Antabuse in Severe Alcoholism: an Open Controlled Study | NCT00431262

Studies
Antabuse in Severe Alcoholism: an Open Controlled Study

NCT00431262

Sponsor

Psykiatrisk Center Gentofte

Status

Unknown status

Last Update Posted

Mar 5, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Alcoholism

Interventions

antabuse (disulfiram)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Not provided

Completion Date

Jun 2009

First Submitted Date

Feb 1, 2007

First Submission Date that Met QC Criteria

Feb 1, 2007

First Posted Date

Feb 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2007

Last Update Posted Date

Mar 5, 2007Estimated

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
antabuse (disulfiram)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients in each group who have not been drinking alcohol after 6 months of treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Alcoholism
Living in the departments catchment area

Exclusion Criteria:

Pregnancy
Schizophrenia
Bipolar disorder
Other substance abuse
Dementia
Anorexia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jakob Ulrichsen, MD, ph.d.	Psykiatrisk Center Gentofte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psykiatrisk Center Gentofte	Recruiting	Hellerup		2900	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004221	Disulfiram

Ancestor Terms

ID	Term
D004050	Ditiocarb
D013859	Thiocarbamates
D002219	Carbamates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided