Varenicline for Alcohol Dependence

Johannes Gutenberg University (JGU)

Status and phase

Unknown

Phase 2

Conditions

Alcohol Dependence

Treatments

Drug: Varenicline

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01071187

2009-08-17

2009-015537-67 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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