Varenicline for Alcohol Dependence

Study Overview
=================
Brief Summary
-----------------
The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study.

Official Title
-----------------
Investigation of the Efficacy and Safety of Varenicline in the Postacute Treatment of Alcohol Dependence - a Prospective, Double-blind, Placebo-controlled, Randomised Phase-II Study

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: Varenicline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of alcohol dependence according to DSM IV inpatient or outpatient last alcohol consumption within 7-21 days before randomisation subjects must have gone through a detoxification program and must be free of withdrawal symptoms at randomisation diagnosis of nicotine dependence according to DSM IV sufficient knowledge of the german language subject is able to follow verbal and written instructions subject is enabled to consent ability of subject to understand character and individual consequences of the clinical trial signed and dated informed consent of the subject must bei available before start of any specific trial procedures subject must have a clearly stated desire to stay abstinent women who are postmenopausal for more than two years or women with childbearing potential who practicing two years can participate in the study Exclusion Criteria: alcohol withdrawal delirium during last alcohol detoxification alcohol induced dementia severe renal insufficiency detoxification against subject's will women who are pregnant or breastfeeding or planning to become pregnant during the trial women with childbearing potential who not practicing a medically accepted contraception during the trial subjects with a known psychiatric disorder requiring treatment including a major depressive disorder, a substance dependence or abuse (besides nicotine, alcohol and cannabis)a psychosis or a dissocial personality disorder according to DSM-IV elevated suicide risk, defined as one positive question in the suicide section of the Mini-International Neuropsychiatric Interview (M.I.N.I.) subjects with acute depression, defined as a HAMD17 (german version) sum score > 9 or a BDI (german version) sum score > 12 clinically relevant acute or chronic progressive neurologic, gastrointestinel, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease severe infection, a alcohol-induced hepatitis or a uncontrolled arterial hypertension use of any medication that can effect on alcohol consumption within 14 days of study initiation including antidepressants, antipsychotics, anticonvulsives, benzodiazepines (besides given in the contect of the detoxification program, anticraving drugs as naltrexone, acamprosate and disulfiram and nicotine substitutes subjects with following lab parameters: AST upper fivehold normal limit, PTT < 50%, leucocytes <2/nl, haemoglobin < 9g/dl, thrombocytes < 80/nl, creatinine > 1,5mg/dl and creatinine clearance < 30ml/min history of cancer in 5 last years known allergy against ingredient of study drug history of myocardial infarction or stroke participation in a clinical trial during last 90 days prior to screening clinically relevant visual disturbance or ear disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline<br>Treatment with varenicline with 0,5mg daily on day 1-3, 1mg daily on day 4-7 and 2mg daily on day 8-84. | Drug: Varenicline<br>* Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview |  | 12 weeks | 
| Proportion of abstinent patients during the study, percentage of all patients |  | 12 weeks | 
| Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview. |  | 12 weeks | 
| Time in days to first heavy drinking, assessed by the time-line-follow-back-interview. |  | 12 weeks | 
| Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview. |  | 12 weeks | 
| Changes in gamma-glutamyl transpeptidase levels |  | 12 weeks | 
| Occurrence of adverse events |  | 12 weeks | 
| Compliance of the subjects |  | 12 weeks | 
| alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS) |  | 12 weeks | 
| Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI) |  | 12 weeks | 
| Absolute change in the Clinical Global Impression of Change (CGI) |  | 12 weeks | 
| Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12) |  | 12 weeks | 
| Number of cigarettes per day |  | 12 weeks | 
| Number of nicotine abstinent days, percentage of the treatment days |  | 12 weeks | 
| Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence |  | 12 weeks | 
| Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol dependence, addiction, alcohol, relapse prevention