Alcohol Liver DiseaseNCT06175507
Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.
A study testing Naltrexon and Baclofen in people with Alcohol Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve survival. Baclofen is GABA-B receptor agonist and it is safe in cirrhotic patient for alcohol abstinence i.e. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Liver Disease
- What is being tested?
- Naltrexon and Baclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- 25 Dec 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive alcohol related compensated cirrhotic patients with continued alcohol consumption despite counselling in last 4 weeks aged between 18 - 65yrs
- Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013)
- History of recent recidivism / relapse
Who cannot join
- Current HE
- Total Bilirubin > 5 mg/dl
- Recent bleed
- Treatment with corticosteroids within the past 60 days
- Unwilling to participate
- Dependence on any other substance (except Nicotine)
- Psychotic disorder requiring treatment
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Ravi Nishad, MD, 01146300000, ravinishad.422@gmail.com
About this study
ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve survival. Baclofen is GABA-B receptor agonist and it is safe in cirrhotic patient for alcohol abstinence i.e. already proven and naltrexone is Delta and k-opioid receptor antagonist and it is safe in cirrhotic for alcohol abstinence i.e, proven in ILBS.
Read the detailed description
Aim and Objective:
- 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
- Alcohol Liver Disease
- Being tested
- Naltrexon, Baclofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexonDrug
Naltrexone 50mg orally once daily will give for 12 weeks
BaclofenDrug
Baclofen 10mg orally thrice daily will give for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | Naltrexone 50mg orally once daily will give for 12 weeks Receives: Drug: Naltrexon |
| Baclofen | Active comparator | Baclofen 10mg orally thrice daily will give for 12 weeks Receives: Drug: Baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (6)
To evaluate abstinence rate by OCDS score in both the group (OCDS- Obsessive compulsive drinking scale 0-40, Higher total score indicate more obsessive thoughts or compulsive behaviour regarding alcohol use)
Measured: 4 weeks
To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeks
Measured: 24 weeks
To evaluate difference in craving measures between groups at 4,8,12 and 24 weeks.
Craving measures will be assessed based on pre existing structured and validated questionnaires. (Visual analogue scale (VAS) score, score 0-10, 10 suggestive of maximum craving).
Measured: 4, 8,12 and 24 weeks
To evaluate difference in alcohol free days between groups at 4, 8,12 and 24 weeks
Measured: 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
Measured: 4,8,12 and 24 weeks
To evaluate the progression of liver disease in both group at 24weeks by measuring Child pugh score.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start25 Dec 2023 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175507
- Sponsor's protocol ID
- ILBS-ALD-02
- Status last verified
- Oct 2023
- First submitted
- 16 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.
- ClinicalTrials.gov ID
- NCT06175507
- Acronym / sponsor ID
- ILBS-ALD-02
- Conditions
- Alcohol Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 25 Dec 2023 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve survival. Baclofen is GABA-B receptor agonist and it is safe in cirrhotic patient for alcohol abstinence i.e. already proven and naltrexone is Delta and k-opioid receptor antagonist and it is safe in cirrhotic for alcohol abstinence i.e, proven in ILBS.
Detailed description
Aim and Objective:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: NaltrexonNaltrexone 50mg orally once daily will give for 12 weeks |
| Baclofen | Active comparator | Drug: BaclofenBaclofen 10mg orally thrice daily will give for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All consecutive alcohol related compensated cirrhotic patients with continued alcohol consumption despite counselling in last 4 weeks aged between 18 - 65yrs
- Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013)
- History of recent recidivism / relapse
Key exclusion criteria (7 listed)
- Current HE
- Total Bilirubin > 5 mg/dl
- Recent bleed
- Treatment with corticosteroids within the past 60 days
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexonNaltrexone 50mg orally once daily will give for 12 weeks | Drug | Naltrexone |
| BaclofenBaclofen 10mg orally thrice daily will give for 12 weeks | Drug | Baclofen |
Primary outcome
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
Time frame: 12 weeks
6 secondary outcomes
To evaluate abstinence rate by OCDS score in both the group (OCDS- Obsessive compulsive drinking scale 0-40, Higher total score indicate more obsessive thoughts or compulsive behaviour regarding alcohol use)
Time frame: 4 weeks
To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeks
Time frame: 24 weeks
To evaluate difference in craving measures between groups at 4,8,12 and 24 weeks.
Time frame: 4, 8,12 and 24 weeks
To evaluate difference in alcohol free days between groups at 4, 8,12 and 24 weeks
Time frame: 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
Time frame: 4,8,12 and 24 weeks
To evaluate the progression of liver disease in both group at 24weeks by measuring Child pugh score.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexon and Baclofen in people with Alcohol Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ravi Nishad, MD (01146300000, ravinishad.422@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.