Health Condition 1: F102- Alcohol dependence Health Condition 2: null- diagnosis of alcohol dependence
Conditions
Interventions
Intervention1: Baclofen GRS (40mg and 60mg): One capsule to be taken once daily with major meal of the day in the morning or evening for 12 weeks.
Control Intervention1: Placebo GRS (40mg and 60mg): O
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with age 21 to 75-years inclusive, meeting DSM-IV-TRï?ª criteria for current alcohol dependence (per appendix I: M.I.N.I. for alcohol abuse and dependence) who are detoxified before enrollment in study. (subjects who have completed detoxification treatment can be enrolled) 2. Presence of referred family member able to assist with drug administration and monitoring. 3. Express a desire to achieve abstinence or to greatly reduce alcohol consumption. 4. Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test. 5. Willing to participate and give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Requiring inpatient detoxification and treatment with drugs other than single agent baclofen. 2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times the upper limit of normal. 3. Bilirubin more than the upper limit of normal. 4. Current treatment with naltrexone, disulfiram, acamprosate, topiramate, ondansetron: subjects can be included after appropriate washout. 5. Positive urine screen on amphetamines/ barbiturates/ benzodiazepines/ cocaine/ opiates. 6. 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). 7. Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, or severe depression; suicidal ideation; substance use disorder other than alcohol or nicotine dependence. Subjects with ADHD/ ASPD may be included at discretion of the investigator. 8. Current episode marked by/ current presentation of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens. 9. Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics. Subjects who have been taking benzodiazepines for alcohol detoxification will be required to have a washout period of approximately 5 days from those medications before being randomized. 10. Participation in another clinical trial within the preceding 60 days of study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable: 1. Abstinence rate 2. Relapse rate Timepoint: Week 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to relapse 2. Time to first lapse 3. Number of abstinent days 4. Number of drinks per drinking day 5. Number of heavy drinking days [(HDD) 6. Liver biomarkers 7. Alcohol dependence severity 8. Extent of craving for alcohol 9. Extent of craving for alcohol 10. Compliance to treatment: 11. Compliance to study: 12. Investigatorâ??s global impression of change and subjectâ??s global impression of change. Timepoint: Week 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12;Safety variables 1. Physical examination 2. Vital signs 3. Treatment emergent adverse events. 4. Clinically significant changes in laboratory parameters. Timepoint: Week 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed