Assisted vs Unassisted Domiciliary Alcohol Detoxification: A Randomised Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Succesful Detoxification
Study Overview
Brief Summary
Alcohol Use Disorders (AUD) form a major public health issue in India. In a densely populated country with limited mental health resources, it is challenging to treat those with AUD appropriately. Detoxification is the first step in dealing with clinically significant AUD. Institution based detoxification is not universally available and home based detoxification is mired with poor outcomes with people resuming drinking behaviour. This trail therefore aimed to study the effect of a psychosocial intervention to improve the outcome of domiciliary alcohol detoxification. The intervention involved Brief Interventions for alcohol and daily telephone monitoring and psychosocial support of patients undergoing home detoxification.
Detailed Description
Background: Alcohol use is a major contributor to the worldwide disease burden. Alcohol consumption has dropped in high-income nations over the last decade, whereas it has increased in some low- and middle-income countries in Southeast Asia, including India, where alcohol use resulted in 3.4 million deaths and 14.7 million disability-adjusted life years for the year 2019.
According to World Health Organization (WHO) estimates, total adult alcohol per capita consumption (APC, in liters of pure alcohol) in India has rapidly increased from 2.3 liters (2000) to 5.5 liters (2018), with further rises anticipated until 2025, thus making alcohol use disorders an important public health issue which needs urgent attention from all stakeholders.
A considerable proportion of persons in India with Alcohol Use Disorder (AUD) do not have access to treatment for their alcohol-related disorders, resulting in an 86 percent treatment gap. Community based care options being limited; treatment for AUD is largely dependent upon institutional care, which is both limited and strained. AUD encompasses a broad range of drinking behaviors, however for the purpose of this study the term AUD will refer to drinking behavior needing clinical attention.
Detoxification is the initial stage in therapy for AUD. It can take place in the community or in an inpatient facility; the option is based on the degree of the alcohol use. Evidence suggests that community detoxification is preferable to inpatient detoxification in terms of overall success, cost-effectiveness, feasibility, treatment gap reduction, and client acceptability.
Domiciliary alcohol detoxification is a process where the management of detoxification is advised at the level of patient's home, where an alcohol dependent patient is safely detoxified without admission to an inpatient unit. Whereas in assisted domiciliary alcohol detoxification additional monitoring is provided while the patient undergoes detoxification in the community. The implementation of Mental Health Care Act 2017 recommends treatment of the patient in the community, thus domiciliary detoxification is a step in that direction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consenting male patients aged between 18-65 years who presented in alcohol withdrawal state and were advised Domiciliary Detoxification by treating doctor.
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention Group
All received care for alcohol withdrawal state as is routinely provided at the centre by their respective treating doctors and followed up as directed. All treatment and follow up decisions were made by the respective treating doctors. Study team did not have any role in it.
In addition all received a session of Brief Intervention (BI) for alcohol, at the time of recruitment and again after completing detoxification. Further, patient or designated caregiver received daily phone calls and Information was provided regarding any queries related to their withdrawal or detoxification process. Adverse outcomes such as sedation, seizure, confusion were enquired for and records were kept. Patient was encouraged to continue the treatment and report back for scheduled follow ups and in case of any adverse outcomes patient was asked to report back to the treating doctor and an appointment was facilitated. Phone calls were discontinued once detoxification (CIWA < 8) was complete.
Intervention: Psychosocial (Other)
Control Group
All participants received care for alcohol withdrawal state as is routinely provided at the centre by their respective treating doctors and followed up as directed. All treatment and follow up decisions were made by the respective treating doctors. Study team did not have any role in it.
Outcomes
Primary Outcomes
Succesful Detoxification
Time Frame: Up to four weeks
Proportion of participants successfully completing detoxification as indicated by CIWA score of less than 8
Secondary Outcomes
- Abstinence at one month(One month)
Investigators
Dr Sneha B Suresh
Principle Investigator
Goa Medical College