Alcohol DependenceNCT02107352
Effect of Anti-craving Medication on Cognitive Functions in Alcohol Dependence: an ERP Study
An observational study of Alcohol Dependence, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The main aim of this research is to investigate whether the use of cognitive event-related potentials is an interesting way to identify subgroups of alcoholic patients displaying specific clinical symptoms and cognitive disturbances in order to help clinicians to adapt the pharmaceutical approach to the specific needs… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2013to 29 Jan 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (age-range 18-65 years) undergoing a three-weeks detoxification cure in Alcohol Unit of CHU Brugmann, diagnosed with alcohol dependence, according to the DSM-IV-TR (diagnostic and statistical manual of mental disorders, 4th revision)
Who may be able to join
- anti-craving medication free at arrival may be included in the study;
- stable doses of antidepressants for two months prior to screening will be permitted
Who cannot join
- participants with a history of neurological disorders, or other serious medical conditions (severe heart, lung, kidney or liver disease), assessed during the intake interview, will be excluded, as well as pregnant women; liver tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT) resulting higher than 5 times the usual values are considered as an exclusion factor due to risk linked to naltrexone consumption;
- patients with current addiction to drugs other than nicotine (assessed through urine screening) will be excluded; individuals with positive cannabis screens will be excluded only if they had a history of cannabis dependence
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this research is to investigate whether the use of cognitive event-related potentials is an interesting way to identify subgroups of alcoholic patients displaying specific clinical symptoms and cognitive disturbances in order to help clinicians to adapt the pharmaceutical approach to the specific needs of the patient.
Nowadays, a fundamental question remains: How can investigators identify among alcoholic patients who are likely to benefit from the use of naltrexone, acamprosate or baclofen, and those who are not? The goal of this application is to identify subgroups of alcoholic patients displaying specific clinical symptoms and cognitive disturbances linked to consistent biological markers. Investigators propose that this might help clinicians improve their treatment of alcoholic patients by focusing therapy on individual cognitive disturbances, and by adapting pharmaceutical approaches to the identified brain pathophysiology. In other words, investigators suggest that specifying the cognitive profile of each individual patient may help clinicians in their choice of a suitable drug program.
To reach this aim, investigators suggest that a joined investigation of early (P100) and late (P300) brain event-related potentials (ERP) components may help create subgroups of alcoholic patients with homogenous cognitive deficits, and that this ''classification'' might help optimize drug treatment. More precisely, investigators suggest that relapse in chronic alcoholism is partly due to (1) the preferential attentional allocation to alcohol-related information (e.g. the sight of a bottle of wine). As the P100 component has already been shown to be enhanced by motivationally relevant stimuli, investigators think that this component is well-suited for this purpose; and (2) the impairment of the inhibitory control, which is necessary to suppress an inappropriate prepotent response. The Go/No-Go task is a simple procedure, which has already proven to be highly reliable to evidence a deficit in inhibitory control processing in alcoholics, indexed by a No-Go P3 of decreased amplitude and less anterior topography. In summary, investigators have two simple experimental procedures, an oddball task and a Go/No-Go task, which can be easily carried out in clinical settings, and which can provide interesting data concerning, respectively, the existence of an implicit attentional bias towards alcohol-cues and the deficit of inhibitory control towards a prepotent response, through the observation of well-known and well-described cognitive ERP components, i.e. the P100 and P3b components. The main goal of this project will be to test the effect of different drug medications on both attentional (P100) and inhibitory (P300) deficits observable in alcoholic patients.
- Conditions
- Alcohol Dependence
- Keywords
- Anti-craving medication, Inhibition, Attentional Bias, Event-Related Potentials, Relapse
- Medical subject headings
- Alcoholism, Inhibition, Psychological, Recurrence
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 |
|---|---|---|
| Naltrexone | 50mg/day | |
| Acamprosate | 1332mg/day if patient weights less than 60 kg, 1998mg/day if patient weights more than 60 kg | |
| Baclofen | 30 mg/day | |
| Placebo | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
P100 and P300 Event-related potentials (ERPs)
Amplitude and latency values of P100 and P300 ERPs between T0 and T1 for each groups of 20 patients to investigate influence of medication (placebo vs. acamprosate vs. naltrexone vs. baclofen).
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start1 Dec 2013
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Campanella, Brugmann University Hospital
- Investigators
- Salvatore Campanella, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107352
- Sponsor's protocol ID
- CHUB-Alcool-Med-Pot Evo
- Status last verified
- Jan 2018
- First submitted
- 10 Dec 2013
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-craving Medication on Cognitive Functions in Alcohol Dependence: an ERP Study
- ClinicalTrials.gov ID
- NCT02107352
- Acronym / sponsor ID
- CHUB-Alcool-Med-Pot Evo
- Conditions
- Alcohol Dependence
- Keywords
- Anti-craving medication, Inhibition, Attentional Bias, Event-Related Potentials, Relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 8 Apr 2014 (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.
The main aim of this research is to investigate whether the use of cognitive event-related potentials is an interesting way to identify subgroups of alcoholic patients displaying specific clinical symptoms and cognitive disturbances in order to help clinicians to adapt the pharmaceutical approach to the specific needs of the patient.
Nowadays, a fundamental question remains: How can investigators identify among alcoholic patients who are likely to benefit from the use of naltrexone, acamprosate or baclofen, and those who are not? The goal of this application is to identify subgroups of alcoholic patients displaying specific clinical symptoms and cognitive disturbances linked to consistent biological markers. Investigators propose that this might help clinicians improve their treatment of alcoholic patients by focusing therapy on individual cognitive disturbances, and by adapting pharmaceutical approaches to the identified brain pathophysiology. In other words, investigators suggest that specifying the cognitive profile of each individual patient may help clinicians in their choice of a suitable drug program.
To reach this aim, investigators suggest that a joined investigation of early (P100) and late (P300) brain event-related potentials (ERP) components may help create subgroups of alcoholic patients with homogenous cognitive deficits, and that this ''classification'' might help optimize drug treatment. More precisely, investigators suggest that relapse in chronic alcoholism is partly due to (1) the preferential attentional allocation to alcohol-related information (e.g. the sight of a bottle of wine). As the P100 component has already been shown to be enhanced by motivationally relevant stimuli, investigators think that this component is well-suited for this purpose; and (2) the impairment of the inhibitory control, which is necessary to suppress an inappropriate prepotent response. The Go/No-Go task is a simple procedure, which has already proven to be highly reliable to evidence a deficit in inhibitory control processing in alcoholics, indexed by a No-Go P3 of decreased amplitude and less anterior topography. In summary, investigators have two simple experimental procedures, an oddball task and a Go/No-Go task, which can be easily carried out in clinical settings, and which can provide interesting data concerning, respectively, the existence of an implicit attentional bias towards alcohol-cues and the deficit of inhibitory control towards a prepotent response, through the observation of well-known and well-described cognitive ERP components, i.e. the P100 and P3b components. The main goal of this project will be to test the effect of different drug medications on both attentional (P100) and inhibitory (P300) deficits observable in alcoholic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | – | –50mg/day |
| Acamprosate | – | –1332mg/day if patient weights less than 60 kg, 1998mg/day if patient weights more than 60 kg |
| Baclofen | – | –30 mg/day |
| Placebo | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (age-range 18-65 years) undergoing a three-weeks detoxification cure in Alcohol Unit of CHU Brugmann, diagnosed with alcohol dependence, according to the DSM-IV-TR (diagnostic and statistical manual of mental disorders, 4th revision)
Key inclusion criteria (2 listed)
- anti-craving medication free at arrival may be included in the study;
- stable doses of antidepressants for two months prior to screening will be permitted
Key exclusion criteria (2 listed)
- participants with a history of neurological disorders, or other serious medical conditions (severe heart, lung, kidney or liver disease), assessed during the intake interview, will be excluded, as well as pregnant women; liver tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT) resulting higher than 5 times the usual values are considered as an exclusion factor due to risk linked to naltrexone consumption;
- patients with current addiction to drugs other than nicotine (assessed through urine screening) will be excluded; individuals with positive cannabis screens will be excluded only if they had a history of cannabis dependence
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
P100 and P300 Event-related potentials (ERPs)
Time frame: up to 20 days
Amplitude and latency values of P100 and P300 ERPs between T0 and T1 for each groups of 20 patients to investigate influence of medication (placebo vs. acamprosate vs. naltrexone vs. baclofen).
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 1 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Salvatore Campanella principal investigator
CHU Brugmann
1 site 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 Brugmann University Hospital at 1 site in Belgium.
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 2 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
P100 and P300 Event-related potentials (ERPs) (time frame: up to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2018.