Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Brief Summary: To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.


Options:
A: Inclusion Criteria:

* age ranging from 18 to 75 years
* diagnosis of alcohol dependence according to DSM IV criteria
* diagnosis of liver cirrhosis
* alcohol intake of at least 2 heavy drinking days (men \> 5 drinks/days; women \> 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment
* presence of a referred family member

Exclusion Criteria:

* severe heart or lung disease
* kidney alterations and/or hepato-renal syndrome
* tumours, including hepatocellular carcinoma
* metabolic diseases, including diabetes
* clinical signs of hepatic encephalopathy
* patients treated with interferon or corticosteroids within the last 60 days
* psychopathological illness undergoing treatment with psychoactive drugs
* epilepsy or epileptiform convulsions
* addiction to drugs other than nicotine
B: Inclusion Criteria:

* Problem drinking in the last 30 days

Exclusion Criteria:

* Prolonged abstinence
* Serious medical problems
C: Inclusion Criteria:

* Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria
* An alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol)
* Last alcohol consumption within 7-21 days before randomisation
* Sufficient German language capabilities

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinical significant medical conditions or observed abnormalities
* Psychiatric illness undergoing treatment with psychoactive drugs
* Epilepsy or epileptiform convulsions
* Addiction to drugs other than nicotine
D: Inclusion Criteria:

* ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for \>10 years.
* Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Willingness to give written informed consent
* Abstinence from alcohol for between 3 and 21 days
* Resolution of any clinically evident alcohol withdrawal (CIWA-AR)

Exclusion Criteria:

* Active major psychological disorder associated with psychosis or significant suicide risk
* Pregnancy or lactation
* Concurrent use of any psychotropic medication other than antidepressants
* Substance use other than nicotine if unstable
* Clinical evidence of persisting hepatic encephalopathy
* Pending incarceration
* Lack of stable housing
* Active peptic ulcers
* Unstable diabetes mellitus

Answer: D