NCT01491347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

5.1 years

First QC Date

December 12, 2011

Last Update Submit

January 30, 2017

Conditions

Alcohol Dependence

Keywords

BDNFwithdrawalalcoholpsychiatry

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (1)

alcohol dependent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinique Saint Maurice

La Jonchère, 87340, France

Location

Centre Hospitalier Esquirol

Limoges, 87000, France

Location

Centre Hospitalier de Vauclaire

Montpon-Ménestérol, 24700, France

Location

Centre Hospitalier La Vallette

Saint-Vaury, 23300, France

Location

Related Publications (2)

  • 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.

    PMID: 21848960BACKGROUND

  • 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.

    PMID: 33438862DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Philippe Nubukpo, MD, PhD

    Centre Hospitalier Esquirol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

FR(4)