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Comparison of drinking outcomes in patients with alcohol dependence treated with oral naltrexone with postal delivery or tele follow up

Comparison of short-term drinking outcomes between distant patients with alcohol dependence treated with postal delivery of oral naltrexone and tele-follow-up (tele-PoN) versus usual dispensing of oral naltrexone along with telefollow-up (tele-DoN): an exploratory randomized controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077636
Enrollment
90
Registered
2024-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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: Teledon: 30 patients will be recruited in this arm and will be given tele follow up for 12 weeks with the freedom to take medications subsequently from anywhere. Intervention2: Telepon:

Sponsors

AIIMS KALYANI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ICD-11 alcohol dependence patients taking 50 mg of oral naltrexone (as per standard guidelines issues by MoHFW, GoI and CPG,IPS) at least for one month. 2. Distant patients as per operational definition. 3. Patients with valid postal address in India where speed post services of Indian Postal departmental are available. 4. Availability of receiving person at the delivery point. 5. Patient should be ready for physically visiting the ATF after 12 weeks for follow up. 6. Patients having a valid phone number with mobile handset preferably smartphone where he can be contacted for tele-reminders

Exclusion criteria

Exclusion criteria: 1. Diagnosed case of severe mental illness. 2. substance dependence with active usage.(except alcohol, tobacco and nicotine) 3. Contraindications of prescribing naltrexone. 4. Complete abstinence from alcohol in iast one month. 5. Patients in active alcohol withdrawal as per clinical assessment.

Design outcomes

Primary

MeasureTime frame
To compare the time to first episode of heavy drinking between distant patients with alcohol dependence treated with tele-PoN, teleDoN and TAUTimepoint: At baseline, 4 weeks, 8 weeks, 12 weeks—

Secondary

MeasureTime frame
To compare heavy drinking days, number of drinking days, drink per drinking days & alcohol craving among distant patients with alcohol dependence treated with tele-PoN, tele-DoN & TAU. To compare adherence to treatment among tele-PoN, tele-DoN & TAU arms. To evaluate the safety of oral naltrexone in the treatment armsTimepoint: At baseline, 4 weeks, 8 weeks, 12 weeks—

Countries

India

Contacts

Public ContactDr Raviraj Singh Nagarkoti

AIIMS KALYANI

aniruddha.psy@aiimskalyani.edu.in8968979239

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026