Liver CirrhosisNCT04391764
Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.
A study testing Naltrexone in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The aim of the study is to study the safety and tolerability of Naltrexone in patients with Alcohol liver disease over a 12 week duration without liver related side effects. The project will be conducted at ILBS from March 2020 to February 2021. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 6 Dec 2020to 31 Oct 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All consecutive alcohol dependent cirrhotic aged between 18-60 yrs.
- Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).
Who cannot join
- Current Hepatic Encephalopathy
- Total Bilirubin > 3 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/Suicidal tendency.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis- A Double Blind Randomized Controlled Trial.
The aim of the study is to study the safety and tolerability of Naltrexone in patients with Alcohol liver disease over a 12 week duration without liver related side effects. The project will be conducted at ILBS from March 2020 to February 2021. The concept is to estimate the usage of naltrexone and establish its safety in cirrhotics and study its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.
All ALD patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. In case of any reactions, the drug will be stopped as per the study stopping rule.
After following the inclusion and exclusion criteria, ALD patients will be recruited into the study. It's a double blind RCT, hence both the patient and the investigator will be blinded and the drug will be issued by the trial co-ordinator after taking informed written consent and explaining the side effects. Naltrexone at a dose of 50 mg per day and placebo are included in the tablets. Placebo tablets will be identical in size, colour, shape, and taste. Naltrexone tablets will be entrusted to a family member to administer every dose and monitor for side effects.
- Conditions
- Liver Cirrhosis
- Being tested
- Naltrexone, Placebo oral tablet
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Naltrexone at a dose of 50 mg per day
Placebo oral tabletDrug
Placebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | Naltrexone at a dose of 50 mg per day. Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | Placebo tablets will be identical in size, colour, shape, and taste and will be given in a similar manner. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups
Measured: 12 weeks
Secondary outcomes (8)
Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo
Measured: 12 weeks
Proportion of patients maintaining abstinence from alcohol at 6 months in both groups
Measured: 6 months
Proportion of patients maintaining abstinence from alcohol at 12 months in both groups
Measured: 12 months
difference in craving measures between groups at 4 weeks in both groups
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Measured: 4 weeks
difference in craving measures between both groups at 8 weeks.
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Measured: 8 weeks
difference in craving measures between both groups at 12 weeks.
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Measured: 12 weeks
difference in craving measures between both groups at 6 months.
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Measured: 6 months
difference in craving measures between both groups at 12 months.
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start6 Dec 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
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
- NCT04391764
- Sponsor's protocol ID
- ILBS-Cirrhosis-28
- Status last verified
- Mar 2023
- First submitted
- 8 May 2020
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alla M, Varshney M, Bhardwaj A, Kumar G, Shasthry SM, Sarin SK. Naltrexone Is Superior to Placebo for Abstinence and Craving Reduction in Alcohol-Associated Cirrhosis: NAL-CI Trial. Liver Int. 2026 Sep;46(9):e70845. doi: 10.1111/liv.70845.
PubMed 42615276
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis- A Double Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04391764
- Acronym / sponsor ID
- ILBS-Cirrhosis-28
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 18 May 2020 (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.
The aim of the study is to study the safety and tolerability of Naltrexone in patients with Alcohol liver disease over a 12 week duration without liver related side effects. The project will be conducted at ILBS from March 2020 to February 2021. The concept is to estimate the usage of naltrexone and establish its safety in cirrhotics and study its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.
All ALD patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. In case of any reactions, the drug will be stopped as per the study stopping rule.
After following the inclusion and exclusion criteria, ALD patients will be recruited into the study. It's a double blind RCT, hence both the patient and the investigator will be blinded and the drug will be issued by the trial co-ordinator after taking informed written consent and explaining the side effects. Naltrexone at a dose of 50 mg per day and placebo are included in the tablets. Placebo tablets will be identical in size, colour, shape, and taste. Naltrexone tablets will be entrusted to a family member to administer every dose and monitor for side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: NaltrexoneNaltrexone at a dose of 50 mg per day. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo tablets will be identical in size, colour, shape, and taste and will be given in a similar manner. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All consecutive alcohol dependent cirrhotic aged between 18-60 yrs.
- Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).
Key exclusion criteria (7 listed)
- Current Hepatic Encephalopathy
- Total Bilirubin > 3 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 |
|---|---|---|
| NaltrexoneNaltrexone at a dose of 50 mg per day | Drug | Naltrexone |
| Placebo oral tabletPlacebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner. | Drug | Placebo |
Primary outcome
Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups
Time frame: 12 weeks
8 secondary outcomes
Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo
Time frame: 12 weeks
Proportion of patients maintaining abstinence from alcohol at 6 months in both groups
Time frame: 6 months
Proportion of patients maintaining abstinence from alcohol at 12 months in both groups
Time frame: 12 months
difference in craving measures between groups at 4 weeks in both groups
Time frame: 4 weeks
difference in craving measures between both groups at 8 weeks.
Time frame: 8 weeks
difference in craving measures between both groups at 12 weeks.
Time frame: 12 weeks
difference in craving measures between both groups at 6 months.
Time frame: 6 months
difference in craving measures between both groups at 12 months.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 42615276Alla M, Varshney M, Bhardwaj A, Kumar G, Shasthry SM, Sarin SK. Naltrexone Is Superior to Placebo for Abstinence and Craving Reduction in Alcohol-Associated Cirrhosis: NAL-CI Trial. Liver Int. 2026 Sep;46(9):e70845. doi: 10.1111/liv.70845.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone in people with Liver Cirrhosis, 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 2 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: finished, as of the sponsor's last update on 28 Mar 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391764, which also lists 1 linked publication.
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 28 Mar 2023.