The End of My Addiction

physically dependent on alcohol and voluntary alcohol intake in alcohol-preferring rats (Colombo et al ., 2000, 2002). Moreover, preliminary clinical open studies have confirmed the ability of baclofen to reduce alcohol craving and intake (Addolorato et al ., 2000 b ) and alcohol withdrawal symptoms (Addolorato et al ., 2002) in alcohol-dependent patients.
    The present double-blind randomized placebo-controlled study was performed in order to determine the efficacy of short-term baclofen administration on craving for alcohol, alcohol intake and abstinence from alcohol in patients affected by alcoholism.
    Patients and Methods
    A total of 39 alcohol-dependent patients (mean age ± SD: 47.3 ± 10.5 years; mean daily drinks: 14.2 ± 7.9; mean years of addiction: 11.8 ± 4.2) were consecutively admitted to the study. Inclusion criteria were: (1) age ranging from 18 to 70 years; (2) diagnosis of current alcohol dependence according to DSM-IV criteria (American Psychiatric Association, 1994);(3) last alcohol intake reported to have taken place in the 24 h preceding observation; (4) presence of a referred family member. Exclusion criteria were the presence of: (1) severe liver, kidney, heart or lung diseases;(2) psychopathological illness undergoing treatment with psychoactive drugs, epilepsy or epileptiform convulsion; (3) addiction to drugs other than nicotine. Each patient was required to provide his/her informed consent after having received information on the characteristics, dosing rate and possible side-effects of the drug, as well as on the possibility of dropping out of the study at any time. The study protocol fully complied with the guidelines of the Ethics Committees of the Università Cattolica in Rome and of the University of Bologna, where the study was performed.
    Patients were randomized in two groups; 20 patients were treated with baclofen (mean age: 45.8 ± 10.6 years; mean daily drinks: 17.6 ± 7.5; mean years of addiction: 12.6 ± 4.8) and 19 patients with placebo (mean age: 48.8 ± 10.4 years; mean daily drinks: 10.7 ± 6.7; mean years of addiction: 11.0 ± 3.4). Patients were recruited among those contacting our Alcohol Treatment Units. Randomization was performed as follows: the 39 consecutive patients received either baclofen or placebo in a double-blind fashion. Baclofen and placebo were entrusted to a referred family member. Placebo tablets were identical in size, colour, shape and taste to baclofen tablets. Baclofen or placebo was orally administered for 4 consecutive weeks. For the first 3 days, baclofen was administered at a dose of 15 mg/day refracted in three times/day; subsequently, the daily dose of baclofen was increased to 30 mg/day refracted in three times/day. The dose prescribed was chosen on the basis of the results obtained in a previous open clinical study (Addolorato et al ., 2000 b ), and represents the minimum therapeutic dosage recommended by the drug manufacturer in order to avoid side-effects.
    In cases where symptoms of alcohol withdrawal could not have been controlled effectively by baclofen or placebo, a ‘rescue’ protocol would have been adopted, based on administration of diazepam (0.5–0.75 mg/kg body weight). However, no patients required this treatment intervention.
    All patients were strongly advised against the use of drugs capable of potentially affecting craving for alcohol. Specifically, the use of benzodiazepines, antidepressants, metadoxine, naltrexone, acamprosate,-hydroxybutyric acid (GHB), as well as alcohol-sensitizing drugs (e.g. disulfiram) was not allowed during the study period and subsequent follow-up.
    Each subject was checked as an out-patient every week for the duration of the study; at each visit, routine psychological support counselling as previously described (Addolorato et al ., 1993) was provided by the same professional staff. Craving level was evaluated by administration of the Obsessive Compulsive Drinking Scale (OCDS) at the start of the study (T0) and at each weekly out-patient visit (T1–T4). The OCDS is a validated scale consisting of two subscales which evaluate the obsessive and compulsive components of craving (Anton et al ., 1995). Abstinence from alcohol was evaluated, at each out-patient visit, on the basis of: (1) patient’s self-evaluation [reporting alcohol intake as the mean number of standard drinks consumed per day (one standard drink equal to 12 g of absolute alcohol) (Secretary of Health and Human Services, 1997)]; (2)