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

Alcohol Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491347
• Other study ID #: 2011-A00452-39
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: January 30, 2017
• Start date: November 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Esquirol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Locations

Country	Name	City	State
France	Clinique Saint Maurice	La Jonchère
France	Centre Hospitalier Esquirol	Limoges
France	Centre Hospitalier de Vauclaire	Montpon Menesterol
France	Centre Hospitalier La Vallette	Saint-Vaury

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Esquirol

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDNF serum levels variations between alcohol withdrawal and 14-, 28- days, 2-, 4- and 6- months after in relation to abstinence at 6 months.		6 months
Secondary	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.		6 months
Secondary	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.		6 months