Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2024/06/069491
CTRI/2024/06/069491
Recruiting
Phase 3

To study the efficacy and safety of Baclofen versus Baclofen and Naltrexone as Anticraving agents in patients of Alcohol Dependence with Alcoholic Liver Disease - NI

Rahul0 sites0 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: F102- Alcohol dependence

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: F102- Alcohol dependence
Sponsor
Rahul
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Rahul

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 18 to 60 years
  • •2\. Alcohol Dependence according to the DSM\-5\-TR
  • •3\.JELLINEK’s alcoholic type gamma, delta and epsilon e 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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Not Yet Recruiting
Phase 4
A study to compare whether oral baclofen or oral tizanidine is better in patients presenting with tightness of the upper limb after stroke.Health Condition 1: G811- Spastic hemiplegia
CTRI/2024/03/064651Jalpaiguri Government Medical College and Hospital
Active, Not Recruiting
N/A
Efficacy evaluation of oral baclofen treatment versus intrathecal baclofen in children with dystonic cerebral palsy - Oral/intrathecal therapy in children with dystoniaDystonic or spastic dystonic cerebral palsyMedDRA version: 9.1Level: SOCClassification code 10029205MedDRA version: 9.1Level: PTClassification code 10008129MedDRA version: 9.1Level: LLTClassification code 10021740
EUCTR2008-000833-23-ITAZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO
Not Yet Recruiting
Phase 3
A pilot investigation of the effects of Baclofen on a quantitative electroencephalographic predictor of relapse to alcohol dependence.Alcohol Use DisorderMental Health - Other mental health disorders
ACTRN12613000372785Royal Adelaide Hospital20
Active, Not Recruiting
N/A
A placebo controlled trial with Baclofen for the treatment of GERD patients with incomplete PPI responseGastroesophageal reflux disease
EUCTR2009-017351-96-BEZleuven
Active, Not Recruiting
Phase 1
Study investigating the effect of baclofen in patients with postprandial regurgitation or belchingRumination syndrome and supragastric belchingMedDRA version: 14.0Level: LLTClassification code 10039292Term: Rumination disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 14.0Level: LLTClassification code 10004222Term: BelchingSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
EUCTR2011-002745-35-BEZLeuven20