Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre Hospitalier Esquirol
Sponsor:
Information provided by (Responsible Party):
Philippe Nubukpo, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier:
NCT01491347
First received: December 12, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

Alcohol dependence is accompanied by several neurological mechanisms involving neuronal plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF) synthesis.

The investigators found that serum BDNF levels in alcohol-dependent subjects increased to a greater extent in subjects who had remained abstinent at 6 months after withdrawal than in subjects who had relapse.

To verify if the BDNF serum levels variation is linked to the way that abstinence is installed, wthe investigators will measure BDNF serum levels in alcohol dependent subjects at the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its evolution in relation to alcohol consumption, and other clinical characteristics : depression intensity, anxiety, alcohol craving, biological markers of alcohol consumption or toxicity. Monitoring serum BDNF concentrations in link with other clinical data could help to characterize alcohol dependence profiles in clinical practice, help predict relapses, and assist in adjusting care to prevent difficulties in alcohol withdrawal.


Condition
Alcohol Dependence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months Following After Alcohol Withdrawal in Alcohol-dependent Subjects in Relation to Abstinence

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Esquirol:

Primary Outcome Measures:
  • BDNF serum levels variations between alcohol withdrawal and 14-, 28- days, 2-, 4- and 6- months after in relation to abstinence at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Search of a correlation between serum BDNF levels and alcohol consumption marker (CDT), GGT, EtG at 28 days 2, 4, and 6 months after alcohol withdrawal. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Search of a correlation between serum BDNF levels and the scores to psychometric scales : BDI, MADRS, HAM-A, OCDS, at 28 days 2, 4, and 6 months after alcohol withdrawal. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 389
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
alcohol dependent

Detailed Description:

A total of 205 patients will be recruited at their hospitalization time for alcohol withdrawal during a 18 months period. The follow-up at 14, 28 days, 2, 4, 6 months after alcohol withdrawal will assess their BDNF serum levels, the levels of carbohydrate deficient transferrin (CDT), gamma glutamyl transferase (GGT), urinary ethylglucuronide (EtG), and the scores to the Beck Depression Inventory (BDI), the Montgomery Asberg depression scale (MADRS), the Hamilton'anxiety scale (HAM-A), the Obsessive Compulsive Drinking Scale (OCDS).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with alcohol dependance diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), and asking for alcohol withdrawal in hospitalization

Criteria

Inclusion Criteria:

  • Diagnosis of alcohol dependence according to the DSM-IV-TR
  • Request for withdrawal

Exclusion Criteria:

  • Age < 18 years
  • Psychiatric co-morbidity in an evoluting stage and predominant on the addiction trouble
  • Characterized (diagnosed) neurological co-morbidity
  • Severe somatic pathology and / or with fatal predicted outcome in the year (cancer...)
  • Inability to answer the questionnaires
  • pregnancy
  • neuroleptic or antidepressant treatment established for less than 3 months
  • anti-retroviral treatment
  • absence of consent, judiciary protection, hospitalization under constraint, - absence of health insurance.
  • Residence at more than 80 km from the study center
  • Participation to an other biomedical study during the 6 months of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491347

Contacts
Contact: Philippe Nubukpo, MD, PhD 0033555431374 philippe.nubukpo@ch-esquirol-limoges.fr
Contact: Murielle Girard, PhD 0033555431100 murielle.girard@ch-esquirol-limoges.fr

Locations
France
Clinique Saint Maurice Recruiting
La Jonchère, France, 87340
Contact: Denis Schadler, MD    0033555395959    denis.schadler@wanadoo.fr   
Principal Investigator: Denis Schadler, MD         
Centre Hospitalier Esquirol Recruiting
Limoges, France, 87000
Contact: Philippe Nubukpo, MD, PhD    0033555431374    philippe.nubukpo@ch-esquirol-limoges.fr   
Contact: Murielle Girard, PhD    0033555431100    murielle.girard@ch-esquirol-limoges.fr   
Centre Hospitalier de Vauclaire Recruiting
Montpon Menesterol, France, 24700
Contact: Pierre-Louis Diennet, MD    0033553056680    pierre-louis.diennet@ch-montpon.fr   
Principal Investigator: Pierre-Louis Diennet, MD         
Centre Hospitalier La Vallette Not yet recruiting
Saint-Vaury, France, 23300
Contact: Philippe Nubukpo, MD, PhD    05 55 51 77 00      
Principal Investigator: Philippe Nubukpo, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Esquirol
Investigators
Principal Investigator: Philippe Nubukpo, MD, PhD Centre Hospitalier Esquirol
  More Information

Publications:
Responsible Party: Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01491347     History of Changes
Other Study ID Numbers: 2011-A00452-39
Study First Received: December 12, 2011
Last Updated: May 13, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Esquirol:
BDNF
withdrawal
alcohol
psychiatry

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014