NCT02881983

Brief 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 (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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

August 24, 2016

Last Update Submit

August 24, 2017

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorderemotion processingabstinencesympathetic systemparasympathetic system

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability

    High measuring heart rate

    3 years

Secondary Outcomes (4)

  • Electrodermal response

    3 years

  • pupil diameter

    3 years

  • HAD score

    3 years

  • MocA assessment

    3 years

Study Arms (3)

STA group

Short-term alcohol abstinent patients (after 1 month of withdrawal)

Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)

LTA group

Long-term alcohol abstinent patients (at least 6 months of abstinence)

Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)

Control group

Healthy subjects

Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)

Interventions

the presentation of pictures (static stimuli) or videos (dynamic stimuli)OTHER
Control groupLTA groupSTA group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CSAPA

Lille, 59037, France

Location

CHRU Lille, Fontan2

Lille, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Olivier COTTENCIN, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

April 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)