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A study to compare the effectiveness of 100 mg naltrexone and 50 mg naltrexone in participants who have moderate to severe alcohol use problems. The main study aim will be to see how long the participants can stay away from alcohol and the side effects with the 2 doses of nalttrexone

A Double-blind, Cross-over, Randomised Controlled Trial to Compare the Effectiveness of Higher Dose Oral Naltrexone with Standard Dose Oral Naltrexone in Moderate to Severe Alcohol Use Disorder - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081102
Enrollment
26
Registered
2025-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: Tablet Naltrexone: Tablet Naltrexone 100 mg, once daily, orally, for 3 months followed by Tablet Naltrexone 50 mg, once daily, orally for next 3 months. Control Intervention1: Tablet Na

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Resident of Gorakhpur and literate enough to understand the questionnaires, fulfilling DSM-5 criteria for alcohol use disorder with severity of alcohol dependence questionnaire (SAD-Q) score of at least 16 (assessed for the preceding 6 months)and Patients willing for inpatient detoxification and abstinence for 1 week.

Exclusion criteria

Exclusion criteria: Presence of other moderate to severe substance use disorders except tobacco. Presence of any major psychiatric condition (except subsyndromal depression or anxiety). Any acute medical or neurological condition or intellectual disability. Any chronic medical conditions (malignancy or chronic pain conditions) that may pose a contraindication for opioid antagonist treatment. History of hypersensitivity to naltrexone in the past. Active use of any opioids (use of any opioids in the last 7 days). Evidence of compromised liver function, with liver enzymes raised more than three times the upper normal limit.

Design outcomes

Primary

MeasureTime frame
1. Number of participants that become abstinent: 2. If relapse, the number of days of abstinence 3. Number of lapses 4. Number of drinks per day: both for lapse and relapse 5. Severity of craving: The severity of craving will be assessed and quantified using the Penn Alcohol Craving Scale. 6. Treatment completion and dropout in each group. Timepoint: At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month.—

Secondary

MeasureTime frame
Serum aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) levels. Treatment emergent adverse events Timepoint: 6 time points: at the end of 1st, 2nd, 3rd, 4th, 5th and 6th months—

Countries

India

Contacts

Public ContactDr LALCHHANDAMA HAUHNAR

All India Institute of Medical Sciences, Gorakhpur

drricha12@gmail.com9999457412

Outcome results

None listed

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