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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01491347
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Philippe Nubukpo, Centre Hospitalier Esquirol

Brief Summary:

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 or disease
Alcohol Dependence

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).

Study Type : Observational
Actual Enrollment : 389 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

alcohol dependent

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01491347

Clinique Saint Maurice
La Jonchère, France, 87340
Centre Hospitalier Esquirol
Limoges, France, 87000
Centre Hospitalier de Vauclaire
Montpon Menesterol, France, 24700
Centre Hospitalier La Vallette
Saint-Vaury, France, 23300
Sponsors and Collaborators
Centre Hospitalier Esquirol
Principal Investigator: Philippe Nubukpo, MD, PhD Centre Hospitalier Esquirol

Responsible Party: Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol Identifier: NCT01491347     History of Changes
Other Study ID Numbers: 2011-A00452-39
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Philippe Nubukpo, Centre Hospitalier Esquirol:

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs