Skip to content

Comparing two common medicines for cravings and sleep problems during alcohol recovery

A Comparison Study of Gabapentin versus Baclofen in Insomnia Associated with Alcohol Use Craving for Alcohol and Alcohol Consumption Parameters - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106454
Enrollment
180
Registered
2026-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: F102- Alcohol dependence

Interventions

Intervention1: Baclofen: Baclofen is a GABA -B agonist, reduces CNS excitability commonly used to manage craving and withdrawal effects in alcohol dependence. It helps maintain abstinence and reduce d

Sponsors

Bhopal Memorial Hospital and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male 2. Aged between 18-45 years 3. Is fulfilling the criteria of DSM-5 of Alcohol Use Disorder 4. Detoxified at the in-patient or out-patient Psychiatry department of BMHRC 5. Is assessed to be suffering from IAAC at the time of completion of detoxification 6. Can read Hindi or English 7. Is willing to give informed consent

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA 1. Any other co-morbid substance use disorder other than Nicotine Use Disorder. 2. Any co-morbid psychiatric Disorder like Major Depression, Bipolar Mood Disorder, Schizophrenia etc. that can affect sleep. 3. Presence of any co-morbid medical conditions that contradicts the use of Gabapentin or Baclofen (Gabapentin and Baclofen primarily eliminated via kidneys). 4. On any Medication that is known to affect sleep e.g. sedating antidepressants, anticonvulsants, antipsychotic agents, centrally acting antihistamines or antihypertensives, oral corticosteroids, sedative-hypnotics, psychomotor stimulants, or theophylline as part of a General Medical Condition. 5. Known case of co-morbid Neurological condition, Obstructive Sleep Breathing Disorder or any sleep disorder. 6. Most Common adverse effects associated with Baclofen â?? oversedation, confusion, muscle weakness, vertigo, and nausea and with Gabapentin â?? dizziness, fatigue, ataxia, somnolence, nausea, etc. 7. History of hypersensitivity to Gabapentin or Baclofen

Design outcomes

Primary

MeasureTime frame
Assessment of sleep parameters post detoxification in alcohol dependence.Timepoint: 0 week( Baseline) , 1 week, 4 week, and 8 week.

Secondary

MeasureTime frame
Assessment of craving post detoxification in alcohol dependence.Timepoint: 0 week( Baseline) , 1 week, 4 week, and 8 week.

Countries

India

Contacts

Public ContactSanjukta Ghosh

BMHRC

sanjuktaghosh18@gmail.com9664518982

Outcome results

None listed

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