Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
Primary Purpose
Alcohol Withdrawal Symptoms, Delirium Tremens (DTs)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyperbaric Oxygenation Therapy
Normobaric Oxygenation therapy
Sponsored by
About this trial
This is an interventional health services research trial for Alcohol Withdrawal Symptoms
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hyperbaric Oxygen Therapy
Placebo group
Arm Description
Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.
were also taken inside the Hyperbaric Chamber, but received only normobaric oxygen therapy for the same period of time at 1 ATA
Outcomes
Primary Outcome Measures
Rate of improvement
faster recovery from DTs and withdrawal symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT03470168
First Posted
March 2, 2017
Last Updated
March 12, 2018
Sponsor
Jubilee Mission Medical College and Research Institute
Collaborators
INCRE fellowship from DBT, govt of India
1. Study Identification
Unique Protocol Identification Number
NCT03470168
Brief Title
Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
Official Title
Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jubilee Mission Medical College and Research Institute
Collaborators
INCRE fellowship from DBT, govt of India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal Symptoms, Delirium Tremens (DTs)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group using simple randomization technique.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric Oxygen Therapy
Arm Type
Experimental
Arm Description
Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
were also taken inside the Hyperbaric Chamber, but received only normobaric oxygen therapy for the same period of time at 1 ATA
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygenation Therapy
Other Intervention Name(s)
Treatment group
Intervention Description
Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.
Intervention Type
Device
Intervention Name(s)
Normobaric Oxygenation therapy
Other Intervention Name(s)
Placebo group
Intervention Description
Received the Normobaric Oxygen therapy treatment at 1 ATA for 90 minutes each day.
Primary Outcome Measure Information:
Title
Rate of improvement
Description
faster recovery from DTs and withdrawal symptoms.
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Sassi,F.(ed.), Tackling Harmful Alcohol Use: Economics and Public Health Policy, OECD Publishing, Paris 2015.
Results Reference
background
Citation
World Health Organization (WHO) -Global Status report on Alcohol and Health -2014
Results Reference
background
Citation
American psychiatric association; Diagnostic and statistical manual of mental disorders; 4th edition; Text Revision (DSM IV TR)
Results Reference
background
PubMed Identifier
15706737
Citation
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.
Results Reference
background
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Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
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