Last reviewed · How we verify
NCT06175507
Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.
NA trial testing Naltrexon in Alcohol Liver Disease in 110 participants. Status unknown.
31 March 2025
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 25 December 2023 |
| Primary completion | 31 March 2025 |
| Estimated completion | 31 March 2025 |
| Sites | 1 location across India |
Drugs / interventions tested
Conditions studied
- Alcohol Liver Disease — all drugs for Alcohol Liver Disease →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 65, any sex, with Alcohol Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
MetALD: Does it require a different therapeutic option?
Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935
Verify or expand the search:
- PubMed search for NCT06175507
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Alcohol Liver Disease
Currently open trials in the same condition.
- NCT07009860 — RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated · Phase 2 · recruiting
- NCT06304467 — CM for Patients With ALD After Liver Transplant · NA · active not recruiting
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
- NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06175507 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 19 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06175507.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing