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
(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.
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.