Nicotine dependence.
Conditions
Interventions
Trade Name: NiQuitin CQ 4mg Mint Lozenge
Product Name: Nicotine Mint 4 mg Lozenge
Pharmaceutical Form: Compressed lozenge
Other descriptive name: Nicoti
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age - Aged between 21-55 years, inclusive. 2) Weight - BMI within the range 19-32 kg/m2. 3) Smoking Status a) Cigarette smokers that consume their first manufactured cigarette within 30 minutes of waking. b) Individuals who have smoked regularly for at least a year. 4) Contraception - Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. 5) Compliance - Understands and is willing, able and likely to comply with all study procedures and restrictions. 6) Consent - Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 7) General Health - Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnancy - Females that are pregnant (as shown by a positive urine pregnancy test at screening or treatment visit). 2) Breast-feeding - Women who are breast–feeding. 3) Contraception - Females of childbearing potential who are not practising an acceptable (in the opinion of the investigator) method of birth control. 4) Allergy/Intolerance - Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 5) Colour blindness - Known colour blindness or failure to pass a colour blindness test at screening. 6) Clinical Study/Experimental Medication a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study. b) Previous participation in this study. 7) Substance abuse - Current or recent history (within the last 1 year) of alcohol (i.e. consumption of more than 21 units alcohol per week for females, 28 units of alcohol per week for males) or other substance abuse. Positive drugs of abuse urine screening at the screening or study visit. 8) Alcohol - Consumption of any alcoholic beverages within 24 hours of the treatment visits (as indicated by either a positive breath alcohol test or in the opinion of the Investigator). 9) Caffeine - Consumption of large quantities of xanthine containing beverages (e.g., coffee, tea , cola, chocolate etc, more than an average of 5 cups or glasses per day). 10) Disease - Any disease that, in the opinion of the investigator, may interfere with the absorption, metabolism or excretion of the study product. A medical history that, in the opinion of the investigator, might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia, history of significant neurological or mental illness. 11) Allergy/Intolerance - History of Adverse Events (AEs) associated with nicotine replacement products, nicotine or lozenge use. 12) Prior/Concomitant Medication a) Treatment with known enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the study visit. b) Use of any prescription psychoactive medication (such as, but not limited to, anti-depressants, anxiolytics and anti-psychotics) within 14 days of the study visit. c) Use of any OTC medication within 24 hours of the study visit. d) Current use of any nicotine replacement therapy. 13) Personnel - An employee of the sponsor or the study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the effect of the 4 mg nicotine mint lozenge to placebo on ability to concentrate, as measured by the Rapid Visual Information Processing (RVIP) test.; Secondary Objective: The secondary objectives are to compare the effect of the 4 mg nicotine mint lozenge to placebo on - Selective attention and alertness, as measured by the Stroop test; - Short-term memory, as measured by the Sternberg Short Term Memory (STM) Scanning Test; - Psychomotor function, as measured by the Compensatory Tracking Test (CTT); - Sensorimotor performance, as measured by the Choice Reaction Time (CRT) test. Another secondary objective is to assess safety by the incidence and intensity of adverse events. ;Primary end point(s): The 4 mg nicotine mint lozenge will be declared superior to placebo for effect on ability to concentrate if the comparison in the primary analysis on Rapid Visual Information Processing mean valid reaction time shows significance at the 0.05 (2-sided) level. | — |
Countries
United Kingdom
Outcome results
None listed