TELEMEDICINE-ASSISTED MANAGEMENT OF ALCOHOL WITHDRAWAL VERSUS STANDARD OF CARE: A RANDOMISED CONTROLLED TRIAL

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.