AlcoholismPhase 4NCT00159107
Integrative Therapy in Alcoholism
A Phase 4 study testing Acamprosate and Integrative behavior therapy in people with Alcoholism, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Acamprosate and Integrative behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 371 participants
- Where
- 1 siteGermany
- Study dates
- May 2003to Dec 2006
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSMIV criteria of alcoholism
- Age between 25 and 60
- Informed consent
Who cannot join
- Residence outside of the catchment area
- Legal reasons
- Insufficient knowledge of the German language
- Substance abuse or addiction other than alcohol or nicotine
- Pregnancy
- Serious physical illness
- Organic brain disease
- Contraindication to Acamprosate treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
Düsseldorf, North Rhine-Westfalia, 40629
About this study
Official title: Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents
The main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.
Read the detailed description
The objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. This investigation should contribute to the issue of effective relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy + Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate. Follow-up examinations carried out 3 and 6 months after the end of treatment.
- Conditions
- Alcoholism
- Being tested
- Acamprosate, Integrative behavior therapy, Placebo
- Keywords
- alcoholism, abstinence enhancement, psychotherapy, cognitive behavior therapy vs. supportive counseling, Acamprosate vs. Placebo, multi-center study
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
Acamprosate
Integrative behavior therapyBehavioural
Integrative behavior therapy
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Placebo +Integrative behavior therapy Receives: Behavioral: Integrative behavior therapy; Drug: Placebo |
| 3 | Experimental | Acamprosate + treatment as usual Receives: Drug: Acamprosate |
| 1 | Experimental | Acamprosate + Integrative behavior therapy Receives: Drug: Acamprosate; Behavioral: Integrative behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence
Measured: 3,6,12 months
Secondary outcomes (2)
Social functioning
Measured: 12 months
Cognitive functioning
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2003
- Study completionDec 2006
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Addiction Research Network, Merck Sharp & Dohme LLC, University of Bonn, Universität Duisburg-Essen, University of Homburg, Psychosomatic Clinic of Bergisch Gladbach
- Investigators
- Wolfgang Gaebel, Professor, Study chair, Department of Psychiatry and Psychotherapy, University of Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159107
- Sponsor's protocol ID
- 01EB0133
- Status last verified
- Oct 2007
- First submitted
- 7 Sep 2005
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents
- ClinicalTrials.gov ID
- NCT00159107
- Acronym / sponsor ID
- 01EB0133
- Conditions
- Alcoholism
- Keywords
- alcoholism, abstinence enhancement, psychotherapy, cognitive behavior therapy vs. supportive counseling, Acamprosate vs. Placebo, multi-center study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Addiction Research Network, Merck Sharp & Dohme LLC, University of Bonn, Universität Duisburg-Essen, University of Homburg, Psychosomatic Clinic of Bergisch Gladbach
- Study start
- May 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Sep 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 main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.
Detailed description
The objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. This investigation should contribute to the issue of effective relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy + Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate. Follow-up examinations carried out 3 and 6 months after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Behavioral: Integrative behavior therapy, Drug: PlaceboPlacebo +Integrative behavior therapy |
| 3 | Experimental | Drug: AcamprosateAcamprosate + treatment as usual |
| 1 | Experimental | Drug: Acamprosate, Behavioral: Integrative behavior therapyAcamprosate + Integrative behavior therapy |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSMIV criteria of alcoholism
- Age between 25 and 60
- Informed consent
Key exclusion criteria (8 listed)
- Residence outside of the catchment area
- Legal reasons
- Insufficient knowledge of the German language
- Substance abuse or addiction other than alcohol or nicotine
- Pregnancy
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 |
|---|---|---|
| AcamprosateAcamprosate | Drug | 1, 3 |
| Integrative behavior therapyIntegrative behavior therapy | Behavioural | 1, 2 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Abstinence
Time frame: 3,6,12 months
2 secondary outcomes
Social functioning
Time frame: 12 months
Cognitive functioning
Time frame: 12 months
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 30 Jan 2008.
Related trials for Alcoholism
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
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.
Wolfgang Gaebel, Professor study chair
Department of Psychiatry and Psychotherapy, University of Düsseldorf
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 Acamprosate and Integrative behavior therapy in people with Alcoholism, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 3 inclusion and 8 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 30 Jan 2008. 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 Germany. 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?
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?
Abstinence (time frame: 3,6,12 months). 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 30 Jan 2008.