Clinical trial NCT01491347: Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Dependence
Keywords: BDNF
withdrawal
alcohol
psychiatry
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: BDNF serum levels variations between alcohol withdrawal and 14-, 28- days, 2-, 4- and 6- months after in relation to abstinence at 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: La Jonchère
country: France
facility: Clinique Saint Maurice
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
city: Montpon Menesterol
country: France
facility: Centre Hospitalier de Vauclaire
city: Saint-Vaury
country: France
facility: Centre Hospitalier La Vallette
Study officials:
affiliation: Centre Hospitalier Esquirol
name: Philippe Nubukpo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa MA, Girard M, Dalmay F, Malauzat D. Brain-derived neurotrophic factor serum levels in alcohol-dependent subjects 6 months after alcohol withdrawal. Alcohol Clin Exp Res. 2011 Nov;35(11):1966-73. doi: 10.1111/j.1530-0277.2011.01548.x. Epub 2011 Aug 16.
citation: Pareaud M, Girard M, Nubukpo P. Factors for Maintaining Abstinence at 2 and 6 Months After Alcohol Withdrawal. J Psychiatr Pract. 2021 Jan 21;27(1):2-13. doi: 10.1097/PRA.0000000000000522.