CravingVITAENCT04927455
Pilot Study to Evaluate "Intégrer et Accompagner Les Consommations d'Alcool!" (IACA!)'s Impact and Transferability
An observational study of Craving and Addiction, Alcohol, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craving, Addiction, Alcohol, Alcoholism
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2021to Apr 2023
- 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: This research will investigate three types of populations: * Individuals receiving support from the IACA! Intervention (called beneficiaries), * Professionals implementing the IACA! Intervention i.e. the pairs in charge of accompanying the beneficiaries in the centers as well as the persons in charge of these centers, * Professionals from Santé! supporting the deployment of the IACA! intervention. The beneficiaries are all persons integrating the program in the project's partner sites and consuming alcohol. The professionals will be specialized educators, social workers, nurses, social and solidarity economy advisors, etc.
Who may be able to join
- Over 18 years of age
- whatever the gender
- Non-opposition to participate
- Inclusion criteria for professionals from centers implementing IACA! :
- Concerning professionals in contact with the patients:
- Having been trained at IACA!
Show all 10Show fewer
- Working in the centers participating in the implementation of IACA!
- Concerning the persons in charge of the centers :
- These professionals are those who have participated in the deployment of the IACA! method in their centers
- Criteria for the inclusion of health professionals ! Participating or having recently participated in the implementation of IACA!
Who cannot join
- The beneficiaries will be excluded if they have a severe somatic or psychiatric pathology that is incompatible with understanding the assessment tools; difficulty understanding and/or writing French; if they are unreachable by telephone, if they are participating in another research project with an ongoing exclusion period, if they are placed under court protection and if they are pregnant.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH Perrens - Equipe Addiction
Bordeaux
MéRISP - Université U1219
Bordeaux
About this study
Official title: Pilot Study to Evaluate Impact and Transferability of an Alcohol Focused Harm Reduction Support System Based on Mental Health Recovery Named IACA!
In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial.
This evaluation requires significant human and material resources. It is therefore recommended to first assess the transferability of IACA! in other care centers in a pilot study.
Read the detailed description
In France, 11% of cancers in men and 4.5% of cancers in women are attributed to alcohol consumption. It is the second leading cause of so-called preventable cancers, accounting for 28,000 alcohol-related cancers out of 352,000 new cases of cancer affecting annually adults (over 30 years of age). Overall, alcohol is among the top 3 factors contributing to Disability-Adjusted life year (DALYs) in France in 2017. Some cancer risks can be quantified as early as one drink a day (oesophagus, oral cavity, pharynx and breast in women). However, the risks associated with alcohol consumption remain influenced by the quantities consumed. There is therefore an interest, particularly for consumers of the largest quantities, in reducing the quantities consumed. In Europe, while people who drink more than 60 g/d of alcohol for men and 40 g/d for women are estimated to represent only 16.1% of the population for men and 9.3% for women, they represent 87% and 82% of alcohol-related morbidity and mortality respectively. Subjects with addiction (or substance use disorders) have an increased risk of social harm (1.5 to 3 times that of alcohol users without addiction), a higher mortality (1.4 to 6.5 compared to the general population) with a life expectancy of 9 to 20 years shorter than that of the general population. Moreover, even if the quantities consumed are not a valid individual diagnostic criterion, studies show a strong association between the quantity consumed and the diagnosis of addiction. Finally, some studies suggest that the prevalence of secondary harm from alcohol use follows an exponential curve as a function of alcohol consumption.
Since 2014, in the PACA region, the association Santé! has been developing an intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! (Integrating and supporting alcohol consumption), differs from the support provided during rehabilitation cures and aims to: fight against discrimination and exclusion of people who drink alcohol, re-engage these individuals in the care process (because they have generally left it) by using the appropriate levers, promote well-being, improve quality of life and recovery and support the recovery in control of consumption. Thus, IACA!, through its philosophy and implementation, is based both on the risk reduction approach historically deployed with drug users and on the recovery approach, developed in the field of mental health. The first one-year results of this program were promising since, of 17 people who received the intervention, all had a social or health benefit, 13 of whom were associated with stabilization (n=4), reduction (n=7) or cessation (n=2) of alcohol use.
These promising results must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial. This type of evaluation requires significant human and material resources. It is therefore recommended to first assess in the field: 1) the conditions under which such an intervention is deployed in other centres (adaptations implemented by other centres to deploy IACA! for example, without distorting the intervention), 2) the acceptability and feasibility of the intervention in other centres (are the human and material resources on site sufficient for the successful deployment of the intervention?), 3) the acceptability and feasibility of the large-scale evaluation envisaged.
- Conditions
- Craving, Addiction, Alcohol, Alcoholism
- Keywords
- Public Health; Alcohol use and addiction; risk reduction; innovation; mental health recovering; Transferability; Viability; Pilot study
- Medical subject headings
- Alcoholism, Alcohol Drinking, Behavior, Addictive, Risk Reduction Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of alcohol use
Measured: 12 months after the start of IACA
Secondary outcomes (45)
Utility dimension of viability - alcohol consumption
Average number of units of alcohol consumption in the past 30 days
Measured: Baseline (M0)
Utility dimension of viability - alcohol consumption
Average number of units of alcohol consumption in the past 30 days
Measured: 3 months (M3)
Utility dimension of viability - alcohol consumption
Average number of units of alcohol consumption in the past 30 days
Measured: 6 months (M6)
Utility dimension of viability - alcohol consumption
Average number of units of alcohol consumption in the past 30 days
Measured: 9 months (M9)
Utility dimension of viability - alcohol consumption
Average number of units of alcohol consumption in the past 30 days
Measured: 12 months (M12)
Utility dimension of viability - craving
Craving: average frequency and intensity in the last 30 days
Measured: Baseline (M0)
Utility dimension of viability - craving
Craving: average frequency and intensity in the last 30 days
Measured: 3 months (M3)
Utility dimension of viability - craving
Craving: average frequency and intensity in the last 30 days
Measured: 6 months (M6)
Utility dimension of viability - craving
Craving: average frequency and intensity in the last 30 days
Measured: 9 months (M9)
Utility dimension of viability - craving
Craving: average frequency and intensity in the last 30 days
Measured: 12 months (M12)
Utility dimension of viability - severity
Severity score for addictive substances and behaviors
Measured: Baseline (M0)
Utility dimension of viability - severity
Severity score for addictive substances and behaviors
Measured: 3 months (M3)
Utility dimension of viability - severity
Severity score for addictive substances and behaviors
Measured: 6 months (M6)
Utility dimension of viability - severity
Severity score for addictive substances and behaviors
Measured: 9 months (M9)
Utility dimension of viability - severity
Severity score for addictive substances and behaviors
Measured: 12 months (M12)
Utility dimension of viability - disorders
Presence of alcohol and other substance use disorders (past 12 months and past)
Measured: Baseline (M0)
Utility dimension of viability - disorders
Presence of alcohol and other substance use disorders (past 12 months and past)
Measured: 3 months (M3)
Utility dimension of viability - disorders
Presence of alcohol and other substance use disorders (past 12 months and past)
Measured: 6 months (M6)
Utility dimension of viability - disorders
Presence of alcohol and other substance use disorders (past 12 months and past)
Measured: 9 months (M9)
Utility dimension of viability - disorders
Presence of alcohol and other substance use disorders (past 12 months and past)
Measured: 12 months (M12)
Utility dimension of viability - Other substances
Number of days of use of other substances/behaviours in the past 30 days
Measured: Baseline (M0)
Utility dimension of viability - Other substances
Number of days of use of other substances/behaviours in the past 30 days
Measured: 3 months (M3)
Utility dimension of viability - Other substances
Number of days of use of other substances/behaviours in the past 30 days
Measured: 6 months (M6)
Utility dimension of viability - Other substances
Number of days of use of other substances/behaviours in the past 30 days
Measured: 9 months (M9)
Utility dimension of viability - Other substances
Number of days of use of other substances/behaviours in the past 30 days
Measured: 12 months (M12)
Utility dimension of viability - Inventory
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
Measured: Baseline (M0)
Utility dimension of viability - Inventory
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
Measured: 3 months (M3)
Utility dimension of viability - Inventory
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
Measured: 6 months (M6)
Utility dimension of viability - Inventory
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
Measured: 9 months (M9)
Utility dimension of viability - Inventory
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
Measured: 12 months (M12)
Utility dimension of viability - QoL
Quality of life
Measured: Baseline (M0)
Utility dimension of viability - QoL
Quality of life
Measured: 3 months (M3)
Utility dimension of viability - QoL
Quality of life
Measured: 6 months (M6)
Utility dimension of viability - QoL
Quality of life
Measured: 9 months (M9)
Utility dimension of viability - QoL
Quality of life
Measured: 12 months (M12)
Conditions of transferability
Conditions of transferability linked to the characteristics of the stakeholders and the context: contextual conditions for success within the centres, the characteristics of professionals and patients influencing outcomes
Measured: 9 to 12 months (M9 to M12)
Viability and implementation
Implementation of IACA! (process, resources, activities) including the respect of IACA! success principles (skills, postures)
Measured: 6 to 12 months (M6 to M12)
Viability and utility
"utility" dimension (as a complement to the secondary criteria) of viability through the recovery mechanisms identified as successful mental health recovery
Measured: 6 to 12 months (M6 to M12)
Viability and affordability
Affordability for professionals and beneficiaries (financial, geographical, social and cultural levers and brakes of the intervention)
Measured: 6 to 12 months (M6 to M12)
Viability and evaluability
Evaluability of IACA: carrying out this evaluation, the availability of professionals and beneficiaries to answer questionnaires and interviews, missing data in the questionnaires etc.
Measured: 6 to 12 months (M6 to M12)
Viability and adaptability
Adaptability of IACA! (integration of the action into the context and the current organisation of the centres)
Measured: 6 to 12 months (M6 to M12)
Viability and acceptability
Acceptability of IACA! by professionals and beneficiaries
Measured: 6 to 12 months (M6 to M12)
Feasibility study capacity
The centres' capacity for inclusion (eligibility, recruitment rate, refusal rate)
Measured: 12 months (M12)
Feasibility study complicance
The compliance rates; understanding, acceptability and feasibility of study questionnaires and data collection tools;
Measured: 12 months (M12)
Feasibility study ressources
The ressources required (time required to complete all study forms, professional/centre capacity, etc.)
Measured: 12 months (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start16 Apr 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CravingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Cambon, PhD, Study chair, Bordeaux University Hospital, Bordeaux University U1219François Alla, MD, PhD, Study director, Bordeaux University Hospital, Bordeaux University U1219Marc Auriacombe, MD, PhD, Study director, CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927455
- Sponsor's protocol ID
- CHUBX 2020/35
- Acronym
- VITAE
- Status last verified
- Feb 2022
- First submitted
- 2 Jun 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Thabane L, Cambon L, Potvin L, Pommier J, Kivits J, Minary L, Nour K, Blaise P, Charlesworth J, Alla F; Discussion Panel. Population health intervention research: what is the place for pilot studies? Trials. 2019 May 30;20(1):309. doi: 10.1186/s13063-019-3422-4.
PubMed 31146768Cambon L, Minary L, Ridde V, Alla F. Transferability of interventions in health education: a review. BMC Public Health. 2012 Jul 2;12:497. doi: 10.1186/1471-2458-12-497.
PubMed 22747988Martin-Fernandez J, Stevens N, Moriceau S, Serre F, Blanc H, Latourte E, Auriacombe M, Cambon L. Realist evaluation of the impact, viability and transferability of an alcohol harm reduction support programme based on mental health recovery: the Vitae study protocol. BMJ Open. 2022 Aug 11;12(8):e065361. doi: 10.1136/bmjopen-2022-065361.
PubMed 35953259
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Impact and Transferability of an Alcohol Focused Harm Reduction Support System Based on Mental Health Recovery Named IACA!
- ClinicalTrials.gov ID
- NCT04927455
- Acronym / sponsor ID
- VITAE / CHUBX 2020/35
- Conditions
- Craving, Addiction, Alcohol, Alcoholism
- Keywords
- Public Health; Alcohol use and addiction; risk reduction; innovation; mental health recovering; Transferability; Viability; Pilot study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 16 Jun 2021 (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.
In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial.
This evaluation requires significant human and material resources. It is therefore recommended to first assess the transferability of IACA! in other care centers in a pilot study.
Detailed description
In France, 11% of cancers in men and 4.5% of cancers in women are attributed to alcohol consumption. It is the second leading cause of so-called preventable cancers, accounting for 28,000 alcohol-related cancers out of 352,000 new cases of cancer affecting annually adults (over 30 years of age). Overall, alcohol is among the top 3 factors contributing to Disability-Adjusted life year (DALYs) in France in 2017. Some cancer risks can be quantified as early as one drink a day (oesophagus, oral cavity, pharynx and breast in women). However, the risks associated with alcohol consumption remain influenced by the quantities consumed. There is therefore an interest, particularly for consumers of the largest quantities, in reducing the quantities consumed. In Europe, while people who drink more than 60 g/d of alcohol for men and 40 g/d for women are estimated to represent only 16.1% of the population for men and 9.3% for women, they represent 87% and 82% of alcohol-related morbidity and mortality respectively. Subjects with addiction (or substance use disorders) have an increased risk of social harm (1.5 to 3 times that of alcohol users without addiction), a higher mortality (1.4 to 6.5 compared to the general population) with a life expectancy of 9 to 20 years shorter than that of the general population. Moreover, even if the quantities consumed are not a valid individual diagnostic criterion, studies show a strong association between the quantity consumed and the diagnosis of addiction. Finally, some studies suggest that the prevalence of secondary harm from alcohol use follows an exponential curve as a function of alcohol consumption.
Since 2014, in the PACA region, the association Santé! has been developing an intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! (Integrating and supporting alcohol consumption), differs from the support provided during rehabilitation cures and aims to: fight against discrimination and exclusion of people who drink alcohol, re-engage these individuals in the care process (because they have generally left it) by using the appropriate levers, promote well-being, improve quality of life and recovery and support the recovery in control of consumption. Thus, IACA!, through its philosophy and implementation, is based both on the risk reduction approach historically deployed with drug users and on the recovery approach, developed in the field of mental health. The first one-year results of this program were promising since, of 17 people who received the intervention, all had a social or health benefit, 13 of whom were associated with stabilization (n=4), reduction (n=7) or cessation (n=2) of alcohol use.
These promising results must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial. This type of evaluation requires significant human and material resources. It is therefore recommended to first assess in the field: 1) the conditions under which such an intervention is deployed in other centres (adaptations implemented by other centres to deploy IACA! for example, without distorting the intervention), 2) the acceptability and feasibility of the intervention in other centres (are the human and material resources on site sufficient for the successful deployment of the intervention?), 3) the acceptability and feasibility of the large-scale evaluation envisaged.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research will investigate three types of populations: * Individuals receiving support from the IACA! Intervention (called beneficiaries), * Professionals implementing the IACA! Intervention i.e. the pairs in charge of accompanying the beneficiaries in the centers as well as the persons in charge of these centers, * Professionals from Santé! supporting the deployment of the IACA! intervention. The beneficiaries are all persons integrating the program in the project's partner sites and consuming alcohol. The professionals will be specialized educators, social workers, nurses, social and solidarity economy advisors, etc.
Key inclusion criteria (10 listed)
- Over 18 years of age
- whatever the gender
- Non-opposition to participate
- Having been trained at IACA!
- Working in the centers participating in the implementation of IACA!
Key exclusion criteria (1 listed)
- The beneficiaries will be excluded if they have a severe somatic or psychiatric pathology that is incompatible with understanding the assessment tools; difficulty understanding and/or writing French; if they are unreachable by telephone, if they are participating in another research project with an ongoing exclusion period, if they are placed under court protection and if they are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of alcohol use
Time frame: 12 months after the start of IACA
45 secondary outcomes
Utility dimension of viability - alcohol consumption
Time frame: Baseline (M0)
Utility dimension of viability - alcohol consumption
Time frame: 3 months (M3)
Utility dimension of viability - alcohol consumption
Time frame: 6 months (M6)
Utility dimension of viability - alcohol consumption
Time frame: 9 months (M9)
Utility dimension of viability - alcohol consumption
Time frame: 12 months (M12)
Utility dimension of viability - craving
Time frame: Baseline (M0)
Utility dimension of viability - craving
Time frame: 3 months (M3)
Utility dimension of viability - craving
Time frame: 6 months (M6)
Utility dimension of viability - craving
Time frame: 9 months (M9)
Utility dimension of viability - craving
Time frame: 12 months (M12)
Utility dimension of viability - severity
Time frame: Baseline (M0)
Utility dimension of viability - severity
Time frame: 3 months (M3)
Utility dimension of viability - severity
Time frame: 6 months (M6)
Utility dimension of viability - severity
Time frame: 9 months (M9)
Utility dimension of viability - severity
Time frame: 12 months (M12)
Utility dimension of viability - disorders
Time frame: Baseline (M0)
Utility dimension of viability - disorders
Time frame: 3 months (M3)
Utility dimension of viability - disorders
Time frame: 6 months (M6)
Utility dimension of viability - disorders
Time frame: 9 months (M9)
Utility dimension of viability - disorders
Time frame: 12 months (M12)
Utility dimension of viability - Other substances
Time frame: Baseline (M0)
Utility dimension of viability - Other substances
Time frame: 3 months (M3)
Utility dimension of viability - Other substances
Time frame: 6 months (M6)
Utility dimension of viability - Other substances
Time frame: 9 months (M9)
Utility dimension of viability - Other substances
Time frame: 12 months (M12)
Utility dimension of viability - Inventory
Time frame: Baseline (M0)
Utility dimension of viability - Inventory
Time frame: 3 months (M3)
Utility dimension of viability - Inventory
Time frame: 6 months (M6)
Utility dimension of viability - Inventory
Time frame: 9 months (M9)
Utility dimension of viability - Inventory
Time frame: 12 months (M12)
Utility dimension of viability - QoL
Time frame: Baseline (M0)
Utility dimension of viability - QoL
Time frame: 3 months (M3)
Utility dimension of viability - QoL
Time frame: 6 months (M6)
Utility dimension of viability - QoL
Time frame: 9 months (M9)
Utility dimension of viability - QoL
Time frame: 12 months (M12)
Conditions of transferability
Time frame: 9 to 12 months (M9 to M12)
Viability and implementation
Time frame: 6 to 12 months (M6 to M12)
Viability and utility
Time frame: 6 to 12 months (M6 to M12)
Viability and affordability
Time frame: 6 to 12 months (M6 to M12)
Viability and evaluability
Time frame: 6 to 12 months (M6 to M12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 31146768Thabane L, Cambon L, Potvin L, Pommier J, Kivits J, Minary L, Nour K, Blaise P, Charlesworth J, Alla F; Discussion Panel. Population health intervention research: what is the place for pilot studies? Trials. 2019 May 30;20(1):309. doi: 10.1186/s13063-019-3422-4.
- Background: PubMed 22747988Cambon L, Minary L, Ridde V, Alla F. Transferability of interventions in health education: a review. BMC Public Health. 2012 Jul 2;12:497. doi: 10.1186/1471-2458-12-497.
- Derived from this study: PubMed 35953259Martin-Fernandez J, Stevens N, Moriceau S, Serre F, Blanc H, Latourte E, Auriacombe M, Cambon L. Realist evaluation of the impact, viability and transferability of an alcohol harm reduction support programme based on mental health recovery: the Vitae study protocol. BMJ Open. 2022 Aug 11;12(8):e065361. doi: 10.1136/bmjopen-2022-065361.
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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.
Linda Cambon, PhD study chair
Bordeaux University Hospital, Bordeaux University U1219
François Alla, MD, PhD study director
Bordeaux University Hospital, Bordeaux University U1219
Marc Auriacombe, MD, PhD study director
CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University
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 Craving and Addiction, Alcohol, run by University Hospital, Bordeaux 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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Feb 2022. 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?
Results are not available in the source record.
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?
Severity of alcohol use (time frame: 12 months after the start of IACA). 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 NCT04927455, which also lists 3 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 16 Feb 2022.