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CTRI Number  CTRI/2025/12/098269 [Registered on: 01/12/2025] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Telemidicine based treatment for people with alcohol problems  
Scientific Title of Study   TELEMEDICINE-ASSISTED MANAGEMENT OF ALCOHOL WITHDRAWAL VERSUS STANDARD OF CARE: A RANDOMISED 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  Ram Parkash 
Designation  Junior Resident 
Affiliation  PGIMER CHANDIGARH 
Address  Drug deaddiction and treatment centre, Dept of Psychiatry, Postgraduate Institute of Medical Education and Research Chandigarh, India 160012 CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  9877474633  
Fax    
Email  ramparkashp87@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Ghosh 
Designation  Additional Professor 
Affiliation  PGIMER CHANDIGARH 
Address  Drug deaddiction and treatment centre, Dept of Psychiatry, Postgraduate Institute of Medical Education and Research Chandigarh, India 160012 CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  9815890436  
Fax    
Email  ghoshabhishek12@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Ram Parkash 
Designation  Junior Resident 
Affiliation  PGIMER CHANDIGARH 
Address  Drug deaddiction and treatment centre, Dept of Psychiatry, Postgraduate Institute of Medical Education and Research Chandigarh, India 160012 CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  9877474633  
Fax    
Email  ramparkashp87@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate institute of Medical Education and Research Chandigarh, India 160012 
 
Primary Sponsor  
Name  Postgraduate institute of Medical Education and Research Chandigarh, India 160012 
Address  Postgraduate institute of Medical Education and Research Chandigarh, India 160012 
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 Ram Parkash  Postgraduate Institute of Medical Education and Research  Drug deaddiction and treatment centre, Dept of Psychiatry, Postgraduate Institute of Medical Education and Research Chandigarh, India 160012
Chandigarh
CHANDIGARH 
9877474633

ramparkashp87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee(intramural) PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of care for alcohol withdrawal management  Participants randomized to the Standard of Care (SoC) arm will receive a fixed-dose chlordiazepoxide regimen for alcohol withdrawal management based on the clinical assessment conducted during a single in-person visit on Day 1. A psychiatrist will complete a comprehensive evaluation, including CIWA-Ar scoring, medical history, and mental status examination. Based on clinical judgment and severity, one of two institutional fixed-dose tapers will be prescribed: Moderate dependence: 5-day taper starting at 20 mg QID, reducing to 5 mg BID Severe dependence (but not requiring inpatient care): 7–10-day taper starting at 40 mg QID ± PRN doses, tapering to 10 mg at night by Day 10 Participants will receive written instructions on medication timing and symptom monitoring. No proactive follow-up or daily contact will occur. Reactive telephonic support will be available during clinic hours, and participants will be advised to seek help for worsening symptoms or adverse effects. A named caregiver will assist with medication administration and monitor for red-flag symptoms including confusion, seizures, or continued alcohol use despite medication. Caregivers will be coached on recognizing emergencies and contacting the study team 24×7, and instructed to bring participants for urgent or in-person care if red flags emerge. A scheduled follow-up between Days 7–10, in person or via phone, will assess treatment completion, adherence, adverse events, and alcohol use. Participants requiring emergency transfer, inpatient care, or early in-person review due to red-flag symptoms or non-adherence prior to the scheduled follow-up will be classified as SoC failures. 
Intervention  Telemedicine assisted benzodiazepines based alcohol withdrawal management  TAMAL will be implemented as a hybrid model for managing alcohol withdrawal in a structured home-based setting using telemedicine. The intervention begins with an in-person assessment on Day 1, during which participants are screened for eligibility, provided program information, and given an educational leaflet. After obtaining informed consent, withdrawal severity will be assessed using the CIWA-Ar scale. Based on this score and clinical judgment, a symptom-triggered chlordiazepoxide regimen will be started. The treating physician will determine the initial dose and dispense medication sufficient for Days 2–6, tailored to anticipated need. From Day 2 to Day 6, participants will be monitored remotely through daily video or telephonic consultations conducted by the thesis candidate. These interactions will assess alcohol use, withdrawal symptoms, craving, and adherence. On Day 2, participants will take 25% of the previous day’s dose before the consultation. During each consultation, CIWA-Ar will be administered. If the score is 15, an additional dose will be authorized and administered under family supervision. If alcohol has been consumed but symptoms are absent, caregivers will be instructed to monitor and initiate medication when symptoms appear. Reasons for alcohol use will be explored, and doses adjusted as needed. CIWA-Ar assessments will continue on Days 3–6. If symptoms persist, alcohol use continues, or significant new symptoms emerge, additional doses will be prescribed. Participants reporting red-flag symptoms such as confusion, seizures, severe agitation, or ongoing alcohol use despite medication will be referred for in-person evaluation or inpatient care. If symptoms resolve, caregivers will guide benzodiazepine tapering according to a predefined schedule. Teleconsultation support remains available, and participants may contact the team at any time for clinical concerns. At enrolment, a contact plan for daily follow-up will record the participant phone number plus an alternate contact, preferred contact times, and consent to contact caregivers if unreachable. Adherence support includes SMS/WhatsApp reminders 1–2 hours before scheduled calls and a flexible ±3-hour window. A named caregiver will be trained to recognize red-flag symptoms and contact the team 24×7. Emergence of red flags will prompt immediate in-person contact. Between Days 7–10, participants will attend an in-person follow-up for reassessment, collection of unused medication, feedback, and planning for relapse prevention or long-term treatment. The intervention duration for both SoC-A and TAMAL is one week, after which routine outpatient or inpatient care will continue. Participants requiring emergency transfer, inpatient care, early in-person review, or who do not adhere to the protocol will be classified as TAMAL failures. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants eligible for the study must meet the diagnostic criteria for Alcohol Use Disorder (AUD) as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Individuals must express willingness to undergo telemedicine-assisted ambulatory alcohol withdrawal management and have access to a functional smartphone with a stable internet connection to facilitate remote monitoring. To ensure safety in a non-inpatient setting, only those without a history of complicated withdrawal, such as delirium tremens, will be included. Participants should not have any comorbid severe psychiatric disorders (e.g., acute psychosis or high suicide risk) or severe physical illnesses that would necessitate inpatient medical management (e.g., decompensated liver disease). Additionally, a responsible adult family member must be available at home to support medication adherence and participate in daily teleconsultations. Finally, clinical judgment must confirm that the patient does not require inpatient detoxification at the time of enrollment. 
 
ExclusionCriteria 
Details  Participants will be excluded from the study if they or their caregivers are unwilling or unable to cooperate with the telemedicine-assisted protocol, including daily follow-ups and medication monitoring. Individuals previously diagnosed with a comorbid severe mental illness, such as schizophrenia, bipolar disorder, or other psychotic disorders, will be excluded due to the increased complexity of clinical management. Additionally, those presenting with comorbid severe physical illnesses—such as significant hepatic or renal dysfunction, including decompensated liver disease or advanced kidney disease—will be excluded, given the heightened risk of medical complications requiring inpatient care. These exclusion criteria are intended to ensure patient safety and the appropriateness of ambulatory management in a home-based setting. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Treatment retention at the first follow-up assessment.
Treatment retention will be defined by the proportion of participants who follows up at the outpatient clinic at between 7 and 10 days of BZD based detoxification. Those who do not follow-up during this window, or, follow up later, will be considered as “not-retained” in treatment. Participants, asked to come earlier than 7 days for in-person follow-up for dose adjustment, will be asked also to come between 7 and 10 days.
 
7-10days 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment retention will be assessed at the second follow-up (28 ± 7 days). Alcohol outcomes—abstinence status, total abstinent days, 7-day point-prevalence abstinence, number of heavy drinking days, average drinks per drinking day, and craving/withdrawal severity—will be measured at both follow-ups. Treatment satisfaction and quality of life will also be assessed at both points, while telehealth satisfaction (TAMAL only) will be measured at the first follow-up. Treatment-related outcomes at the first follow-up include BZD side effects, adherence, therapeutic relationship, perceived physician empathy, early in-person follow-up need, and acceptability. The need for more intensive treatment will be assessed at both follow-ups. TAMAL protocol adherence will be recorded as the percentage contacted within the first two days of detox  7-10days and 21-35days 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   09/12/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The Global Burden of Disease Study (2016) identified alcohol as a leading risk factor, accounting for 2.8% of all deaths and 4.2% of DALYs worldwide. In India, alcohol consumption is particularly high among males aged 15–49 years, contributing to 12.2% of male deaths in this group (GBD, 2016). The WHO Global Status Report (2024) attributes approximately 2.6 million deaths annually to alcohol, of which 2 million are men (WHO, 2024). Alcohol use disorder and withdrawal contribute significantly to morbidity and mortality.

Retention of treatment in substance use disorder programs has also been shown to improve overall outcomes, engage in gainful work, improve health, and reduce criminal behavior. Therefore, one of the main objectives of treatment is to keep the person with a substance use disorder in the treatment network. However, it is noteworthy that substance use treatment settings experience substantial dropout rates. According to some theories, the biggest dropout rates happen during the first few months of treatment and can reach 50% within the first month.

Perceived behavioural control barriers—such as unstable life schedules, transportation challenges, childcare responsibilities, housing instability, and other logistical limitations—significantly diminish clients’ ability to consistently attend treatment sessions and are strongly associated with early dropout. Patients who remained in treatment longer experienced progressively greater improvements in risk-adjusted substance use measures, psychiatric symptom severity, and social functioning compared with those whose episodes were shorter.

Abrupt cessation of heavy or prolonged alcohol use may precipitate AUD (ALCOHOL USE DISORDER), whose manifestations range from tremor, autonomic hyperactivity and severe anxiety to seizures and delirium tremens. Benzodiazepines are the first-line pharmacological treatment for alcohol withdrawal, effective at reducing withdrawal severity and preventing seizures and delirium. Major guidelines therefore recommend benzodiazepine-based regimens (eg. diazepam, chlordiazepoxide, lorazepam) using either fixed-schedule or symptom-triggered approaches guided by validated scales such as CIWA-Ar.

Traditionally, inpatient or closely supervised outpatient regimens have been used for the initial management of moderate to severe Alcohol use disorder because of the risk of rapid deterioration (seizures, delirium). However, mild–moderate Alcohol use disorder can be safely managed in ambulatory settings with careful assessment, use of symptom-triggered benzodiazepine protocols, standardized monitoring (CIWA-Ar), and access to rapid escalation (hospital transfer) if needed. Outpatient symptom-triggered management can reduce benzodiazepine exposure and length of treatment compared with fixed schedules in selected patients.

Barriers to effective, accessible Alcohol use disorder management — particularly in low-resource settings including parts of India — include limited specialist availability, need for repeated face-to-face visits, stigma, travel and cost burdens, and variable control/regulation of psychotropic medications (which may complicate dispensing and follow-up). Benzodiazepines are prescription-regulated in India; their supply and dispensing are subject to national drug regulations and schedules, which can act as a practical barrier to rapid community-based treatment access.

In view of the above argument, the most practical way forward could be initiating treatment with supervised dosing as per the legal requirements followed by utilization of telepsychiatry services to reduce the number of visits, evaluating treatment response, and then providing unsupervised medications to patients.

 

Telemedicine and remote follow-up offer a practical strategy to expand access to Alcohol use disorder care: tele-assessments can increase the retention rate and reduce the number of required in-person visits, allow supervised initial evaluation or early follow-up, enable symptom-triggered dosing advice, and triage patients needing escalation to inpatient care. A hybrid approach — initial face-to-face assessment for patients at higher medical risk or when immediate supervised administration is needed, followed by telemedicine-supported outpatient symptom-triggered benzodiazepine regimens for stable patients — may be the most pragmatic and scalable model.

Given these considerations, a feasible pathway could be: in-person initial assessment and supervised dosing when clinically indicated, followed by telemedicine assisted benzodiazepine based alcohol withdrawal management for patients who meet stability and safety criteria (clear alcohol history, reliable caregiver or contact, no prior severe withdrawal complications, no major comorbidities that increase benzodiazepine risk). This model aims to increase the retention rate in treatment . This model also aims improvements by the first and second follow-ups: higher point-prevalence 7-day abstinence and greater total days abstinent, fewer heavy-drinking days and lower average drinks per drinking day, and reduced severity of craving and withdrawal; additionally, patient-reported outcomes (treatment satisfaction and quality-of-life—with telehealth satisfaction measured at the first follow-up) should improve, while treatment-related metrics (timely identification of benzodiazepine side-effects, better adherence monitoring, preserved therapeutic rapport/empathy, fewer unscheduled early in-person visits and lower need for hospitalization/ED visits) are expected to show favorable signals.

To formally evaluate this approach, we start this telemedicine assisted management of alcohol withdrawal (TAMAL) at our centre. There are no randomized controlled trials directly comparing standard in-person supervised benzodiazepine withdrawal induction with a telemedicine-assisted model in India. Accordingly, we designed a randomized study to compare standard of care (SoC: in-person supervised benzodiazepine initiation and monitoring) with TAMAL with the primary outcome being treatment retention at one week and secondary outcomes will include treatment retention at the second follow-up (28 days ±7 days) and, at both the first and second follow-ups, alcohol-related measures (7-day point-prevalence abstinence and total days abstinent during follow-up; heavy-drinking days in the prior week; average drinks per drinking day in the prior week; and severity of craving and withdrawal using CIWA-Ar), patient-reported outcomes (treatment satisfaction and quality-of-life at both visits, with telehealth satisfaction in the TAMAL arm measured at the first follow-up only), and treatment-related metrics chiefly assessed at the first follow-up (presence/absence of benzodiazepine side-effects via checklist, benzodiazepine adherence using a validated instrument, therapeutic relationship/physician-empathy, percent asked to return for an unscheduled in-person visit within 7 days, and TAMAL acceptability), while the need for more intensive care (hospitalization, ED visit, or scheduled inpatient substance-use treatment) will be recorded at both follow-ups.

 


 
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