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Alcohol Withdrawal SymptomsNCT03470168

Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome

A study testing Hyperbaric Oxygenation Therapy and Normobaric Oxygenation therapy in people with Alcohol Withdrawal Symptoms and Delirium Tremens (DTs), run by Jubilee Mission Medical College and Research Institute.

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

A 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group using simple randomization technique. (Liver function tests) GGT, ALT and AST levels and MCV (Mean corpuscular volume) at admission and 2 weeks later were estimated. Read more about this study

Who is it for?
Ages 20 to 60 years, men only
What is being tested?
Hyperbaric Oxygenation Therapy and Normobaric Oxygenation therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
Nov 2014to Apr 2016
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 20 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male patients aged between 20-60 years with alcohol dependence as per ICD-10 criteria, who presented with AWS and DTs on admission or during the course in our ward were recruited to the study.

Who cannot join

  • Those patients suffering from severe physical illness incapacitating for psychiatric evaluation, who are mentally retarded, who have primary psychiatric disorders like psychosis, mood disorder and those with neurodegenerative disorders like Dementia, Cerebrovascular accidents were excluded.

About this study

A 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group using simple randomization technique. (Liver function tests) GGT, ALT and AST levels and MCV (Mean corpuscular volume) at admission and 2 weeks later were estimated. Daily withdrawal symptoms were assessed using the Clinical Institute Withdrawal Assessment scale (CIWA-Ar) and DTs by Delirium Observation Screening (DOS) Scale (version 0 - 1). The data collected from the two groups were compared.

Read the detailed description

This is a prospective randomized study conducted in the de-addiction ward of department of Psychiatry, Jubilee Mission Medical College, Thrissur, Kerala. The study period was from 16/11/2014 to 30/04/2016 (17 months and 14 days). This study was approved by the Institutional Review Board. Male patients aged between 20-60 years with alcohol dependence as per ICD-10 criteria, who presented with AWS and DTs on admission or during the course in our ward were recruited to the study. Those patients suffering from severe physical illness incapacitating for psychiatric evaluation, who are mentally retarded, who have primary psychiatric disorders like psychosis, mood disorder and those with neurodegenerative disorders like Dementia, Cerebrovascular accidents were excluded. In each case the patient and relatives were explained about the purpose of the study, its nature and the possible advantages and disadvantages of taking part in the study. An informed consent for the study was obtained from the patient as well as the relatives. Each subject was evaluated by a proper history, general examination, systemic examination, detailed mental status examination, laboratory investigations and psychometric evaluation (if needed) at the time of admission. The intended laboratory investigations were γ-glutamyl transferase (GGT), Alanine aminotranferease (ALT), aspartate aminotransferase (AST) and MCV (mean corpuscular volume of RBCs). These were done at time of recruitment. The severity of withdrawal symptoms was assessed using the Clinical Institute Withdrawal Assessment scale (CIWA-Ar) and that for delirium was rated using the Delirium Observation Screening (DOS) Scale (version 0 - 1). All patients had an ECG and a baseline echocardiography to assess their cardiac status. The echocardiography was repeated at the end of 2 weeks. Parameters to be studied included ejection fraction, and end systolic residual volume. All the patients had an ENT consultation to rule out any tympanic membrane pathologies.

The total of 30 patients divided to A: Treatment group and B: Control using Simple randomization technique using random number generating software (ver. 1). A, received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day. B were also taken inside the Hyperbaric Chamber, but received only normobaric oxygen therapy for the same period of time at 1 ATA. All of the cases received all standard medications. Hyperbaric oxygenation was done at our hospital in a monoplace chamber (Oxicab,HyperbaricSAC, Peru). The entire session was carried out in presence of the Hyperbaric Physician and technician. Prior to this therapy the documentation of pulse rate, Blood Pressure and Blood sugar were done as standard procedure. The Hyperbaric sessions were done for 10 days in a row one time daily. Daily general examination, systemic examination, detailed mental status examination and administration of CIWA scale and DOS scale were carried out till the day of discharge.

Laboratory investigations were repeated after two weeks. The patients were discharged when the biological functions were adequate, physical and mental conditions were stable and when they were motivated to remain abstinent from alcohol. Parameters assessed in two groups were compared.

Being tested
Hyperbaric Oxygenation Therapy, Normobaric Oxygenation therapy
Medical subject headings
Alcohol Withdrawal Delirium

What participants receive

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

  • Hyperbaric Oxygenation TherapyDevice

    Also called Treatment group

    Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.

  • Normobaric Oxygenation therapyDevice

    Also called Placebo group

    Received the Normobaric Oxygen therapy treatment at 1 ATA for 90 minutes each day.

Study groups in NCT03470168
Study groupRoleWhat they receive
Hyperbaric Oxygen TherapyExperimentalReceived the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.
Receives: Device: Hyperbaric Oxygenation Therapy
Placebo groupPlacebo comparatorwere also taken inside the Hyperbaric Chamber, but received only normobaric oxygen therapy for the same period of time at 1 ATA
Receives: Device: Normobaric Oxygenation therapy

What is being measured

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

  1. Rate of improvement

    faster recovery from DTs and withdrawal symptoms.

    Measured: 1 year

Timeline

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

  1. First posted19 Mar 2018
  2. Study startNov 2014
  3. Primary completionApr 2015
  4. Study completionApr 2016

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group using simple randomization technique.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03470168
Sponsor's protocol ID
25/16/IEC/JMMC&RI
Status last verified
Mar 2018
First submitted
2 Mar 2017
Last updated
19 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sassi,F.(ed.), Tackling Harmful Alcohol Use: Economics and Public Health Policy, OECD Publishing, Paris 2015.

  • World Health Organization (WHO) -Global Status report on Alcohol and Health -2014

  • American psychiatric association; Diagnostic and statistical manual of mental disorders; 4th edition; Text Revision (DSM IV TR)

  • Caetano R, Clark CL, Greenfield TK. Prevalence, trends, and incidence of alcohol withdrawal symptoms: analysis of general population and clinical samples. Alcohol Health Res World. 1998;22(1):73-9.

    PubMed 15706737

Questions about this trial

What is this clinical trial studying?

A study testing Hyperbaric Oxygenation Therapy and Normobaric Oxygenation therapy in people with Alcohol Withdrawal Symptoms and Delirium Tremens (DTs), run by Jubilee Mission Medical College and Research Institute.

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 1 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Rate of improvement (time frame: 1 year). 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 NCT03470168, which also lists 4 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 19 Mar 2018.

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