Alcohol DependenceNCT01491347
Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal
An observational study of Alcohol Dependence, run by Centre Hospitalier Esquirol at 4 sites in France.
Trial summary
Alcohol dependence is accompanied by several neurological mechanisms involving neuronal plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF) synthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- How many people
- 389 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Diagnosis of alcohol dependence according to the DSM-IV-TR
- Request for withdrawal
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinique Saint Maurice
La Jonchère, 87340
Centre Hospitalier Esquirol
Limoges, 87000
Centre Hospitalier de Vauclaire
Montpon-Ménestérol, 24700
Centre Hospitalier La Vallette
Saint-Vaury, 23300
About this study
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
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.
Read the 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).
- Conditions
- Alcohol Dependence
- Keywords
- BDNF, withdrawal, alcohol, psychiatry
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| alcohol dependent | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF serum levels variations between alcohol withdrawal and 14-, 28- days, 2-, 4- and 6- months after in relation to abstinence at 6 months.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Nubukpo, Centre Hospitalier Esquirol
- Investigators
- Philippe Nubukpo, MD, PhD, Principal investigator, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491347
- Sponsor's protocol ID
- 2011-A00452-39
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2011
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21848960Pareaud 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.
PubMed 33438862
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01491347
- Acronym / sponsor ID
- 2011-A00452-39
- Conditions
- Alcohol Dependence
- Keywords
- BDNF, withdrawal, alcohol, psychiatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alcohol dependent | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Diagnosis of alcohol dependence according to the DSM-IV-TR
- Request for withdrawal
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Background: PubMed 21848960Costa 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.
- Derived from this study: PubMed 33438862Pareaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Nubukpo, MD, PhD principal investigator
Centre Hospitalier Esquirol
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Dependence, run by Centre Hospitalier Esquirol at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01491347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.