| September 4, 2007 |
| September 4, 2007 |
| February 2003 |
| |
| Total alcohol abstinence; cumulative abstinence duration [ Time Frame: 12 weeks ] |
| Same as current |
| No Changes Posted |
| Obsessive and Compulsive craving [ Time Frame: 12 weeks ] |
| Same as current |
| |
| Efficacy of Baclofen in the Treatment of Alcohol Addiction |
| Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study |
Intervention to achieve alcohol abstinence represents the most effective treatment for alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of anti-craving drugs in these patients because of the concern that these medications might worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have been reported in treated patients. The present study investigates the efficacy and safety of baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients. |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Liver Cirrhosis, Alcoholic |
- Drug: Baclofen
- Drug: placebo
|
- Placebo Comparator: A total of 42 alcoholic patients with liver cirrhosis treated with placebo
- Active Comparator: a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
|
- Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8.
- Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet. 2007 Dec 8;370(9603):1915-22.
|
| |
| Completed |
| 86 |
| November 2006 |
|
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
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00525252 |
|
| Bacl001 |
| Catholic University of the Sacred Heart |
|
| Principal Investigator: |
Giovanni Addolorato, M.D. |
Catholic University of Rome |
|
|
| Catholic University of the Sacred Heart |
| September 2007 |