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AlcoholismPhase 4NCT00317031

Individually Adapted Therapy of Alcoholism

A Phase 4 study testing Acamprosate or Naltrexone in people with Alcoholism, run by Central Institute of Mental Health, Mannheim at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcoholism
What is being tested?
Acamprosate or Naltrexone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
435 participants
Where
5 sitesGermany
Study dates
Nov 2002to Jun 2008
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants will have a current DSM-IV/ICD 10 diagnosis of alcohol dependence.
  • 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.
  • Participants must have had a minimum of 72 hours of abstinence and no significant withdrawal symptoms (CIWA < 8) prior to randomization.
  • At least 2 weeks of inpatient treatment.
  • Participants can be abstinent for a maximum of 28 days prior to randomization.
  • Participants are willing not to seek additional psychotherapy during the first 6 months of study except attendance of mutual help groups.
  • Participants have to sign a witnessed declaration of informed consent.

Who cannot join

  • 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.
  • Participants who require psychopharmacotherapy.
  • Participants who require therapy with any medications which pose safety issues.
  • Participants with a current abuse of any psychoactive drug and who show a positive drug test on an urine screen.
  • Participants with a lifetime diagnosis of dependence on any psycho-active drug except for nicotine or habitual caffeine use.
  • Participants who have significant medical disorders which would increase the potential risk of the study treatment or interfere with the study participation.
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  • Participants with abnormal AST or ALT (more than 5 times the normal level).
  • Participants who are pregnant or nursing infant(s).
  • Women during childbearing years without an effective contraceptive method.
  • Participants developing sensitivity to the study medication.
  • Participants who are illiterate or are unable to read and write German.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Department of Psychiatry, University of Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79104

  • Department of Psychiatry, University of Heidelberg

    Heidelberg, Baden-Wurttemberg, 69115

  • Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health

    Mannheim, Baden-Wurttemberg, 68159

  • Department of Psychiatry, University of Regensburg

    Regensburg, Bavaria, 93053

  • Department of Psychiatry, University of Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

Official title: Individually Adapted Therapy of Alcoholism: Clinical Studies

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

Read the detailed 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.

Conditions
Alcoholism
Being tested
Acamprosate or Naltrexone
Keywords
Alcoholism, Drug Therapy
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acamprosate or NaltrexoneDrug

    mg\&d 90 days

Study groups in NCT00317031
Study groupRoleWhat they receive
1Active comparatorAcamprosate
Receives: Drug: Acamprosate or Naltrexone
2Active comparatorNaltrexone
Receives: Drug: Acamprosate or Naltrexone
3Placebo comparatorPlacebo
Receives: Drug: Acamprosate or Naltrexone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 06/2008

Secondary outcomes (3)

  1. 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)

    Measured: 06/2008

  2. time to first alcohol consumption

    Measured: 06/2008

  3. percentage of days of complete abstinence from alcohol

    Measured: 06/2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2006 (estimated)
  2. Study startNov 2002
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317031
Sponsor's protocol ID
PREDICT
Status last verified
Jun 2008
First submitted
19 Apr 2006
Last updated
27 Jun 2008
Results posted
No

Publications

  • Reinhard I, Lemenager T, Fauth-Buhler M, Hermann D, Hoffmann S, Heinz A, Kiefer F, Smolka MN, Wellek S, Mann K, Vollstadt-Klein S. A comparison of region-of-interest measures for extracting whole brain data using survival analysis in alcoholism as an example. J Neurosci Methods. 2015 Mar 15;242:58-64. doi: 10.1016/j.jneumeth.2015.01.001. Epub 2015 Jan 12.

    PubMed 25593047

  • Mann K, Vollstadt-Klein S, Reinhard I, Lemenager T, Fauth-Buhler M, Hermann D, Hoffmann S, Zimmermann US, Kiefer F, Heinz A, Smolka MN. Predicting naltrexone response in alcohol-dependent patients: the contribution of functional magnetic resonance imaging. Alcohol Clin Exp Res. 2014 Nov;38(11):2754-62. doi: 10.1111/acer.12546.

    PubMed 25421512

  • Lemenager T, Hill H, Reinhard I, Hoffmann S, Zimmermann US, Hermann D, Smolka MN, Kiefer F, Vollstadt-Klein S, Heinz A, Mann K. Association between alcohol-cue modulated startle reactions and drinking behaviour in alcohol dependent patients - results of the PREDICT study. Int J Psychophysiol. 2014 Dec;94(3):263-71. doi: 10.1016/j.ijpsycho.2014.09.009. Epub 2014 Sep 28.

    PubMed 25269022

  • Mann K, Lemenager T, Hoffmann S, Reinhard I, Hermann D, Batra A, Berner M, Wodarz N, Heinz A, Smolka MN, Zimmermann US, Wellek S, Kiefer F, Anton RF; PREDICT Study Team. Results of a double-blind, placebo-controlled pharmacotherapy trial in alcoholism conducted in Germany and comparison with the US COMBINE study. Addict Biol. 2013 Nov;18(6):937-46. doi: 10.1111/adb.12012. Epub 2012 Dec 12.

    PubMed 23231446

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acamprosate or Naltrexone in people with Alcoholism, run by Central Institute of Mental Health, Mannheim at 5 sites 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 7 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 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?

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) (time frame: 06/2008). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317031, which also lists 4 linked publications.

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 27 Jun 2008.

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