E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
nicotine addiction |
nicotine verslaving |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
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 |
Our study will test whether disrupting reconsolidation by the noradrenergic beta-blocker propranolol (i.e., 40mg) provides long-term relief from nicotine addiction. |
In deze studie wordt onderzocht of het verstoren van het reconsolidatie-proces middels toediening van de noradrenerge beta-blokker propranolol (i.e., 40mg) het rookgedrag doorbreekt. |
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E.2.2 | Secondary objectives of the trial |
not applicable |
niet van toepassing |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- aged between 18 and 65 years; - smoking 10 or more cigarettes per day for at least 12 months; - written approval of participant's own general practitioner for participation. |
- leeftijd tussen de 18 en 65 jaar; - roken van meer dan 10 sigaretten per dag voor ten minste 12 maanden; - schriftelijke toestemming van eigen huisarts voor deelname onderzoek. |
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E.4 | Principal exclusion criteria |
- cardiovasculaire diseases or irregular heartbeat; - hypotension or hypertension; - pregnancy or breastfeeding; - epilepsy; - current state of asthma or COPD, which necessitates medication use. |
- cardiovasculaire ziekten of onregelmatige hartslag; - lage of hoge bloeddruk; - zwangerschap of borstvoeding; - epilepsie; - astma of COPD, waarvoor medicatie. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quit smoking: not a single puff, as assessed by a daily online smoking diary. |
Gestopt met roken: geen enkele trek, dagelijks gemeten met een online rookdagboek. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3-months post-treatment. |
3 maanden na behandeling. |
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E.5.2 | Secondary end point(s) |
- breath monoxide assessment: < 10ppm CO; - urine cotinine levels: < 10 ng-mL; - ten-item questionnaire on smoking urges (QSU-brief): craving; - mood and physical symptom scale (MPSS): withdrawal symptoms. |
- koolmonoxide ademtest: < 10ppm CO; - urine cotinine levels: < 10 ng-mL; - ten-item questionnaire on smoking urges (QSU-brief): craving; - mood and physical symptom scale (MPSS): ontwenningsverschijnselen. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
7-days and 3-months post-treatment. |
7 dagen en 3 maanden na behandeling. |
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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 | Yes |
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 | No |
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 | Yes |
E.8.1.6 | Cross over | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |