treatment of dependence in alcohol addiction MedDRA version: 9.1 Level: LLT Classification code 10001639 Term: Alcoholism
Conditions
Interventions
Trade Name: LIORESAL*50CPR 10MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Baclofen
CAS Number: 1134-47-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women between the ages of 18 and 60 meeting DSM-IV criteria for current alcohol dependence. 2. Must have had 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 screening. 3. Able to understand and sign written informed consent. 4. Must be willing to refrain from drinking for three days prior to randomization day. 5. Express a desire to achieve abstinence or to greatly reduce alcohol consumption. 6. Must have a stable residence and be able to identify an individual who could locate subject if needed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., cirrhosis, kidney impairment, unstable hypertension, hypotension, diabetes mellitus, seizure disorder). 2. Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, or severe depression; suicidal ideation; substance use disorder other than alcohol or nicotine dependence or cannabis abuse. 3. History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens. 4. Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics. However, subjects who have been on stable doses of the antidepressants fluoxetine, sertraline, paroxetine, citalopram, ecitalapram, trazodone or venlafaxine for two months will be eligible. Subjects who have been taking benzodiazepines for alcohol detoxification will be required to have a washout period of at least five half-lives (approximately 5 days) from those medications before being randomized. 5. Concurrent use of anticonvulsants, insulin, or oral hypoglycemics. 6. AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or creatinine > ULN. 7. Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of cannabis dependence. 8. Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal). 9. Women who are breastfeeding. 10. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence. 11. Participation in any clinical trial within the last 60 days. 12. Court-mandated participation in alcohol treatment or pending incarceration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to estimate efficacy and tolerability of baclofen in reducing alcohol intake and craving in alcohol dependent patients.;Secondary Objective: to evaluate the effects on the anxiety and depression and on the hematological markers of alcohol addiction.;Primary end point(s): Significant reduction of alcohol consumption and craving of the patients. | — |
Countries
Italy
Outcome results
None listed