Individually Adapted Therapy of Alcoholism

Alcoholism Clinical Trial

Official title:

Individually Adapted Therapy of Alcoholism: Clinical Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317031
• Other study ID #: PREDICT
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2006
• Last updated: June 26, 2008
• Start date: November 2002
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics.

Description:

The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics. The secondary objective is to establish an association between patients' motivational type and drug effects. The aim is to improve alcoholism treatment by identifying characteristics for response to specific pharmacological relapse prevention. Such items could allow for an individually adapted pharmacotherapy of alcoholism. Specifically, we will study the possible dependence of the efficacy of naltrexone and/or acamprosate on different motivational types (reward versus relief craving) and genetic profiles referring to glutamatergic and opioidergic candidate genes. Lastly, the longterm costs and cost-effectiveness of the different treatment strategies for alcoholics chosen in our study are established.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Participants will have a current DSM-IV/ICD 10 diagnosis of alcohol dependence.

2. Participants must have had a minimum of 14 drinks (females) or 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and must have had two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence.

3. Participants must have had a minimum of 72 hours of abstinence and no significant withdrawal symptoms (CIWA < 8) prior to randomization.

4. At least 2 weeks of inpatient treatment.

5. Participants can be abstinent for a maximum of 28 days prior to randomization.

6. Participants are willing not to seek additional psychotherapy during the first 6 months of study except attendance of mutual help groups.

7. Participants have to sign a witnessed declaration of informed consent.

Exclusion Criteria:

1. Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder for whom medication is indicated, but no other Axis I disorders that are not medicated and are not severe enough to require medications.

2. Participants who require psychopharmacotherapy.

3. Participants who require therapy with any medications which pose safety issues.

4. Participants with a current abuse of any psychoactive drug and who show a positive drug test on an urine screen.

5. Participants with a lifetime diagnosis of dependence on any psycho-active drug except for nicotine or habitual caffeine use.

6. Participants who have significant medical disorders which would increase the potential risk of the study treatment or interfere with the study participation.

7. Participants with abnormal AST or ALT (more than 5 times the normal level).

8. Participants who are pregnant or nursing infant(s).

9. Women during childbearing years without an effective contraceptive method.

10. Participants developing sensitivity to the study medication.

11. Participants who are illiterate or are unable to read and write German.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Acamprosate or Naltrexone
mg&d 90 days

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Freiburg	Freiburg	BW
Germany	Department of Psychiatry, University of Heidelberg	Heidelberg	BW
Germany	Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health	Mannheim	BW
Germany	Department of Psychiatry, University of Regensburg	Regensburg	Bayern
Germany	Department of Psychiatry, University of Tübingen	Tuebingen	BW

Sponsors (4)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	Dupont Applied Biosciences, German Federal Ministry of Education and Research, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to relapse to heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males)		06/2008	No
Secondary	percentage of days without heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males)		06/2008	No
Secondary	time to first alcohol consumption		06/2008	No
Secondary	percentage of days of complete abstinence from alcohol		06/2008	No