Healthy subjects who are smokers
Conditions
Interventions
Trade Name: Surmontil
Product Name: Surmontil
Pharmaceutical Form: Tablet
Other descriptive name: Trimipramine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
P
Sponsors
Neurocure Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, tolerability and safety of a combination of galantamine plus trimipramine in cigarette smokers who have a desire to stop smoking. The study is designed as a placebo-controlled double-blind study.;Secondary Objective: ;Primary end point(s): Main Efficacy Criteria Continuous abstinence to week 7 defined as self-report of no smoking and all study measurements of expired carbon monoxide (CO) of 10ppm (parts per million) or less. Secondary Efficacy Parameters Abstinence at each visit, time to first relapse, number of cigarettes smoked, relapse between visit 7 and visit 8, weight change. | — |
Countries
Ireland
Outcome results
None listed