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Comparing the efficacy of Naltrexone and Baclofen combination over only Naltrexone on craving in alcohol dependence by using neuroimaging

Effect of naltrexone (50mg/day)and baclofen (40mg/day)combination on craving resting and cue related functional brain connectivity,among patients with alcohol dependence : an open label, randomized pharmaco-fMRI study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085974
Enrollment
30
Registered
2025-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: F102- Alcohol dependence Health Condition 3: F102- Alcohol dependence

Interventions

Intervention1: Effect of Naltrexone(50mg/day) and Baclofen(40mg/day) combination on craving, resting and Cue related functional brain connectivity: Patients will be randomly assigned into two groups

Sponsors

CENTRAL INSTITUTE OF PSYCHIATRY,RANCHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with Alcohol dependence, current use, continuous (6C40.20) as per international classification of diseases 11th (ICD-11) and F10.2 (ICD-10) clinical description and diagnostic guidelines (WHO,2019) 2.Male 3 Age between 18 and 50 yrs. 4. Ready to give informed consent.

Exclusion criteria

Exclusion criteria: 1.Not willing to give consent. 3.Any other co-morbid substance abuse except nicotine and caffeine 4.Participants having any co-morbid psychiatric disorders. 5.Participants having any contraindication for fMRI study. 6.Patients with complicated withdrawal (E.g. Delirium Tremens, Seizure)

Design outcomes

Primary

MeasureTime frame
1.Change in craving in alcohol use disorder with naltrexone and baclofen combination over naltrexone alone as assessed by Alcohol Craving Questionnaire 2.Change in craving in alcohol use disorder with naltrexone and baclofen combination over naltrexone alone as assessed by OCDSTimepoint: assessed over baseline and day 24—

Secondary

MeasureTime frame
1.Change in resting-state functional connectivity of the Executive Control Network (ECN) among patients with alcohol dependence, assessed using resting-state fMRI 2.Change in cue-related functional connectivity of the Executive Control Network (ECN) among patients with alcohol dependence, assessed using task-based fMRI with alcohol-relatedTimepoint: 1.Resting-state functional connectivity of ECN Assessed at Baseline (Day 0) & Day 24. 2.Cue-related functional connectivity of ECN Assessed at Baseline (Day 0) & Day 24 during fMRI with alcohol-related cues.—

Countries

India

Contacts

Public ContactProf Dr Sourav Khanra
souravpsy@gmail.com7903302259

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026