E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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] - Psychological processes [F02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001594 |
E.1.2 | Term | Alcohol dependence syndrome |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
To analyse the efficacy and safety of varenicline (Champix) versus placebo for relapse prevention in post-acute treatment (7-21 after last drink) in alcohol dependent patients.
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E.2.2 | Secondary objectives of the trial |
Investigation of drinking-quantity reducing properties of varenicline in a group of alcohol dependent patients, as measured by
- Amount of alcoholic drinks per drinking day
- Percentage of heavy drinking days (more than six standard drinks for a man and four standard drinks for a woman)
Safety and tolerability of varenicline in post-acute treatment in alcohol dependent patients
Investigation of alcohol craving with the OCDS and VAS
Measurement the overall clinical impression (CGI)
Measurement of quality of life (SF-12 questionnaire)
Measurement of the frequency of smoking (number of cigarettes per day and percentage of abstinent days)
Measurement of nicotine dependence severity (Fagerstrom Index for Nicotine Dependence - FTND)
Measurement of severity of depression (Beck Depression Inventory - BDI)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Alcohol dependent as defined by the criteria of Diagnostic and Statistical Manual of mental disorders (DSM IV)
Male and female in- or outpatients
Current smoker
Aged 18 to 65 years
Last consumption of alcohol 7-21 days before randomisation
Detoxified and free of withdrawal symptoms at randomisation
Sufficient knowledge of German language
Able to follow verbal and written instructions
Able to provide written informed consent |
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E.4 | Principal exclusion criteria |
Delirium after current withdrawal, alcohol-induced dementia, Wernicke-Korsakoff syndrome
Severe renal insufficiency
Severe liver insufficiency
Involutary Detoxification
Female patients pregnant, breast feeding or fo child bearing age and not protected by medically acceptable contraception
Patients with clinically relevant concomitant psychiatric discorders (including a major depressive episode, psychotic discorders, antisocial personality disorder according to DSM IV in medial history)
Patients with an addiction or substance abuse of other addiction-inducing substances (except nicotine or cannabis) within the last 24 months before inclusion in the trial
Patient having a current suicide risk with a score > 6 at the suicidality item C of the M.I.N.I. international neuropsychiatric interview (MINI)
Patients with any clinically significant acute or chronic progressive neurological, gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
Patients with a current relevant depression (Hamilton Rating Scale for Depression (German version) values ≥ 9 or Beck Depression Inventory (German version) values ≥ 12)
Patients with a history of cancer within the last five years
Patients with a history of stroke or myocardial infarction within the last 6 months before screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent of days abstinent from any alcohol (TLFB) during 12-weeks treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 12 weeks of treatment |
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E.5.2 | Secondary end point(s) |
• Zeit bis zum ersten alkoholischen Getränk/ Trinkzwischenfall (in Tagen), erfasst mittels Time-Line-Follow-Back Interview
• Anteil dauerhaft abstinenter Patienten während der Behandlung
(in Prozent der Anzahl der Patienten)
• Anzahl der Standarddrinks pro Trinktag, erfasst mittels Time-Line-Follow-Back Interview
• Zeit bis zum ersten schweren Trinken (in Tagen), erfasst mittels Time-Line-Follow-Back Interview
• Anzahl der Tage mit schwerem Trinken (in Prozent der Behandlungstage), erfasst mittels Time-Line-Follow-Back Interview
• Veränderungen der Gamma-Glutamyl-Transferase (ץ-GT)
• Unerwünschte Ereignisse
• Compliance der Patienten
• Alkohol Craving gemessen mit der Obsessive Compulsive Drinking Scale (OCDS) und einer Visuellen Analog Skala des Cravings (VAS)
• Schweregrad der Alkoholabhängigkeit gemessen mit dem EuropASI (siehe 6.1.1.9)
• Globale Zustandsveränderung gemessen mit der
Clinical Global Impression of Change (CGI)
• Lebensqualität (SF-12 Fragebogen)
• Intensität des Rauchens (Anzahl der Zigaretten/Tag und CO-Messung)
• Die Anzahl der nikotinabstinenten Behandlungstage (in Prozent der Behandlungstage)
• Schwere der Nikotinabhängigkeit gemessen mit dem Fagerstrom Test der Nikotinabhängigkeit (FTND)
• Intensität der depressiven Beschwerden
[gemessen mit dem Beck Depressions Inventar (BDI)]
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 12 weeks of treatment |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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end of trial ist last visit of the last patient |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |