Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent PatientsCEAlcoolNCT05341934
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
A study testing Evaluative Conditionning Task in people with Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients
- What is being tested?
- Evaluative Conditionning Task
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2018to 30 Dec 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in this study will be patients:
- With an alcohol use disorder according to DSM 5
- Follow-up at the Laborit Hospital Center
- Aged between 18 and 70 years with informed consent after receiving written information
- Engaged in a process to reduce alcohol consumption
- With a score of MOCA> 20
- Whose mother tongue is French
- Patients benefiting from social security or benefiting from it through a third party in accordance with the french law on research involving the human person.
Who cannot join
- - Patient with less than 6 Heavy Drinking Days in the month
- Patient with Schizophrenia
- Patient with bipolar disorder Type 1
- Patient with Korsakoff syndrome or degenerative neurological disorder
- Patient with hearing impairment, uncorrected visual impairment
- Patient under curatorship or guardianship
Show all 14Show fewer
- Patient with addiction to another substance other than tobacco
- Patient already enrolled in another interventional study
- Pregnant or nursing woman
- Patient with difficulties of expression or comprehension in French
- Patients in emergency situations or unable to give their consent.
- Output Criteria:
- Patient who has manifested verbally or in writing, the desire to leave the study in progress.
- Patient who will be hospitalized during the study for a problem related to his addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
- Being tested
- Evaluative Conditionning Task
- Keywords
- evaluative conditionning, addiction, alcohol, patients
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluative Conditionning TaskOther
Also called Implicit Association Task, Subliminal Attitude Misattribution Procedure
A word will appear in one of the four quadrants on the computer screen. They will have to answer the word as quickly as possible by pressing the space bar. They will also be told that an image will be displayed briefly (400 ms) in the same quadrant by pressing the answer key. This procedure will be repeated for 120 trials: 30 trials with alcohol-related Conditional Stimulus (CS), 30 trials with CS related to non-alcoholic beverages and 60 trials with the CS of filling. The CS referring to alcohol will be the words Beer, Wine …; The CS referring to soft drinks will be the words Coca-Cola, Fanta… and Filling CS referring to vegetables and fruits will be: Apple, Banana…In experimental conditions, alcohol-related CS will be followed by negative Unconditional Stimuli (US) (images from the International Affective Picture System (Lang, Bradley, \& Cuthbert, 1997)), CS referring to soft drinks linked to positive images and CS referring to fruits and vegetables will be linked to neutral US.
| Study group | Role | What they receive |
|---|---|---|
| Conditionning | Active comparator | Not described Receives: Other: Evaluative Conditionning Task |
| Placebo | Placebo comparator | Not described Receives: Other: Evaluative Conditionning Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction of automatic or implicit associations of Alcohol with positive affect.
It will be evaluated by calculating the difference between the scores of the IAT task before and after the Evaluative Conditioning.
Measured: baseline
Secondary outcomes (2)
The reduction in the total amount of alcohol consumed
The reduction in the total amount of alcohol consumed (TAC: Total Alcohol Consumption) as well as the number of Heavy Drinking Day (HDD) over the 12-week period following treatment, with respect to the baseline time.
The baseline time is the week before randomization. Consumption of alcohol (total quantity and consumption habits) during this period will be considered as a baseline.
The HDD corresponds to the days of consumption of more than 60 grams of pure alcohol (men) or 40 grams (women).
Measured: week 2
The reduction in the total amount of alcohol consumed
The reduction in the total amount of alcohol consumed (TAC: Total Alcohol Consumption) as well as the number of Heavy Drinking Day (HDD) over the 12-week period following treatment, with respect to the baseline time.
The baseline time is the week before randomization. Consumption of alcohol (total quantity and consumption habits) during this period will be considered as a baseline.
The HDD corresponds to the days of consumption of more than 60 grams of pure alcohol (men) or 40 grams (women).
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start15 Jan 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Why it stopped: No Inclusion/ Study never begin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent PatientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JAAFARI NEMATOLLAH, PROFESSOR, Principal investigator, Centre Hospitalier Henri Laborit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341934
- Sponsor's protocol ID
- 2017-A02120-53
- Acronym
- CEAlcool
- Status last verified
- Apr 2022
- First submitted
- 15 Jul 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
- ClinicalTrials.gov ID
- NCT05341934
- Acronym / sponsor ID
- CEAlcool / 2017-A02120-53
- Keywords
- evaluative conditionning, addiction, alcohol, patients
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Inclusion/ Study never begin
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 22 Apr 2022 (actual)
- 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.
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditionning | Active comparator | Other: Evaluative Conditionning Task |
| Placebo | Placebo comparator | Other: Evaluative Conditionning Task |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants in this study will be patients:
- With an alcohol use disorder according to DSM 5
- Follow-up at the Laborit Hospital Center
- Aged between 18 and 70 years with informed consent after receiving written information
- Engaged in a process to reduce alcohol consumption
Key exclusion criteria (14 listed)
- - Patient with less than 6 Heavy Drinking Days in the month
- Patient with Schizophrenia
- Patient with bipolar disorder Type 1
- Patient with Korsakoff syndrome or degenerative neurological disorder
- Patient with hearing impairment, uncorrected visual impairment
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 |
|---|---|---|
| Evaluative Conditionning TaskAlso: Implicit Association Task, Subliminal Attitude Misattribution ProcedureA word will appear in one of the four quadrants on the computer screen. They will have to answer the word as quickly as possible by pressing the space bar. They will also be told that an image will be displayed briefly (400 ms) in the same quadrant by pressing the answer key. This procedure will be repeated for 120 trials: 30 trials with alcohol-related Conditional Stimulus (CS), 30 trials with CS related to non-alcoholic beverages and 60 trials with the CS of filling. The CS referring to alcohol will be the words Beer, Wine …; The CS referring to soft drinks will be the words Coca-Cola, Fanta… and Filling CS referring to vegetables and fruits will be: Apple, Banana…In experimental conditions, alcohol-related CS will be followed by negative Unconditional Stimuli (US) (images from the International Affective Picture System (Lang, Bradley, \& Cuthbert, 1997)), CS referring to soft drinks linked to positive images and CS referring to fruits and vegetables will be linked to neutral US. | Other | Conditionning, Placebo |
Primary outcome
The reduction of automatic or implicit associations of Alcohol with positive affect.
Time frame: baseline
It will be evaluated by calculating the difference between the scores of the IAT task before and after the Evaluative Conditioning.
2 secondary outcomes
The reduction in the total amount of alcohol consumed
Time frame: week 2
The reduction in the total amount of alcohol consumed
Time frame: month 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: Undecided
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.
JAAFARI NEMATOLLAH, PROFESSOR principal investigator
Centre Hospitalier Henri Laborit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluative Conditionning Task in people with Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients, run by Centre Hospitalier Henri Laborit at 1 site 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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 22 Apr 2022. 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 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
The reduction of automatic or implicit associations of Alcohol with positive affect. (time frame: baseline). 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 22 Apr 2022.