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.
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
- Conditions the study is for
- Alcohol Withdrawal Symptoms, Delirium Tremens (DTs)
- 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 group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day. Receives: Device: Hyperbaric Oxygenation Therapy |
| Placebo group | Placebo comparator | were 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.
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.
- First posted19 Mar 2018
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Withdrawal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- INCRE fellowship from DBT, govt of India
- Responsible party
- Principal investigator, Dr Geomy George Chakkalakkudy, Jubilee Mission Medical College and Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygenation in Treatment of Alcohol Dependence Syndrome
- ClinicalTrials.gov ID
- NCT03470168
- Acronym / sponsor ID
- 25/16/IEC/JMMC&RI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Collaborators
- INCRE fellowship from DBT, govt of India
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group using simple randomization technique.
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Device: Hyperbaric Oxygenation TherapyReceived the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day. |
| Placebo group | Placebo comparator | Device: Normobaric Oxygenation therapywere also taken inside the Hyperbaric Chamber, but received only normobaric oxygen therapy for the same period of time at 1 ATA |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygenation TherapyAlso: Treatment groupReceived the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day. | Device | Hyperbaric Oxygen Therapy |
| Normobaric Oxygenation therapyAlso: Placebo groupReceived the Normobaric Oxygen therapy treatment at 1 ATA for 90 minutes each day. | Device | Placebo group |
Primary outcome
Rate of improvement
Time frame: 1 year
faster recovery from DTs and withdrawal symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- BackgroundSassi,F.(ed.), Tackling Harmful Alcohol Use: Economics and Public Health Policy, OECD Publishing, Paris 2015.
- BackgroundWorld Health Organization (WHO) -Global Status report on Alcohol and Health -2014
- BackgroundAmerican psychiatric association; Diagnostic and statistical manual of mental disorders; 4th edition; Text Revision (DSM IV TR)
- Background: PubMed 15706737Caetano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.