| CTRI Number |
CTRI/2024/06/069491 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To examine how well Baclofen and Naltrexone work as medications in individuals with alcohol addiction and withdrawal symptoms. |
|
Scientific Title of Study
|
To study the efficacy and safety of Baclofen versus Baclofen and Naltrexone as Anticraving agents in patients of Alcohol Dependence with Alcoholic Liver Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul |
| Designation |
Junior Resident Department of Psychiatry, Government Medical College Rajindra Hospital Patiala |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Department of Psychiatry
Government Medical College Rajindra Hospital Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9646581573 |
| Fax |
|
| Email |
rahulbangar30@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnish Raj |
| Designation |
Professor and Head of Department |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Department of Psychiatry
Government Medical College Rajindra Hospital Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9463323686 |
| Fax |
|
| Email |
profheadpsy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Garg |
| Designation |
Professor Department of Psychiatry Government Medical College Rajindra Hospital Patiala |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Department of Psychiatry
Government Medical College Rajindra Hospital Patiala Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9463312682 |
| Fax |
|
| Email |
jrpsychiatry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Rajindra Hospital Patiala Punjab India 147001 |
|
|
Primary Sponsor
|
| Name |
Rahul |
| Address |
Department of Psychiatry, Government Medical College, Rajindra Hospital Patial, Punjab 147001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rahul |
Government Medical College Rajindra Hospital Patiala |
Room No 2 Department of Psychiatry
Patiala
PUNJAB |
9646581573
rahulbangar30@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee IEC Government Medical College Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TO STUDY THE EFFICACY AND SAFETY OF BACLOFEN VERSUS BACLOFEN AND NALTREXONE AS ANTICRAVING AGENTS IN PATIENTS OF ALCOHOL DEPENDENCE WITH ALCOHOLIC LIVER DISEASE |
In another group drug is Baclofen, Dose of Baclofen 20mg to 60 mg, route orally, duration 6 months. |
| Intervention |
TO STUDY THE EFFICACY AND SAFETY OF BACLOFEN VERSUS BACLOFEN AND NALTREXONE AS ANTICRAVING AGENTS IN PATIENTS OF ALCOHOL DEPENDENCE WITH ALCOHOLIC LIVER DISEASE |
In one group drug is combination of Baclofen and Naltrexone, dose of Baclofen 20mg to 60mg,
Dose of Naltrexone 50mg,
Route orally,
Duration 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 18 to 60 years
2. Alcohol Dependence according to the DSM-5-TR
3.JELLINEK’s alcoholic type gamma, delta and epsilon ε type
4.Adequate cognition and language skills to give valid consent and to complete research interviews
5.Written informed consent
6. Written informed consent for naltrexone, if applicable
|
|
| ExclusionCriteria |
| Details |
1.Active major psychiatric disorder except alcohol dependence
2.Pregnancy or lactating women
3.Dependence on other substances except alcohol and nicotine
4. Opioid abuse, opioid dependence or opioid agonist treatment, or likely need for opioid treatment
5. Any evidence of alcoholic cirrhosis or advanced fibrosis, either clinically or through relevant investigations including fibroscan
6.Lack of stable housing or contact phone number
7.Previous hypersensitivity to baclofen or naltrexone
8.Any pharmacotherapy related to alcohol dependence or ALD before enrolment
9.Contra-indications for baclofen treatment were uncontrolled epilepsy, patent hepatic encephalopathy, and renal failure
10. Contra-indication for naltrexone – Acute/ Fulminant liver failure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy –
1.Abstinence – Number of non drinking days
2.Time to lapse
3.Time to relapse (if present)
1-3 Assessed by TLFB scale
4.Craving Assessed by OCDS and VASC scale
5. Decreased CIWA-Ar score after lapse / relapse
Safety –
Hepatic impairment assessed by serial LFTs |
1 month
2 months
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prognostic scoring of Alcoholic Liver Disease by Maddrey Discriminant function (MDf)
Decreased alcohol related hospitalization
Adverse events reported as per CDSCO Central Drugs Standard Control Organization reporting form |
Follow up assessment for secondary outcomes will be done at baseline 1 month 2 months 3 months 6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
still not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Alcohol dependence (AD) is a global health problem. There are several pathways involved in the development and maintenance of alcohol dependence including dopaminergic, glutamergic and GABAergic pathways. Treatment of AD consists of two phases: detoxification and rehabilitation. Anticraving medications for Alcohol Use Disorder (AUD) include, naltrexone, acamprosate, baclofen. The role of anticraving agents in AD with alcoholic liver disease has been studied less. Therefore, the current study is taken to explore the efficacy and safety of baclofen versus baclofen and naltrexone combination in patients of AD with alcoholic liver disease. It will be a hospital based, interventional, comparative and prospective follow-up, single-blind randomized trial. Screening for AD will be done using AUDIT scale. A total of 150 patients of AD with Alcoholic Liver Disease (ALD) diagnosed as per DSM-5 tr and ACG guidelines, respectively. The socio-demographic and clinical data will be recorded. Participants will be assigned into three groups by simple random sampling comprising of 50 patients each. Group A (Baclofen), Group B (Baclofen and Naltrexone) combination and placebo (Control) group. Primary outcome will include efficacy assessment by TLBF scale, OCDS, VASC, CIWA-Ar and safety assessment by serial LFTs. Secondary outcome will be assessed by prognostic scoring on Maddrey Discriminant function (MDf). The observations will be done at the time of admission and follow-ups after 1 month, 2 months, 3 months and 6 months, respectively. Data will be analysed by the relevant tests wherever applicable at statistically significant p value ≤ 0.05. |