Simultaneous fMRI/EEG of the 4 mg nicotine lozenge in relief of cognitive impairment associated with nicotine withdrawal

• Conditions: icotine dependence; MedDRA version: 9.1Level: LLTClassification code 10057852Term: Nicotine dependence

• Registration Number: EUCTR2007-002374-55-GB
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Age - Aged between 18 and 55 years inclusive.
2)Weight
a)BMI within the range 19.0-32.0 kg/m2.
b)Able to fit comfortably within the MR scanner.
3)Smoking Status
a)Cigarette smokers that consume their first manufactured cigarette (i.e., not self rolled cigarettes) within 30 minutes of waking.
b)Individuals who have smoked regularly for at least a year.
4)General Status
a)Right handed subjects.
b)Able to read and write (in English) at a level sufficient to complete study-related assessments.
5)Contraception - Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
6)Compliance - Understands and is willing, able and likely to comply with all study procedures and restrictions.
7)General Health - Good general health with (in the opinion of the examining study doctor) no clinically significant and relevant abnormalities of medical history or physical examination.
8)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.

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

1)Pregnancy - Women who are pregnant or who have a positive urine pregnancy test.
2)Breast-feeding - Women who are breast–feeding.
3)Disease/Illness
a)Any clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG at screening which, in the opinion of the investigator, could interfere with the interpretation of efficacy or safety data or which otherwise would contraindicate participation in a clinical.
b)Current or recent history or presence of a neurological diagnosis (not limited to but including for example, stroke, traumatic brain injury, carotid arterial sclerotic disease, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, major depression etc.) that may influence the outcome or analysis of the scan results.
4)Contraindications to MR scanning
a)Intracranial aneurism clips (except Sugita).
b)History of intra-orbital metal fragments that have not been removed by a doctor (as confirmed by orbital X-Ray).
c)Inner ear implants.
d)Tattoos with metal containing inks or piercings that can not be removed except those, which, in the opinion of the Investigator, will not interfere with the study procedures or compromise safety.
e)History of claustrophobia or subject feels unable to lie still on their back for a period of 90 mins in the MR scanner.
f)Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire supported by plain X-Rays where appropriate.
5)Prior/Concomitant Medication
a)Use of any CNS active prescription medication within 14 days of first treatment visit.
b)Use of any OTC medication within 14 days of each treatment visit except those, which, in the opinion of the Investigator, will not interfere with the study procedures or compromise safety. Paracetamol (up to 2g) may be taken up to 24 hrs prior to each treatment visit.
c)Current use of any nicotine replacement therapy.
6)Clinical Study/Experimental Medication
a)Participation in another clinical study or receipt of an investigational drug within 3 months of the first treatment visit.
b)Previous participation in this study.
7)Allergy/Intolerance - Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
8)Substance abuse
a)History of regular alcohol consumption exceeding an average weekly intake of more than 14 units per week for females, 21 units per week for males, or an average daily intake greater than 2 units for females and 3 units for males.
b)Past history of drug abuse (i.e. meeting DSM IV [American Psychiatric Association, 1994] or ICD 10 [World Health Organisation, 1990] criteria for substance dependence), excluding nicotine, or has tested positive for urine drugs of abuse at the screening or treatment visit.
9)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).
10)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).
11)Personnel - An employee of the sponsor or the study site or members of their immediate family.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified