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CTRI Number  CTRI/2024/12/077636 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 06/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of drinking outcomes in patients with alcohol dependence treated with oral naltrexone with postal delivery or tele follow up 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raviraj Singh Nagarkoti  
Designation  Academic Junior Resident  
Affiliation  AIIMS KALYANI  
Address  ROOM NO. G-25 Addiction Treatment Facility (ATF) Department of Psychiatry

Nadia
WEST BENGAL
741245
India 
Phone  9123670805  
Fax    
Email  raviraj.psy_pgt24@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Aniruddha Basu 
Designation  Additional Professor 
Affiliation  AIIMS KALYANI  
Address  ROOM NO. 315 Department of Psychiatry

Nadia
WEST BENGAL
741245
India 
Phone  8968979239  
Fax    
Email  aniruddha.psy@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Raviraj Singh Nagarkoti  
Designation  Academic Junior Resident  
Affiliation  AIIMS KALYANI  
Address  ROOM NO. G-25 Addiction Treatment Facility (ATF) Department of Psychiatry

Nadia
WEST BENGAL
741245
India 
Phone  9123670805  
Fax    
Email  raviraj.psy_pgt24@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
AddictionTreatmentFacility (ATF) Department of Psychiatry AIIMS Kalyani NH-34 Connector Basantapur Saguna Kalyani District- Nadia West Bengal 741245 
 
Primary Sponsor  
Name  AIIMS KALYANI 
Address  AIIMS KALYANI, Nadia, West Bengal 741245 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raviraj Singh Nagarkoti  AIIMS KALYANI   ROOM NO. G-25 Addiction Treatment Facility (ATF) Department of Psychiatry
Nadia
WEST BENGAL 		 9123670805

raviraj.psy_pgt24@aiimskalyani.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H||Substance Abuse Treatment,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  TAU  30 patients will be recruited in this arm and will be followed up for 12 weeks in the OPD as usual. 
Intervention  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. 
Intervention  Telepon  30 patients will be recruited in this arm and will be given tele follow up for 12 weeks with the postal delivery of medications. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the time to first episode of heavy drinking between distant patients with alcohol dependence treated with tele-PoN, teleDoN and TAU  At baseline, 4 weeks, 8 weeks, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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 arms 		 At baseline, 4 weeks, 8 weeks, 12 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Data will be available on reasonable request from PI

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Email/ repository

  6. For how long will this data be available start date provided 30-11-2024 and end date provided 01-02-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Overall 99 patients will be recruited through eligibility criteria. They will be divided into three groups based on computer based random number generator and it will be open label. The groups will be compared based upon postal delivery of oral naltrexone through tele-follow up with usual dispensing via tele-follow up and change in consumption pattern of alcohol will be documented with screening tools. 
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