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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
Jubilee Mission Medical College and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Withdrawal Symptoms

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

    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
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    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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