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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Saint Maurice, La Jonchère, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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
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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Esquirol

Other

Registry information

Official study title

Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months Following After Alcohol Withdrawal in Alcohol-dependent Subjects in Relation to Abstinence

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Dec 14, 2011
Registry last updated: Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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