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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000086460

Acronym

NEWS Part 2

Enrollment

Registered

2007-01-25

Start date

2006-02-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria:Smoke =15 cigarettes per day for the last year Smoke within 30 minutes of wakingSelf-report being in good health with verification by medical history. Be able to attend the study site for 4 weeks on the same day of the week. Be able to read and write English. Participants are capable of giving informed consent.

Exclusion criteria

Exclusion criteria:Recent (within 6 months) myocardial infarction, angina pectoris, or other serious medical condition Diabetes mellitus Previous severe allergic reactionCurrent chemical dependence other than nicotine Current psychiatric disorder. Chronic oral disorder. Pregnant (will have negative urinary dipstick for beta - human chorionic gonadotropin (ßHCG) Breast feeding. Weight less than 45 kg or over 120 kgUrine dipstick positive for glucoseBlood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolic Current use of nicotine products other than cigarettes Any condition that would preclude proper use of nicotine gum. Current use of clonidine, buspirone, doxepin, bupropion, fluoxetine or other psychotropic drug. Participants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (exhaled carbon monoxide (CO) verified)

Outcome results