AzTrials
AzTrials

Alcohol Use DisorderNCT05563740

Psychosocial Intervention For Domiciliary Alcohol Detoxification

A study testing Psychosocial in people with Alcohol Use Disorder, run by Dr Sneha B Suresh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Psychosocial
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIndia
Study dates
1 Jan 2020to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Nil

Trial locations and contacts

1 site in 1 country.

India1 site
  • Institue of Psychiatry & Human Behaviour

    Bambolim, Goa, 403202

Other trials in India

About this study

Official title: Assisted vs Unassisted Domiciliary Alcohol Detoxification: A Randomised Control Trial

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.

Read the 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.

The aim of this study was to trail an intervention that assisted a randomly assigned group of patients undergoing domiciliary detoxification. The assistance was through daily phone call monitoring until successful detoxification with brief intervention sessions on two occasions; with the outcome measured as successful detoxification and abstinence at the end of one month.

Methodology:

Study setting: This study was based at the out-patient department of a tertiary care psychiatry hospital in Goa, India.

Study Design: Randomised Control Trial Sample and sample size: 100 consenting male patients aged between 18-65 years who presented in alcohol withdrawal state and were advised Domiciliary Detoxification by treating doctor were included in the study. The sample size was a pragmatic estimate based on feasibility.

Procedure: Eligible patients were approached and written consent was obtained after detailed explanation of the study. Baseline assessment of all participants was done using a) Severity of Alcohol Dependence Questionnaire (SAD-Q) for severity of alcohol dependence. The SAD-Q has been extensively used in a number of studies in India b) Readiness to Change Questionnaire, treatment version (RCQ-TV) for motivation to quit alcohol. This scale is based on Prochaska and DiClemente's stages of change model, for assignment of excessive drinkers to Precontemplation, Contemplation, and Action stages. Researchers throughout the world have used this questionnaire as a simple mean to assess the stage of motivation of an individual and c) Clinical Institute Withdrawal Assessment of Alcohol scale, Revised (CIWA-Ar) for severity of withdrawal. A cut-off of 8 was considered for intake as scores below 8 usually do not need medical management. A vernacular version of the scales was generated using the translation-back translation method. Predesigned semi-structured questionnaire was used to assess the socio-demographic variables and drinking related variables.

Randomisation: Following baseline assessment, randomisation was carried out using pre-randomised and sealed envelopes to assign the subject either into intervention or control group. Randomisation was done by third party not involved in any way with the study. No blinding could be carried out as it was a single investigator study however steps to avoid bias were taken by doing the baseline assessment prior to randomisation.

Both groups (Intervention and Control) 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.

Intervention: The intervention group in addition received a session (approx. 15 min) of Brief Intervention (BI) for alcohol, at the time of recruitment and again after completing detoxification. The BI session was delivered on structured lines based on psychoeducation and personalised feedback. It focussed on making patient aware of the potential harm if alcohol was continued, mainly in terms of medical, social, financial aspects and encouraged abstinence. BI model was selected to keep the intervention simple and feasible. 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.

Outcome assessment: Outcome measurement for successful detoxification was done at every follow up for both groups. A CIWA score of less than 8 was considered as successful completion of detoxification. Similarly, outcome assessment for abstinence at one month was done using the Time Line Follow Back Method after one month of detoxification either in person or by phone call. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. People give retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date using a calendar. This method has been used across wide settings.

Data analysis and interpretation: Data was analysed using the Statistical Package for Social Sciences (SPSS) for Windows software (version 22.0; SPSS Inc., Chicago). Descriptive statistics such as mean and standard deviation (SD) for continuous variables and frequencies and percentages for categorical Variables were calculated. Association between study group and other categorical variables were analysed using chi-square test of independence and unpaired t-test for continuous variables. Level of significance was set at p<0.05.

Ethical considerations: The study received ethical clearance from the Institutional Ethics Committee at The Goa Medical College, Goa. Written Informed consent was obtained after thorough description of the study to the participants in their own vernacular. All data was kept confidential and privacy was ensured. All relevant information was shared with the treating doctor with consent of the patient. Patients in the control group received the same care as is routinely provided at the hospital. Those patients who had resumed drinking at the end of the trial period received brief counselling regarding drinking and were directed to visit for further assistance.

Being tested
Psychosocial
Keywords
Alcohol withdrawal, Home detoxification, Domiciliary Detoxification
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsychosocialOther

    Daily telephone calls with two sessions of Brief Interventions for alcohol

Study groups in NCT05563740
Study groupRoleWhat they receive
Intervention GroupExperimentalAll 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.
Receives: Other: Psychosocial
Control GroupNo interventionAll 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Succesful Detoxification

    Proportion of participants successfully completing detoxification as indicated by CIWA score of less than 8

    Measured: Up to four weeks

Secondary outcomes (1)
  1. Abstinence at one month

    Total duration in days abstinent from alcohol at one month from detoxification measured on Time Line Follow Back method.

    Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start1 Jan 2020
  3. Primary completion30 Sep 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563740
Sponsor's protocol ID
GMC121019
Status last verified
Sep 2022
First submitted
23 Sep 2022
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manthey J, Shield KD, Rylett M, Hasan OSM, Probst C, Rehm J. Global alcohol exposure between 1990 and 2017 and forecasts until 2030: a modelling study. Lancet. 2019 Jun 22;393(10190):2493-2502. doi: 10.1016/S0140-6736(18)32744-2. Epub 2019 May 7.

    PubMed 31076174
  • National Collaborating Centre for Mental Health (UK). Alcohol-Use Disorders: Diagnosis, Assessment and Management of Harmful Drinking and Alcohol Dependence. Leicester (UK): British Psychological Society (UK); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK65487/

    PubMed 22624177
  • GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1345-1422. doi: 10.1016/S0140-6736(17)32366-8.

    PubMed 28919119
  • 4. Hammer JH, Parent MC, Spiker DA, World Health Organization. Global status report on alcohol and health 2018 [Internet]. Vol. 65, Global status report on alcohol. 2018. 74-85 p. Available from: http://www.who.int/substance_abuse/publications/global_alcohol_report/msbgsruprofiles.pdf%0Ahttp://www.ncbi.nlm.nih.gov/pubmed/29355346

  • Rastogi A, Manthey J, Wiemker V, Probst C. Alcohol consumption in India: a systematic review and modelling study for sub-national estimates of drinking patterns. Addiction. 2022 Jul;117(7):1871-1886. doi: 10.1111/add.15777. Epub 2022 Jan 10.

    PubMed 34873774
  • Nadkarni A, Velleman R, Bhatia U, Fernandes G, D'souza E, Murthy P. Home-detoxification and relapse prevention for alcohol dependence in low resource settings: An exploratory study from Goa, India. Alcohol. 2020 Feb;82:103-112. doi: 10.1016/j.alcohol.2019.08.006. Epub 2019 Aug 29.

    PubMed 31473304
  • Nemlekar S, Gaonkar P, Rane A. Domiciliary alcohol detoxification outcomes: a study from Goa, India. J Addict Dis. 2021 Jan-Mar;39(1):105-108. doi: 10.1080/10550887.2020.1826103. Epub 2020 Oct 20.

    PubMed 33079007
  • 8. The Mental Health Care Act 2017. Available from: http://www.prsindia.org/uploads/media/Mental%20Health/Mental%20Healthcare%20Act,%202017.pdf

  • D'Souza PC, Mathai PJ. Motivation to change and factors influencing motivation in alcohol dependence syndrome in a tertiary care hospital. Indian J Psychiatry. 2017 Apr-Jun;59(2):183-188. doi: 10.4103/psychiatry.IndianJPsychiatry_262_15.

    PubMed 28827865
  • Johnson PR, Britto C, Sudevan KJ, Bosco A, Sreedaran P, Ashok MV. Resilience in Wives of persons with Alcoholism: An Indian exploration. Indian J Psychiatry. 2018 Jan-Mar;60(1):84-89. doi: 10.4103/psychiatry.IndianJPsychiatry_271_14.

    PubMed 29736068
  • Baby S, Murthy P, Thennarasu K, Chand PK, Viswanath B. Comparative outcome in patients with delirium tremens receiving care in emergency services only versus those receiving comprehensive inpatient care. Indian J Psychiatry. 2017 Jul-Sep;59(3):293-299. doi: 10.4103/psychiatry.IndianJPsychiatry_260_17.

    PubMed 29085087
  • Gupta A, Murthy P, Rao S. Brief screening for cognitive impairment in addictive disorders. Indian J Psychiatry. 2018 Feb;60(Suppl 4):S451-S456. doi: 10.4103/psychiatry.IndianJPsychiatry_41_18.

    PubMed 29540913
  • Gulati P, Chavan BS, Sidana A. Authors' reply to commentary on "Gulati P, Chavan BS, Sidana A. Comparative efficacy of baclofen and lorazepam in the treatment of alcohol withdrawal syndrome". Indian J Psychiatry. 2019 Nov-Dec;61(6):652-653. doi: 10.4103/psychiatry.IndianJPsychiatry_325_19. No abstract available.

    PubMed 31896877
  • Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.

    PubMed 2597811
  • Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.

    PubMed 10170434

Questions about this trial

What is this clinical trial studying?

A study testing Psychosocial in people with Alcohol Use Disorder, run by Dr Sneha B Suresh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Succesful Detoxification (time frame: Up to four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563740, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.

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