A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF A COMBINATION OF GALANTAMINE (AN ACETYLCHOLINESTERASE INHIBITOR) PLUS TRIMIPRAMINE IN SMOKING CESSATION - Smoking Cessation Study

eurocure Ltd0 个研究点目标入组 109 人开始时间: 2004年7月5日最近更新: 2012年3月19日

研究概览

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•1.Healthy (by physical examination, medical history criteria) male and female volunteers aged 18-65 years (inclusive) with a current smoking history of an average of at least 15 cigarettes/day for the previous 12 months ( Note: only cigarette smoking will be addressed in this study).
•2.A negative drugs of abuse urine screen (opiates, cocaine, amphetamines, methamphetamines, tetrahydrocannabinol) at the recruitment/screening visit. A positive for a benzodiazepine is allowable if this is backed up by the subject’s medical history that they have been prescribed these drugs for an allowable condition.
•3.A normal ECG at the recruitment/screening visit.
•4.Willing and able to give informed consent.
•5.Demonstrate at entry a strong desire to quit smoking.
•6.Able to meet the study requirements and be able to meet all scheduled clinic visits (no anticipated holidays/absences).
•7.If female of child-bearing potential, a negative pregnancy test.
•8.Adequate contraception during the course (and for 4 weeks after completion of the study) for females.
•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

•1.Current use of tobacco products other than cigarettes.
•2.Current or anticipated use during the trial of any therapy (including behavioural therapy) for smoking cessation (such as nicotine replacement therapy) or Zyban.
•3.More than one volunteer per household.
•4.Current, previous or anticipated alcohol or drug abuse (including cannabis).
•5.A history of dyspepsia and/or irritable bowel disease.
•6.Histories of cardiac disease (including myocardial infarction, conduction abnormalities such as sick sinus syndrome, arrhythmias and heart block), renal impairment, liver disease, epilepsy, thyroid disease, phaeochromocytoma, angle-closure glaucoma, urinary retention or other bladder problems, porphyria, gastric ulcers (and those at risk of developing ulcers), asthma or obstructive pulmonary disease.
•7.Unstable medical conditions.
•8.A history of psychiatric disorders.
•9.Concomitant psychotropic medication (apart from benzodiazepines) and concomitant treatment with ketoconazole, erthythromycin, cimetidine, paroxetine, NSAIDs.
•10.Scheduled surgery at any time during the study.

发起方

eurocure Ltd