Alcohol Use DisorderIMMANENCENCT06618755
Motivational Interviews Post Hospitalisation on Maintaining AbstiNence for 1 Year après le Sevrage en Alcool
A study of Alcohol Use Disorder and Addiction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Addiction, Alcohol Withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2024to 13 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- With alcohol use disorders defined by at least 2 DSM-V criteria for at least 12 months).
- Being treated for withdrawal in hospital.
- With a goal of complete abstinence.
- With a means of communication (telephone).
Who cannot join
- Lack of understanding (written and spoken) of the French language.
- Breach of HC withdrawal contract, following failure to comply with the rules of the addictology service and somatic complications of addiction.
- Eviction from the department, discharge against medical advice during hospitalisation for withdrawal.
- Proven cognitive problems compromising understanding of the implications of the study and the proposed follow-up. proposed follow-up.
- Serious decompensated somatic pathology.
- Non-membership or non-beneficiaries of a national health insurance scheme.
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- Person protected by law, under guardianship or curatorship.
- Not having signed free and informed consent to participate in the research.
- Simultaneous participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas RISDORFER DE ISSDENTZI contact
France1 site, 1 recruiting
- Recruiting
Thomas RISDORFER DE ISSDENTZI
Montpellier, 3400
Thomas RISDORFER DE ISSDENTZI, 04 67 33 70 20, t-risdorferdeissdentzi@chu-montpellier.fr
About this study
Official title: IMMANENCE - Intérêt d'un Suivi Sous Forme d'Entretiens Motivationnels spécifiques Post Hospitalisation Sur le Maintien de l'AbstiNENCE Durant l'année Suivant le Sevrage en Alcool
The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. The hypothesis is that reinforced post-withdrawal follow-up, of the motivational interview type, during the first 4 months following hospitalisation, in addition to the usual care, would allow :
- Increase the percentage of days of abstinence in the year following withdrawal.
- Reduce the rate of relapse in the year following withdrawal.
- An increase in the cumulative and maximum duration of abstinence, an increase in motivation to maintain the change initiated and a reduction in the use of other substances in the year following withdrawal.
- A reduction in the impact of risk factors involved in the relapse process in the year following withdrawal.
All participants will have assessments to monitor their abstinence and consumption. In addition to their assessments, the experimental group will have motivational talks once every 15 days.
Read the detailed description
In Europe, and particularly in France, there is a high level of alcohol consumption per capita (2.51 standard drinks/day/inhabitant in France in 2019). This consumption is not without risk, since 7% of all deaths in France in 2015 were attributable to alcohol, not to mention disabling pathologies and injuries. The treatment of alcohol addiction has many facets (social, neurological, psychological, behavioural, etc.) and involves a number of stages. One aspect that is particularly decisive in the consolidation phase of withdrawal (the phase following withdrawal when the risk of relapse is high) is the motivational dimension, which is widely described in the literature. Motivational Interviewing (MI) is a particularly effective tool for initiating and maintaining change. This tool, provided on a regular basis after discharge from hospital, helps to reinforce and maintain abstinence, a change initiated by users at the time of withdrawal.
- Being tested
- Experimental group : PSH (usual care) with motivational interviewing
- Medical subject headings
- Alcoholism, Behavior, Addictive, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group : PSH (usual care) with motivational interviewingOther
The experimental group will begin follow-up after the 1st inclusion visit, during hospitalisation for withdrawal. The first motivational interview will take place 1 to 4 days before discharge from full hospitalisation. The following 10 motivational interviews will be held 2 weeks apart and will follow a framework based on the following objectives: to create a relationship of trust and an effective and lasting therapeutic alliance from the first interview; to create personalised objectives for the user, in line with their addictive pathology; to support the user as they modify, 'fail' and 'succeed' in achieving these objectives; to encourage the emergence and maintenance of the user's desire to change.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group : PSH (usual care) with motivational interviewing | Experimental | People randomised to the experimental group will have scheduled appointments to collect study data (monthly assessment). They will take part in an initial motivational interview to lay the foundations for the work that will be carried out throughout the follow-up period. Then, for 4 and a half months, a motivational interview will be scheduled every 14 days. Receives: Other: Experimental group : PSH (usual care) with motivational interviewing |
| Control group : PSH (usual care) | No intervention | People randomised to the control group will have scheduled appointments for study-related data collection (monthly assessment), in addition to their routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days of abstinence over the 12 months following hospitalization for alcohol
The measures used for our main criterion will be declarative and collected on paper and by telephone every month in terms of the number of drinks per day. To facilitate data collection, the Timeline Follow Back method [30], developed by Sobell and also validated by telephone, will be used. This tool enables estimates of daily consumption of standard glasses to be collected retrospectively (for up to 12 months). The advantage of this method is that it reduces recall bias, since the participant can fill in a calendar from day to day and the data are collected every month.
Measured: From inclusion,once a month for 1 year
Secondary outcomes (8)
Relapse rates at 5 and 12 months
Percentage of patients who have relapsed (above WHO recommendations for low-risk drinking) at least once in the 5 and 12 months following hospitalisation for alcohol withdrawal. This relapse rate will be calculated on the basis of the consumption schedule collected using the method presented for the primary endpoint.
As a reminder, the recommendations for lower-risk drinking are as follows:
- No more than 10 standard drinks per week
- No more than 2 standard drinks per day
- Have days of the week when no alcohol is consumed.
Measured: From inclusion,once a month for 1 year
Cumulative duration (in days) and maximum duration of abstinence over 5 and 12 months
These cumulative and maximum periods of abstinence will be based on the consumption calendar collected using the Timeline Follow Back method.
Measured: Assessed 5 months after inclusion and 12 months after inclusion
Motivation to maintain abstinence
Assessed using the Stages of Change Readiness and Treatment Eagerness Scale questionnaire
Measured: Assessed 0 month, 5 months and 12 months after inclusion
Craving felt
Assessed using the Obsessive Compulsive Drinking Scale
Measured: Assessed 0 month, 5 months and 12 months after inclusion
Effectiveness of coping strategies
Assessed using the Way og Coping Checklist questionnaire
Measured: Assessed 0 month, 5 months and 12 months after inclusion
Level of anxiety/depression
Assessed using the Hospital Anxiety and Depression scale questionnaire
Measured: Assessed 0 month, 5 months and 12 months after inclusion
Sense of personal effectiveness
Assessed using the Sherer General Self-Efficacy Scale
Measured: Assessed 0 month, 5 months and 12 months after inclusion
Use of other substances
Collection of data declarative data on consumption and quantification in the previous month
Measured: Assessed 0 month, 5 months and 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start18 Dec 2024
- Primary completion13 Jan 2028 (estimated)
- Study completion13 Jan 2028 (estimated)
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, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618755
- Sponsor's protocol ID
- RECHMPL22_0564
- Acronym
- IMMANENCE
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2024
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMANENCE - Intérêt d'un Suivi Sous Forme d'Entretiens Motivationnels spécifiques Post Hospitalisation Sur le Maintien de l'AbstiNENCE Durant l'année Suivant le Sevrage en Alcool
- ClinicalTrials.gov ID
- NCT06618755
- Acronym / sponsor ID
- IMMANENCE / RECHMPL22_0564
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 13 Jan 2028 (estimated)
- Study completion
- 13 Jan 2028 (estimated)
- First posted
- 1 Oct 2024 (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.
The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. The hypothesis is that reinforced post-withdrawal follow-up, of the motivational interview type, during the first 4 months following hospitalisation, in addition to the usual care, would allow :
- Increase the percentage of days of abstinence in the year following withdrawal.
- Reduce the rate of relapse in the year following withdrawal.
- An increase in the cumulative and maximum duration of abstinence, an increase in motivation to maintain the change initiated and a reduction in the use of other substances in the year following withdrawal.
- A reduction in the impact of risk factors involved in the relapse process in the year following withdrawal.
All participants will have assessments to monitor their abstinence and consumption. In addition to their assessments, the experimental group will have motivational talks once every 15 days.
Detailed description
In Europe, and particularly in France, there is a high level of alcohol consumption per capita (2.51 standard drinks/day/inhabitant in France in 2019). This consumption is not without risk, since 7% of all deaths in France in 2015 were attributable to alcohol, not to mention disabling pathologies and injuries. The treatment of alcohol addiction has many facets (social, neurological, psychological, behavioural, etc.) and involves a number of stages. One aspect that is particularly decisive in the consolidation phase of withdrawal (the phase following withdrawal when the risk of relapse is high) is the motivational dimension, which is widely described in the literature. Motivational Interviewing (MI) is a particularly effective tool for initiating and maintaining change. This tool, provided on a regular basis after discharge from hospital, helps to reinforce and maintain abstinence, a change initiated by users at the time of withdrawal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group : PSH (usual care) with motivational interviewing | Experimental | Other: Experimental group : PSH (usual care) with motivational interviewingPeople randomised to the experimental group will have scheduled appointments to collect study data (monthly assessment). They will take part in an initial motivational interview to lay the foundations for the work that will be carried out throughout the follow-up period. Then, for 4 and a half months, a motivational interview will be scheduled every 14 days. |
| Control group : PSH (usual care) | No intervention | –People randomised to the control group will have scheduled appointments for study-related data collection (monthly assessment), in addition to their routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With alcohol use disorders defined by at least 2 DSM-V criteria for at least 12 months).
- Being treated for withdrawal in hospital.
- With a goal of complete abstinence.
- With a means of communication (telephone).
Key exclusion criteria (9 listed)
- Lack of understanding (written and spoken) of the French language.
- Breach of HC withdrawal contract, following failure to comply with the rules of the addictology service and somatic complications of addiction.
- Eviction from the department, discharge against medical advice during hospitalisation for withdrawal.
- Proven cognitive problems compromising understanding of the implications of the study and the proposed follow-up. proposed follow-up.
- Serious decompensated somatic pathology.
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 |
|---|---|---|
| Experimental group : PSH (usual care) with motivational interviewingThe experimental group will begin follow-up after the 1st inclusion visit, during hospitalisation for withdrawal. The first motivational interview will take place 1 to 4 days before discharge from full hospitalisation. The following 10 motivational interviews will be held 2 weeks apart and will follow a framework based on the following objectives: to create a relationship of trust and an effective and lasting therapeutic alliance from the first interview; to create personalised objectives for the user, in line with their addictive pathology; to support the user as they modify, 'fail' and 'succeed' in achieving these objectives; to encourage the emergence and maintenance of the user's desire to change. | Other | Experimental group : PSH (usual care) with motivational interviewing |
Primary outcome
Percentage of days of abstinence over the 12 months following hospitalization for alcohol
Time frame: From inclusion,once a month for 1 year
The measures used for our main criterion will be declarative and collected on paper and by telephone every month in terms of the number of drinks per day. To facilitate data collection, the Timeline Follow Back method [30], developed by Sobell and also validated by telephone, will be used. This tool enables estimates of daily consumption of standard glasses to be collected retrospectively (for up to 12 months). The advantage of this method is that it reduces recall bias, since the participant can fill in a calendar from day to day and the data are collected every month.
8 secondary outcomes
Relapse rates at 5 and 12 months
Time frame: From inclusion,once a month for 1 year
Cumulative duration (in days) and maximum duration of abstinence over 5 and 12 months
Time frame: Assessed 5 months after inclusion and 12 months after inclusion
Motivation to maintain abstinence
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Craving felt
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Effectiveness of coping strategies
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Level of anxiety/depression
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Sense of personal effectiveness
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Use of other substances
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Thomas RISDORFER DE ISSDENTZI contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Alcohol Use Disorder and Addiction, run by University Hospital, Montpellier 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas RISDORFER DE ISSDENTZI (04 67 33 70 20 ext. +33, t-risdorferdeissdentzi@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of days of abstinence over the 12 months following hospitalization for alcohol (time frame: From inclusion,once a month for 1 year). 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 18 Jun 2026.