AlcoholismPhase 4NCT00431262
Antabuse in Severe Alcoholism: an Open Controlled Study
A Phase 4 study testing antabuse (disulfiram) in people with Alcoholism, run by Psykiatrisk Center Gentofte at 1 site in Denmark.
Trial summary
Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment or the control group for a total of 6 months.All patients will receive cognitive behavioural treatment in groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- antabuse (disulfiram)
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2007to Jun 2009
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcoholism
- Living in the departments catchment area
Who cannot join
- Pregnancy
- Schizophrenia
- Bipolar disorder
- Other substance abuse
- Dementia
- Anorexia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Psykiatrisk Center Gentofte
Hellerup, 2900
Jakob Ulrichsen, MD, ph.d., (45) 3977 3650, jaul@geh.regionh.dk
Jakob Ulrichsen, MD, ph.d.
About this study
Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment or the control group for a total of 6 months.All patients will receive cognitive behavioural treatment in groups. The hypothesis to be tested is that more of the patients who receive antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to the control group. The trial is open.
- Conditions
- Alcoholism
- Being tested
- antabuse (disulfiram)
- Keywords
- alcoholism, antabuse, disulfiram, abstinence, cognitive behavioural therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antabuse (disulfiram)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients in each group who have not been drinking alcohol after 6 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionJun 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Psykiatrisk Center Gentofte
- Sponsor type
- University, hospital or other
- Investigators
- Jakob Ulrichsen, MD, ph.d., Principal investigator, Psykiatrisk Center Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431262
- Sponsor's protocol ID
- EudraCT no. 2006-004921-27
- Status last verified
- Mar 2007
- First submitted
- 1 Feb 2007
- Last updated
- 5 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antabuse in Severe Alcoholism: an Open Controlled Study
- ClinicalTrials.gov ID
- NCT00431262
- Acronym / sponsor ID
- EudraCT no. 2006-004921-27
- Conditions
- Alcoholism
- Keywords
- alcoholism, antabuse, disulfiram, abstinence, cognitive behavioural therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Psykiatrisk Center GentofteUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Jun 2009
- First posted
- 5 Feb 2007 (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.
Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment or the control group for a total of 6 months.All patients will receive cognitive behavioural treatment in groups. The hypothesis to be tested is that more of the patients who receive antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to the control group. The trial is open.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Alcoholism
- Living in the departments catchment area
Key exclusion criteria (6 listed)
- Pregnancy
- Schizophrenia
- Bipolar disorder
- Other substance abuse
- Dementia
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 |
|---|---|---|
| antabuse (disulfiram) | Drug | – |
Primary outcome
The number of patients in each group who have not been drinking alcohol after 6 months of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2007.
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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.
Jakob Ulrichsen, MD, ph.d. principal investigator
Psykiatrisk Center Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antabuse (disulfiram) in people with Alcoholism, run by Psykiatrisk Center Gentofte 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Mar 2007. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients in each group who have not been drinking alcohol after 6 months of treatment.. 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 5 Mar 2007.