Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.

December 18, 2023 updated by: Institute of Liver and Biliary Sciences, India
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver & Biliary Sciences (ILBS)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. All consecutive alcohol related compensated cirrhotic patients with continued alcohol consumption despite counselling in last 4 weeks aged between 18 - 65yrs
  2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013)
  3. History of recent recidivism / relapse

Exclusion Criteria:

  1. Current HE
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Naltrexone
Naltrexone 50mg orally once daily will give for 12 weeks
Drug: Naltrexon
Naltrexone 50mg orally once daily will give for 12 weeks
Active Comparator: Baclofen
Baclofen 10mg orally thrice daily will give for 12 weeks
Drug: Baclofen
Baclofen 10mg orally thrice daily will give for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
4 weeks
To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeks
Time Frame: 24 weeks
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
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).
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
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
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILBS-ALD-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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