icoNovum Evaluation of Withdrawal Relief Study Part 2

Phase 3

Recruiting

• Conditions: Smokers; Public Health - Health service research; Mental Health - Addiction

• Registration Number: ACTRN12607000086460
• Lead Sponsor: Professor Peter Hajek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in composite craving score over time.[15 minutes and 5 minutes prior to taking product. 5, 10, 15, 20, 25, 30, 40, 50, 60 minutes after taking product.]

Secondary Outcome Measures

Name	Time	Method
Change in individual withdrawal symptoms over time.[Measured 15 and 5 minutes before taking product and 5, 10, 15, 20, 25, 30, 40, 50, 60 minutes after taking product.];Comparison of subjective ratings of product[Measured 12 hours after taking product];Helpfulness and satisfaction[Measured 12 hours after taking product];Comparison of side effects[Measured 12 hours after taking product];Comparison of plasma nicotine concentrations and relationship with withdrawal relief.[Plasma nicotine will be measured 30 mins prior to taking product; 5, 10, 30 and 60 minutes after taking product.]