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Baclofen in alcohol dependence; open label, Randomised, study

Effect of adjunctive Baclofen on craving, withdrawal, resting and Cue related functional brain connectivity, among patients with alcohol dependence: an Open label, randomized Pharmaco-fMRI study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052725
Enrollment
30
Registered
2023-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: H- Substance Abuse Treatment

Interventions

Intervention1: Tab Baclofen: One group of patients having Alcohol dependence will be given Tablet Baclofen 20mg for first 3 days, 40mg for next 3 days, then 60 mg for next 2 weeks. Total duration of i

Sponsors

Central Institute Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with mental and behavioural disorder due to use of alcohol dependence syndrome, currently using the substance(F10.24) as per International classification of disease 10th (ICD 10) clinical description and diagnostic guidelines( WHO, 1993) who are ready to give consent and severity of alcohol dependence Questionnaire (SADQ) score > 20 that is moderate to severe alcohol dependence.

Exclusion criteria

Exclusion criteria: 1.Not willing to give consent.2. Age 50 years.3.Any other comorbid substance use except nicotine and caffeine.4.Participants having any comorbid psychiatric disorders .Participants having any contraindication for fMRI,6. Patient is receiving any anti craving medication in last 14 days.7. Patients with complicated withdrawal( Delirium Tremens, Seizure)

Design outcomes

Primary

MeasureTime frame
1.Change in craving of alcohol assessed by Alcohol Craving Questionnaire(ACQ-NOW)from baseline to the end of the study. 2.Change in craving of alcohol assessed by Obsessive Compulsive Drinking Scale (OCDS)from baseline to the end of the study. 3. Change in withdrawal assessed by CIWA-Ar from baseline to the end of study.Timepoint: Baseline, Day 8, Day 21—

Secondary

MeasureTime frame
1.Change in resting state brain connectivity of Executive Control Network among patients with alcohol dependence from baseline to the end of the study. 2.Change in cue related functional brain connectivity of Executive Control Network among patients with alcohol dependence from baseline to the end of the study. 3.Change in Clinical Global Index-Improvement(CGI-I) score from baseline to the end of the study. 4.Total dosage of Benzodiazepines required to reach CIWA-Ar below 10 4.Number of days required to reach CIWA-Ar below 10Timepoint: Baseline, Day 8, Day 21—

Countries

India

Contacts

Public ContactSourav Khanra

Central Institute of Psychiatry

souravpsy@gmail.com7903302259

Outcome results

None listed

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