Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Conditions
Interventions
Intervention1: 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 m
Sponsors
Postgraduate institute of Medical Education and Research Chandigarh, India 160012
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 7-10days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 detoxTimepoint: 7-10days and 21-35days | — |
Countries
India
Contacts
Public ContactRam Parkash
PGIMER CHANDIGARH
Outcome results
None listed