Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.
NCT ID: NCT06175507
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2023-12-25
2025-03-31
Brief Summary
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Detailed Description
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• To compare the efficacy of Naltrexone Vs Baclofen in achieving and maintaining 12-week abstinence in patients with alcohol associated liver cirrhosis with continued alcohol use
Primary objective:
* The comparison in the proportion of patients achieving and maintaining alcohol abstinence between Naltrexone and Baclofen in alcohol associated liver cirrhosis patients with continued alcohol intake at 12 weeks
* Secondary objectives:
* To evaluate drinking pattern before and after 4 week on Naltrexone without liver related adverse effects compared to baclofen
* To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeks
* To evaluate difference in craving measures between groups at 4, 8,12 and 24 weeks
* To evaluate difference in alcohol free days between groups at 4, 8,12 and 24 weeks
* To evaluate proportion of patients developing lapse and relapse in both the group at 4,8,12 and 24 weeks
* To evaluate the progression of liver disease in both group
Methodology:
* Study population: All patients aged ≥ 18 years and ≤ 65 years admitted in Institute of Liver and Biliary Sciences, New Delhi with alcohol dependence in compensated liver disease and are giving written consent for participation in the study.
* Study design - Single center, Open label, Randomized controlled trial
* Study period - 1.5 years after IEC approval.
* Sample size - We are enrolling 110 patients, with 55 in each arm.
* Intervention -
* Naltrexon group: Naltrexone 50mg orally once daily will give for 12 weeks.
* Baclofen group: Baclofen 10mg orally thrice daily will give for 12 weeks.
* Monitoring and assessment:
* Follow up- weekly in first month and 2nd weekly there after
* LFT (AST, ALT, GGT, Albumin, INR), CBC with MCV, KFT at every visit At every visit
* Review of drinking and assessment of abstinence, lapses and relapses from alcohol
* Overall functioning, quality of life, social relationships
* Difficulties with treatment adherence (pill counts)
* Adverse effects - drug/ withdrawal related
* Psychological support and counselling at every visit by psychiatrist
* Statistical Analysis: The data will be represented as mean±SD. The categorical data will be analysed using Chi-square test. The continuous data will be analysed by student T test, or Mann-Whitney test, whichever is applicable. Besides this, Cox regression will be applied to analyse the variables. For all tests, p≤ 0.05 will be considered statistically significant
* Adverse effects
* Headaches, nausea, dyspepsia, anorexia, anxiety and sedation.
* Stopping rule
* Worsening of liver disease severity to CTP \>9
* AST or ALT \> 5 times ULN
* Withdrawal of consent
* New onset decompensation
* Worsening of Bilirubin \> 5 mg/dl
Expected outcome of the project:
\- To achieve abstinence in both the group without affecting the liver.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Naltrexone
Naltrexone 50mg orally once daily will give for 12 weeks
Naltrexon
Naltrexone 50mg orally once daily will give for 12 weeks
Baclofen
Baclofen 10mg orally thrice daily will give for 12 weeks
Baclofen
Baclofen 10mg orally thrice daily will give for 12 weeks
Interventions
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Naltrexon
Naltrexone 50mg orally once daily will give for 12 weeks
Baclofen
Baclofen 10mg orally thrice daily will give for 12 weeks
Eligibility Criteria
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Inclusion Criteria
2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013)
3. History of recent recidivism / relapse
Exclusion Criteria
2. Total Bilirubin \> 5 mg/dl
3. Recent bleed
4. Treatment with corticosteroids within the past 60 days
5. Unwilling to participate
6. Dependence on any other substance (except Nicotine)
7. Psychotic disorder requiring treatment
18 Years
65 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Dr Ravi Nishad, MD
Role: primary
Other Identifiers
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ILBS-ALD-02
Identifier Type: -
Identifier Source: org_study_id