Study of effects of Naltrexone treatment in alcohol dependent patients and influence by genotypes.Naltrexone is an FDA approved medication for treating alcohol dependence

Moderation of Naltrexone treatment response by OPRM1 gene polymorphism among patients with alcohol dependence in India - MNTRBOAD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010848

Enrollment

278

Registered

2017-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Alcohol Dependence Syndrome

Interventions

Intervention1: Naltrexone: Naltrexone is an FDA approved medication for treatment of alcohol dependence Dose:50mg/day Route: per oral Frequency: once per day Duration : 12 weeks Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. ICD 10 criteria for alcohol use disorder. 2. Alcohol use disorder male subjects between the age group 18 to 60 years. 3. Abstinence from alcohol and other substances for 3-7 days. 4. Ability to provide informed consent. 5. One or more relatives or significant others who are willing to encourage medication therapy, adherence and provide follow-up information if contacted by research staff.

Exclusion criteria

Exclusion criteria: 1. Major psychiatric disorder (i.e, schizophrenia, bipolar disorder, seizure disorder, alcohol induced psychotic disorder or dementia). 2. Advanced neurological, cardiovascular, renal, or hepatic disease; active tuberculosis or current febrile illness. 3. AIDS defining illness. 4. Significant laboratory abnormality (alanine aminotransferase/aspartate aminotransferase [ALT/AST] levels of greater than 5 times the top reference limit).

Design outcomes

Primary

Measure	Time frame
The primary outcome measure will be the occurrence of relapse, that is, presence of heavy drinking on a single day as defined by 5 or more standard drinks during any given week of the trial measured by Time-Line Follow-Back(TLFB)Timepoint: Every 2 weeks till the end of 12 weeks	—

Secondary

Measure	Time frame
Other outcome measures will be the time taken to relapse, number of heavy drinking days (as defined by more than 5 drinks/day for males), number of drinks per heavy drinking day as measured by the Time-Line Follow Back method and Obsessive Compulsive Drinking Scale measure, craving measured by obsessive compulsive drinking scaleTimepoint: At end of 12 weeks	—

Countries

India

Contacts

Public ContactNavina Suresh

Sri Ramachandra University

sathianathen6@yahoo.com

Outcome results

None listed

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