RecruitingPhase 3ACTRN12607000086460

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.


Sponsor

Professor Peter Hajek

Enrollment

52 participants

Start Date

Feb 23, 2006

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests new nicotine replacement products — a nicotine mouth spray and a nicotine lozenge — to see how quickly and effectively they relieve the discomfort people feel when they stop smoking (withdrawal symptoms). These new products are compared to nicotine gum (an existing product) and a dummy product with no nicotine. The study also asks how satisfied people feel after using each product. Faster nicotine delivery might better ease the urge to smoke. You may be eligible if: - You are between 18 and 70 years old - You smoke at least 15 cigarettes per day and have done so for at least one year - You usually smoke within 30 minutes of waking up - You are in generally good health - You can attend the study site on the same day each week for 4 weeks - You can read and write in English You may NOT be eligible if: - You have had a heart attack, angina, or serious illness in the last 6 months - You have diabetes - You have a current psychiatric disorder - You are pregnant or breastfeeding - You weigh less than 45 kg or more than 120 kg - You have high blood pressure (above 180/100 mmHg) - You currently use nicotine products other than cigarettes - You take certain medications including clonidine, bupropion, or other psychotropic drugs Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

New Zealand

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