Alcohol Use DisorderREALNCT02881983
Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients
An observational study of Alcohol Use Disorder, run by University Hospital, Lille at 2 sites in France.
Trial summary
Background: Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- the presentation of pictures (static stimuli) or videos (dynamic stimuli)
- How many people
- 112 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2014to Apr 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Short term alcohol abstinent patients (STA, after 1month of withdrawal) * Long-term alcohol abstinent individuals (at least six months of abstinence) * Healthy control participants (C)
Who may be able to join
- For STA and LTA groups :
- a diagnosis of severe alcohol use disorder (DSM5 criteria, 2013 confirmed by an addictonologist and a psychologist),
- successful completion of withdrawal,
- an intended treatment length of at least 1 month (for the STA group) or at least 6 months (for the LTA group).
- For Control participants (C) :
- social drinkers, and were recruited from the general population (e.g. at the university).
Who cannot join
- with delusional psychiatric disorders (and/or medication for psychiatric disorders (excepted anxiolytics),
- neurological or cardiological disorders,
- taking medication that may act on heart rate or alter the regulation of body temperature or cognitive functions,
- with active co-dependence (except for tobacco)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of Mechanisms of Emotion Regulation in Short- and Long-term Alcohol-abstinent Patients
Background:
Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy control participants (C) in a positive and negative emotion induction protocol.
Read more
Main aim:
Evaluating the emotional regulation deficits assessed with physiological indicators (heart rate variability, electrodermal response, pupil diameter) and clinically in presentations of visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's (AUD) patients with short and long term abstinent compared to a control group of healthy subjects. The investigators are particularly interested in the evolution of heart rate variability considered as a good marker of vulnerability to AUD.
Secondary objectives:
Studying the relationships between physiological measures and clinical variables such as behavioral indicators and self-reported assessment of cognitive and emotional skills among the three groups (STA, LTA and C).
Read the detailed description
The recording was performed for all participants during presentation of high emotional inducing stimuli presenting human interactions (pictures and video sequences). For each participant physiological responses (pupil diameter, heart rate, and skin conductance) were recorded before, during and after induction.
Participants were asked to evaluate the intensity and the valence of emotional stimuli.
In addition, a neurological evaluation, a clinical and cognitive assessment were performed.
Neurological, clinical and cognitive evaluation - Each participant had a clinical structured interview, a neurological evaluation, self-administered assessment (Hospital Anxiety \& Depression Scale, Emotional Skills Profile, Obsessive Compulsive Drinking Scale, and cognitive assessment (Montreal Cognitive Assessment).
Physiological assessment - The recording was performed for all participants during the presentation of pictures (static stimuli) or videos (dynamic stimuli) selected according to their high emotional intensity (positive, neutral and negative valence), representing human interactions. For each participant heart rate, electrodermal activity, and pupil diameter were recorded during three experimental conditions: rest, induction (presentation of stimuli) and after induction (recovery). Participants were asked to evaluate the intensity and valence of the pictures and videos using the Self-Assessment Manikin.
- Conditions
- Alcohol Use Disorder
- Being tested
- the presentation of pictures (static stimuli) or videos (dynamic stimuli)
- Keywords
- alcohol use disorder, emotion processing, abstinence, sympathetic system, parasympathetic system
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the presentation of pictures (static stimuli) or videos (dynamic stimuli)Other
| Study group | Role | What they receive |
|---|---|---|
| STA group | Short-term alcohol abstinent patients (after 1 month of withdrawal) Receives: Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli) | |
| LTA group | Long-term alcohol abstinent patients (at least 6 months of abstinence) Receives: Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli) | |
| Control group | Healthy subjects Receives: Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
High measuring heart rate
Measured: 3 years
Secondary outcomes (4)
Electrodermal response
skin conductance
Measured: 3 years
pupil diameter
pupil diameter
Measured: 3 years
HAD score
Score at the Hospital Anxiety \& Depression Scale
Measured: 3 years
MocA assessment
Montréal cognitive Assessement score
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier COTTENCIN, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881983
- Sponsor's protocol ID
- 2013_31
- Other IDs
- 2014-A00105-42
- Acronym
- REAL
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2016
- Last updated
- 25 Aug 2017
- 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 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Mechanisms of Emotion Regulation in Short- and Long-term Alcohol-abstinent Patients
- ClinicalTrials.gov ID
- NCT02881983
- Acronym / sponsor ID
- REAL / 2013_31
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol use disorder, emotion processing, abstinence, sympathetic system, parasympathetic system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Aug 2016 (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.
Background:
Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy control participants (C) in a positive and negative emotion induction protocol.
Main aim:
Evaluating the emotional regulation deficits assessed with physiological indicators (heart rate variability, electrodermal response, pupil diameter) and clinically in presentations of visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's (AUD) patients with short and long term abstinent compared to a control group of healthy subjects. The investigators are particularly interested in the evolution of heart rate variability considered as a good marker of vulnerability to AUD.
Secondary objectives:
Studying the relationships between physiological measures and clinical variables such as behavioral indicators and self-reported assessment of cognitive and emotional skills among the three groups (STA, LTA and C).
Detailed description
The recording was performed for all participants during presentation of high emotional inducing stimuli presenting human interactions (pictures and video sequences). For each participant physiological responses (pupil diameter, heart rate, and skin conductance) were recorded before, during and after induction.
Participants were asked to evaluate the intensity and the valence of emotional stimuli.
In addition, a neurological evaluation, a clinical and cognitive assessment were performed.
Neurological, clinical and cognitive evaluation - Each participant had a clinical structured interview, a neurological evaluation, self-administered assessment (Hospital Anxiety \& Depression Scale, Emotional Skills Profile, Obsessive Compulsive Drinking Scale, and cognitive assessment (Montreal Cognitive Assessment).
Physiological assessment - The recording was performed for all participants during the presentation of pictures (static stimuli) or videos (dynamic stimuli) selected according to their high emotional intensity (positive, neutral and negative valence), representing human interactions. For each participant heart rate, electrodermal activity, and pupil diameter were recorded during three experimental conditions: rest, induction (presentation of stimuli) and after induction (recovery). Participants were asked to evaluate the intensity and valence of the pictures and videos using the Self-Assessment Manikin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STA group | – | Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)Short-term alcohol abstinent patients (after 1 month of withdrawal) |
| LTA group | – | Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)Long-term alcohol abstinent patients (at least 6 months of abstinence) |
| Control group | – | Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)Healthy subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Short term alcohol abstinent patients (STA, after 1month of withdrawal) * Long-term alcohol abstinent individuals (at least six months of abstinence) * Healthy control participants (C)
Key inclusion criteria (6 listed)
- a diagnosis of severe alcohol use disorder (DSM5 criteria, 2013 confirmed by an addictonologist and a psychologist),
- successful completion of withdrawal,
- an intended treatment length of at least 1 month (for the STA group) or at least 6 months (for the LTA group).
- social drinkers, and were recruited from the general population (e.g. at the university).
Key exclusion criteria (4 listed)
- with delusional psychiatric disorders (and/or medication for psychiatric disorders (excepted anxiolytics),
- neurological or cardiological disorders,
- taking medication that may act on heart rate or alter the regulation of body temperature or cognitive functions,
- with active co-dependence (except for tobacco)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the presentation of pictures (static stimuli) or videos (dynamic stimuli) | Other | Control group, LTA group, STA group |
Primary outcome
Heart Rate Variability
Time frame: 3 years
High measuring heart rate
4 secondary outcomes
Electrodermal response
Time frame: 3 years
pupil diameter
Time frame: 3 years
HAD score
Time frame: 3 years
MocA assessment
Time frame: 3 years
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 25 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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.
Olivier COTTENCIN, MD, PhD principal investigator
University Hospital, Lille
2 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 Use Disorder, run by University Hospital, Lille at 2 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 6 inclusion and 4 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 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Heart Rate Variability (time frame: 3 years). 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 25 Aug 2017.