AlcoholismPhase 3NCT00136617
Outpatient Treatment of Alcohol Withdrawal Syndrome
A Phase 3 study testing chlordiazepoxide in people with Alcoholism and Alcohol Withdrawal, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients. Objectives: Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication Clinically controlled trial of two regimens for medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Alcohol Withdrawal
- What is being tested?
- chlordiazepoxide
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2003to Sep 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 18
- Fulfilled informed consent
- Abstained from alcohol within the last 72 hours.
- Agree on both treatment regimens.
- Abstinence during 10 days (monitoring and medication period), i.e. treatment with disulfiram or oral alcometer test on every attendance (Lion Alcometer S-D2).
Who cannot join
- Oral alcoholmeter test > 0.1.
- Treatment of AWS within the last week
- 3 earlier attempts at outpatient detoxification within the last 2 months without success.
- Allergy or adverse reactions to chlordiazepoxide
- Treatment with medication in interaction with chlordiazepoxide
- Psychiatric comorbidity within the last year, dependence on other drugs except nicotine dependence
Show all 11Show fewer
- Medically severe comorbidity, especially severe liver insufficiency
- Severe cardiovascular diseases, NIDDM and IDDM.
- A history within the last year of seizures and delirium tremens.
- Patients should be cooperative in terms of cooperation and understanding of the Danish language.
- Females of fertile age without safe contraception, (i.e. IUD, hormone tablets or sterilisation) also pregnant or breastfeeding women were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
Read the detailed description
The objective of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
Patients and Methods:
This study is a prospective analysis of patients admitted to a medical outpatient clinic between August 25, 2003 and July 1, 2006, who experienced AWS. This study is conducted at Copenhagen Hospital Corporation in Copenhagen, Denmark. Patients were divided into two randomized groups: a symptom-triggered treatment versus a fixed-schedule treatment (known) with chlordiazepoxide. They were diagnosed with AWS according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition). They were diagnosed with alcohol dependence according to the ICD-10 (International Statistical Classification of Diseases and Health Related Problems).
Methods:
One hundred fifty consecutive patients who fulfill the inclusion criteria and not the exclusion criteria were offered to participate in the study, i.e. also patients who were detoxified at home or during admission. Patients were scored according to the DSM-IV for AWS and ICD-10 for alcohol dependence, and then they filled out a SAWS (Short Alcohol Withdrawal Scale). The score of 12 was the significant number of splitting patients to mild or moderate AWS. Randomization was done by the Research Unit. Patients were then treated with the traditionally fixed-schedule therapy (day 1, 200mg, chlordiazepoxide decreasing with 25 mg a day) or the new symptom-triggered therapy (up to 300 mg, chlordiazepoxide a day). For up until 10 days, patients monitored themselves for all ten days according to the SAWS. They were asked about mental conditions day 1-14 and every third month using the World Health Organization (WHO)-5 schedule.
On day 10 they filled out an adverse reactions questionnaire on chlordiazepoxide and a DTSQ (Diabetes Treatment Satisfaction Questionnaire) and an ASI (Addiction Severity Index) every third month.
Relapses and intake of any alcohol during a year are monitored.
- Conditions
- Alcoholism, Alcohol Withdrawal
- Being tested
- chlordiazepoxide
- Keywords
- Short Alcohol Withdrawal Scale, Documentation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlordiazepoxideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12
To give the most safe treatment to the patients and reduce the risk of further development of alcohol withdrawal syndrome with seizures and delirium tremens
AWS score day 1, 2, 3, etc.
Use of medication
Patient satisfaction
Wellbeing
Secondary outcomes (2)
Compliance in alcohol treatment
Time to first relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startAug 2003
- Primary completionJul 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ulrik Becker, MD, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136617
- Sponsor's protocol ID
- AWS
- Status last verified
- Feb 2009
- First submitted
- 26 Aug 2005
- Last updated
- 2 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
- ClinicalTrials.gov ID
- NCT00136617
- Acronym / sponsor ID
- AWS
- Conditions
- Alcoholism, Alcohol Withdrawal
- Keywords
- Short Alcohol Withdrawal Scale, Documentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Aug 2005 (estimated)
- 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.
The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
Detailed description
The objective of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
Patients and Methods:
This study is a prospective analysis of patients admitted to a medical outpatient clinic between August 25, 2003 and July 1, 2006, who experienced AWS. This study is conducted at Copenhagen Hospital Corporation in Copenhagen, Denmark. Patients were divided into two randomized groups: a symptom-triggered treatment versus a fixed-schedule treatment (known) with chlordiazepoxide. They were diagnosed with AWS according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition). They were diagnosed with alcohol dependence according to the ICD-10 (International Statistical Classification of Diseases and Health Related Problems).
Methods:
One hundred fifty consecutive patients who fulfill the inclusion criteria and not the exclusion criteria were offered to participate in the study, i.e. also patients who were detoxified at home or during admission. Patients were scored according to the DSM-IV for AWS and ICD-10 for alcohol dependence, and then they filled out a SAWS (Short Alcohol Withdrawal Scale). The score of 12 was the significant number of splitting patients to mild or moderate AWS. Randomization was done by the Research Unit. Patients were then treated with the traditionally fixed-schedule therapy (day 1, 200mg, chlordiazepoxide decreasing with 25 mg a day) or the new symptom-triggered therapy (up to 300 mg, chlordiazepoxide a day). For up until 10 days, patients monitored themselves for all ten days according to the SAWS. They were asked about mental conditions day 1-14 and every third month using the World Health Organization (WHO)-5 schedule.
On day 10 they filled out an adverse reactions questionnaire on chlordiazepoxide and a DTSQ (Diabetes Treatment Satisfaction Questionnaire) and an ASI (Addiction Severity Index) every third month.
Relapses and intake of any alcohol during a year are monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients above the age of 18
- Fulfilled informed consent
- Abstained from alcohol within the last 72 hours.
- Agree on both treatment regimens.
- Abstinence during 10 days (monitoring and medication period), i.e. treatment with disulfiram or oral alcometer test on every attendance (Lion Alcometer S-D2).
Key exclusion criteria (11 listed)
- Oral alcoholmeter test > 0.1.
- Treatment of AWS within the last week
- 3 earlier attempts at outpatient detoxification within the last 2 months without success.
- Allergy or adverse reactions to chlordiazepoxide
- Treatment with medication in interaction with chlordiazepoxide
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 |
|---|---|---|
| chlordiazepoxide | Drug | – |
Primary outcome
To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12
To give the most safe treatment to the patients and reduce the risk of further development of alcohol withdrawal syndrome with seizures and delirium tremens
AWS score day 1, 2, 3, etc.
Use of medication
Patient satisfaction
Wellbeing
2 secondary outcomes
Compliance in alcohol treatment
Time to first relapse
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 2 Mar 2009.
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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.
Ulrik Becker, MD study director
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chlordiazepoxide in people with Alcoholism and Alcohol Withdrawal, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 11 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 2 Mar 2009. 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2009.