Alcohol Use DisorderETHERNCT03954054
Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder
An observational study of Alcohol Use Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
Trial summary
Alcohol is the most harmful psychoactive substance in terms of overall damage. Although abstinence remains the objective of most pharmacological and non-pharmacological approaches addressing alcohol use disorder (AUD), new therapeutic objectives of reduced alcohol intake and controlled-drinking have emerged. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- "Choizitaconso" - therapeutic patient education programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Oct 2019to 31 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consist in adults with alcohol use disorder eligible to participate to a therapeutic patient education programme.
Who may be able to join
- at least 18 years old
- fluent in French speaker
- able to provide written, informed consent
- reachable by phone
- followed-up for Alcohol Use Disorder
Who cannot join
- cocaine or opiate dependence
- being a legally-protected adult (tutorship, curatorship)
- being pregnant
- participation in another study during the duration of follow-up (6 months)
- having severe cognitive impairment which could conflict with successful group work
Trial locations and contacts
3 sites in 1 country.
France3 sites
CSAPA Convergence
Avignon, 84000
ANPAA 04
Digne-les-Bains
Clinique Saint Barnabé
Marseille, 13015
About this study
Official title: Evaluation of a Therapeutic Education Programme for Harm Reduction in People With Alcohol Use Disorder
Alcohol is the most harmful psychoactive substance in terms of overall damage. Although abstinence remains the objective of most pharmacological and non-pharmacological approaches addressing alcohol use disorder (AUD), new therapeutic objectives of reduced alcohol intake and controlled-drinking have emerged.
ETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or therapeutic education for the reduction of alcohol-related harms) is an ongoing, multicentre, community-based mixed-methods study, which aims to evaluate the innovative therapeutic patient education (TPE) programme named "Choizitaconso". This programme teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms.
The evaluation of the programme will rely on a sequential explanatory design, where the qualitative study (16 semi-structured interviews) will assist in explaining and interpreting the findings of the controlled before-and-after quantitative study.
Read the detailed description
ETHER's quantitative component is a 6-month controlled study which evaluates the effectiveness of "Choizitaconso" by comparing 30 PWAUD following the programme with a control group of 60 PWAUD not following it. All 90 PWAUD are individually interviewed using standardized face-to-face and phone-based interviews.
34 questions on alcohol-related harms were identified in the international literature and approved by the PWAUD community. The sum of these harms, considered as a measure of the individual "burden" related to alcohol use, will be used as principal outcome.
Secondary outcomes are quantity and frequency of alcohol consumption, craving for alcohol, coping strategies, Health-Related Quality of Life (HRQL), self-confidence to resist drinking, anticipated and internalized stigma, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments and capabilities (i.e., a measure of wellbeing for the general adult population, used in economic evaluations).
Primary and secondary outcomes will be collected in face-to-face and phone-based interviews at enrolment and 6 months after enrolment. We will use a binomial test and linear regression models to assess the impact of the TPE programme on changes in the principal and secondary outcomes, while adjusting for other correlates and confounders.
The study's qualitative component comprises semi-structured interviews of 16 PWAUD who completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis.
- Conditions
- Alcohol Use Disorder
- Being tested
- "Choizitaconso" - therapeutic patient education programme
- Keywords
- alcohol, substance use, patient education, psychosocial skills, controlled drinking, harm reduction, abstinence, quality of life
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Choizitaconso" - therapeutic patient education programmeBehavioural
Choizitaconso is a therapeutic patient education programme that teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms.
It lasts for 10 weeks for each participant and consists of the following 5 modules, including one optional module focusing on the family environment:
- Understand the mechanisms that trigger and/or maintain alcohol-related difficulties
- Plan and evaluate personalized controlled drinking strategies
- Understand and identify external and internal influences (e.g., thoughts and emotions), identify and manage risk situations
- Identify alcohol effects and alcohol-related expectations (by developing self-observation skills)
- Family environment: learning how to evaluate and take care of oneself (e.g., how to express feelings)
Each module consists of 2 to 4 collective workshops that each last 120 minutes and involve 5 to 10 persons.
| Study group | Role | What they receive |
|---|---|---|
| Former therapeutic education participants | Semi-structured interviews with people who already completed the TPE programme Receives: Behavioral: "Choizitaconso" - therapeutic patient education programme | |
| Intervention group (current therapeutic education participants) | A face-to-face interview and a telephone interview at treatment initiation (M0) and 6 months after programme initiation (M6)
Administration of socio-economic questionnaires and a Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) before, and 6 months after inclusion in the therapeutic education programme. Receives: Behavioral: "Choizitaconso" - therapeutic patient education programme | |
| Control AUD (Alcohol Use Disorder) patients | A face-to-face interview and a telephone interview at treatment initiation (M0) and 6 months after programme initiation (M6) Administration of socio-economic questionnaires and a Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) before, and 6 months after inclusion in the therapeutic education programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community-validated alcohol-related harms
We selected as principal outcome the number of experienced alcohol-related harms (ranging between 0 and 34) as a measure of the individual alcohol-related "burden".
34 questions on alcohol-related harms (physical, social and behavioural consequences) were identified by and with the community of PWAUD during several working sessions.
Alcohol-related harms assessment is scheduled at enrolment (i.e., before the TPE programme initiation for the intervention group) and 6 months later.
Measured: Compared after 6 months between the intervention- and the control group.
Secondary outcomes (10)
Health-related Quality of life (SF-12v2 health survey)
A validated measure of physical and mental
Measured: Compared after 6 months between the intervention- and the control group.
Average alcohol consumption (AUDIT-C)
Frequency and quantity of alcohol use
Measured: Compared after 6 months between the intervention- and the control group.
Craving
Self-reported control over alcohol consumption, and feelings related to alcohol (5 questions)
Measured: Compared after 6 months between the intervention- and the control group.
Stigma
11 questions on anticipated and internalized stigma drawn from the Substance Use Stigma Mechanism Scale (SU-SMS)
Measured: Compared after 6 months between the intervention- and the control group.
Anxiety and depressive symptoms (HAD)
HAD anxiety and depressive symptoms scale
Measured: Compared after 6 months between the intervention- and the control group.
Alcohol-Related Neuropsychological Impairments (BEARNI)
The Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) test is a clinical screening tool, assessing verbal episodic memory, visuospatial abilities, working memory, executive functioning
Measured: Compared after 6 months in the intervention group
Coping strategies (Brief COPE)
28 questions on cognitive and behavioural efforts to cope with stress in everyday life (trait coping)
Measured: Compared after 6 months between the intervention- and the control group.
Capability (ICECAP-A questionnaire)
A measure of wellbeing for the general adult population, used in economic evaluations.
5 questions on attachment, stability, achievement, enjoyment and autonomy
Measured: Compared after 6 months between the intervention- and the control group.
Treatment self-regulation
Reasons for entering treatment or engaging in healthy behaviour Adaptation of the "Treatment Questionnaire Concerning Diabetes" including 2 subscales: autonomous regulation and controlled regulation
Measured: Compared after 6 months between the intervention- and the control group.
Self-confidence to resist drinking (Brief Situational Confidence Questionnaire)
Confidence to resist (or control) drinking in high-risk situations
Measured: Compared after 6 months between the intervention- and the control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start28 Oct 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Regional Agency for Health PACA, SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954054
- Sponsor's protocol ID
- C19-03 / ETHER
- Acronym
- ETHER
- Status last verified
- Mar 2021
- First submitted
- 9 May 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barre T, Ramier C, Antwerpes S, Costa M, Bureau M, Maradan G, Di Beo V, Cutarella C, Leloutre J, Riccobono-Soulier O, Hedoire S, Frot E, Vernier F, Vassas-Goyard S, Dufort S, Protopopescu C, Marcellin F, Casanova D, Coste M, Carrieri P. A novel community-based therapeutic education program for reducing alcohol-related harms and stigma in people with alcohol use disorders: A quasi-experimental study (ETHER study). Drug Alcohol Rev. 2023 Mar;42(3):664-679. doi: 10.1111/dar.13605. Epub 2023 Jan 31.
PubMed 36721903Antwerpes S, Costa M, Coste M, Bureau M, Maradan G, Cutarella C, Leloutre J, Riccobono-Soulier O, Hedoire S, Frot E, Vernier F, Vassas-Goyard S, Barre T, Casanova D, Carrieri P. Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER). Harm Reduct J. 2022 Jan 10;19(1):2. doi: 10.1186/s12954-021-00587-0.
PubMed 35012570
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Therapeutic Education Programme for Harm Reduction in People With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03954054
- Acronym / sponsor ID
- ETHER / C19-03 / ETHER
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol, substance use, patient education, psychosocial skills, controlled drinking, harm reduction, abstinence, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Regional Agency for Health PACA, SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 17 May 2019 (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.
Alcohol is the most harmful psychoactive substance in terms of overall damage. Although abstinence remains the objective of most pharmacological and non-pharmacological approaches addressing alcohol use disorder (AUD), new therapeutic objectives of reduced alcohol intake and controlled-drinking have emerged.
ETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or therapeutic education for the reduction of alcohol-related harms) is an ongoing, multicentre, community-based mixed-methods study, which aims to evaluate the innovative therapeutic patient education (TPE) programme named "Choizitaconso". This programme teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms.
The evaluation of the programme will rely on a sequential explanatory design, where the qualitative study (16 semi-structured interviews) will assist in explaining and interpreting the findings of the controlled before-and-after quantitative study.
Detailed description
ETHER's quantitative component is a 6-month controlled study which evaluates the effectiveness of "Choizitaconso" by comparing 30 PWAUD following the programme with a control group of 60 PWAUD not following it. All 90 PWAUD are individually interviewed using standardized face-to-face and phone-based interviews.
34 questions on alcohol-related harms were identified in the international literature and approved by the PWAUD community. The sum of these harms, considered as a measure of the individual "burden" related to alcohol use, will be used as principal outcome.
Secondary outcomes are quantity and frequency of alcohol consumption, craving for alcohol, coping strategies, Health-Related Quality of Life (HRQL), self-confidence to resist drinking, anticipated and internalized stigma, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments and capabilities (i.e., a measure of wellbeing for the general adult population, used in economic evaluations).
Primary and secondary outcomes will be collected in face-to-face and phone-based interviews at enrolment and 6 months after enrolment. We will use a binomial test and linear regression models to assess the impact of the TPE programme on changes in the principal and secondary outcomes, while adjusting for other correlates and confounders.
The study's qualitative component comprises semi-structured interviews of 16 PWAUD who completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Former therapeutic education participants | – | Behavioral: "Choizitaconso" - therapeutic patient education programmeSemi-structured interviews with people who already completed the TPE programme |
| Intervention group (current therapeutic education participants) | – | Behavioral: "Choizitaconso" - therapeutic patient education programmeA face-to-face interview and a telephone interview at treatment initiation (M0) and 6 months after programme initiation (M6) Administration of socio-economic questionnaires and a Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) before, and 6 months after inclusion in the therapeutic education programme. |
| Control AUD (Alcohol Use Disorder) patients | – | –A face-to-face interview and a telephone interview at treatment initiation (M0) and 6 months after programme initiation (M6) Administration of socio-economic questionnaires and a Brief Evaluation of Alcohol-Related Neuropsychological Impairment (BEARNI) before, and 6 months after inclusion in the therapeutic education programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consist in adults with alcohol use disorder eligible to participate to a therapeutic patient education programme.
Key inclusion criteria (5 listed)
- at least 18 years old
- fluent in French speaker
- able to provide written, informed consent
- reachable by phone
- followed-up for Alcohol Use Disorder
Key exclusion criteria (5 listed)
- cocaine or opiate dependence
- being a legally-protected adult (tutorship, curatorship)
- being pregnant
- participation in another study during the duration of follow-up (6 months)
- having severe cognitive impairment which could conflict with successful group work
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 |
|---|---|---|
| "Choizitaconso" - therapeutic patient education programmeChoizitaconso is a therapeutic patient education programme that teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms. It lasts for 10 weeks for each participant and consists of the following 5 modules, including one optional module focusing on the family environment: 1. Understand the mechanisms that trigger and/or maintain alcohol-related difficulties 2. Plan and evaluate personalized controlled drinking strategies 3. Understand and identify external and internal influences (e.g., thoughts and emotions), identify and manage risk situations 4. Identify alcohol effects and alcohol-related expectations (by developing self-observation skills) 5. Family environment: learning how to evaluate and take care of oneself (e.g., how to express feelings) Each module consists of 2 to 4 collective workshops that each last 120 minutes and involve 5 to 10 persons. | Behavioural | Former therapeutic education participants, Intervention group (current therapeutic education participants) |
Primary outcome
Community-validated alcohol-related harms
Time frame: Compared after 6 months between the intervention- and the control group.
We selected as principal outcome the number of experienced alcohol-related harms (ranging between 0 and 34) as a measure of the individual alcohol-related "burden". 34 questions on alcohol-related harms (physical, social and behavioural consequences) were identified by and with the community of PWAUD during several working sessions. Alcohol-related harms assessment is scheduled at enrolment (i.e., before the TPE programme initiation for the intervention group) and 6 months later.
10 secondary outcomes
Health-related Quality of life (SF-12v2 health survey)
Time frame: Compared after 6 months between the intervention- and the control group.
Average alcohol consumption (AUDIT-C)
Time frame: Compared after 6 months between the intervention- and the control group.
Craving
Time frame: Compared after 6 months between the intervention- and the control group.
Stigma
Time frame: Compared after 6 months between the intervention- and the control group.
Anxiety and depressive symptoms (HAD)
Time frame: Compared after 6 months between the intervention- and the control group.
Alcohol-Related Neuropsychological Impairments (BEARNI)
Time frame: Compared after 6 months in the intervention group
Coping strategies (Brief COPE)
Time frame: Compared after 6 months between the intervention- and the control group.
Capability (ICECAP-A questionnaire)
Time frame: Compared after 6 months between the intervention- and the control group.
Treatment self-regulation
Time frame: Compared after 6 months between the intervention- and the control group.
Self-confidence to resist drinking (Brief Situational Confidence Questionnaire)
Time frame: Compared after 6 months between the intervention- and the control group.
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 18 Nov 2025.
- Results publication: PubMed 36721903Barre T, Ramier C, Antwerpes S, Costa M, Bureau M, Maradan G, Di Beo V, Cutarella C, Leloutre J, Riccobono-Soulier O, Hedoire S, Frot E, Vernier F, Vassas-Goyard S, Dufort S, Protopopescu C, Marcellin F, Casanova D, Coste M, Carrieri P. A novel community-based therapeutic education program for reducing alcohol-related harms and stigma in people with alcohol use disorders: A quasi-experimental study (ETHER study). Drug Alcohol Rev. 2023 Mar;42(3):664-679. doi: 10.1111/dar.13605. Epub 2023 Jan 31.
- Results publication: PubMed 35012570Antwerpes S, Costa M, Coste M, Bureau M, Maradan G, Cutarella C, Leloutre J, Riccobono-Soulier O, Hedoire S, Frot E, Vernier F, Vassas-Goyard S, Barre T, Casanova D, Carrieri P. Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER). Harm Reduct J. 2022 Jan 10;19(1):2. doi: 10.1186/s12954-021-00587-0.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Institut National de la Santé Et de la Recherche Médicale, France at 3 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 5 inclusion and 5 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Community-validated alcohol-related harms (time frame: Compared after 6 months between the intervention- and the control group.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03954054, which also lists 2 linked publications.
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 Nov 2025.