E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Completion of the clinical phase will be defined as last subject, last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |