A study comparing oral Naltrexone and oral Disulfiram for preventing relapse in people with alcohol use disorder

Efficacy of oral Naltrexone versus oral Disulfiram in relapse prevention of alcohol use disorder: An open-label randomized controlled clinical study - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100822

Enrollment

Registered

2026-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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: ORAL NALTREXONE: ORAL NALTREXONE 50MG Tablet to be given once daily for 24 weeks. Control Intervention1: ORAL DISULFIRAM: ORAL DISULFIRAM 250MG Tablet to be given once daily for 24 week

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 65 years diagnosed with alcohol use disorder (AUD) according to DSM 5 TR criteria. Patients who are willing and able to provide written consent for the study. Patients who are medically stable and capable of complying with study procedures and scheduled follow-up visits.

Exclusion criteria

Exclusion criteria: Patient in active alcohol withdrawal with CIWA Ar Score more than 09. Patient with severe medical comorbidities including liver failure, renal failure or uncontrolled cardiovascular disease. Patients with history of hypersensitivity or contraindication to naltrexone or disulfiram. Patients with presence of other substance disorder (excluding nicotine) or severe psychiatric disorder necessitating alternative treatment.

Design outcomes

Primary

Measure	Time frame
To assess and compare relapse rate among patients who received oral naltrexone or oral disulfiram treatment during the study periodTimepoint: Baseline, Week two, Week four, Week Eight	—

Secondary

Measure	Time frame
To measure & compare reductions in alcohol craving & consumption levels in both groups. To compare the tolerability, adverse effects, & safety profiles of naltrexone & disulfiram.Timepoint: Baseline, 2 weeks, 4 weeks, 8 Weeks, 12 Weeks	—

Countries

India

Contacts

Public ContactDr Jeevan Atmaram Pawar

Shri Bhausaheb Hire Government Medical College

jeevanpsy96@gmail.com9420440469

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026