products.
Eligibility
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Interventions
Niconovum nicotine mouthspray (1mg/spray - 3 spray dose). Mode of administration: Spray between cheek and gum. Niconovum nicotine lozenge (2.5mg). Mode of administration: dissolve in mouth - do not chew. This trial has a crossover design with each product used for 12 hours, with washout period of three days. Total trial time (due to staggered design) - 4 weeks.
Locations(1)
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ACTRN12607000086460