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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in France

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.

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.

  1. Severity of alcohol use

    Measured: 12 months after the start of IACA

Secondary outcomes (45)
  1. Utility dimension of viability - alcohol consumption

    Average number of units of alcohol consumption in the past 30 days

    Measured: Baseline (M0)

  2. Utility dimension of viability - alcohol consumption

    Average number of units of alcohol consumption in the past 30 days

    Measured: 3 months (M3)

  3. Utility dimension of viability - alcohol consumption

    Average number of units of alcohol consumption in the past 30 days

    Measured: 6 months (M6)

  4. Utility dimension of viability - alcohol consumption

    Average number of units of alcohol consumption in the past 30 days

    Measured: 9 months (M9)

  5. Utility dimension of viability - alcohol consumption

    Average number of units of alcohol consumption in the past 30 days

    Measured: 12 months (M12)

  6. Utility dimension of viability - craving

    Craving: average frequency and intensity in the last 30 days

    Measured: Baseline (M0)

  7. Utility dimension of viability - craving

    Craving: average frequency and intensity in the last 30 days

    Measured: 3 months (M3)

  8. Utility dimension of viability - craving

    Craving: average frequency and intensity in the last 30 days

    Measured: 6 months (M6)

  9. Utility dimension of viability - craving

    Craving: average frequency and intensity in the last 30 days

    Measured: 9 months (M9)

  10. Utility dimension of viability - craving

    Craving: average frequency and intensity in the last 30 days

    Measured: 12 months (M12)

  11. Utility dimension of viability - severity

    Severity score for addictive substances and behaviors

    Measured: Baseline (M0)

  12. Utility dimension of viability - severity

    Severity score for addictive substances and behaviors

    Measured: 3 months (M3)

  13. Utility dimension of viability - severity

    Severity score for addictive substances and behaviors

    Measured: 6 months (M6)

  14. Utility dimension of viability - severity

    Severity score for addictive substances and behaviors

    Measured: 9 months (M9)

  15. Utility dimension of viability - severity

    Severity score for addictive substances and behaviors

    Measured: 12 months (M12)

  16. Utility dimension of viability - disorders

    Presence of alcohol and other substance use disorders (past 12 months and past)

    Measured: Baseline (M0)

  17. Utility dimension of viability - disorders

    Presence of alcohol and other substance use disorders (past 12 months and past)

    Measured: 3 months (M3)

  18. Utility dimension of viability - disorders

    Presence of alcohol and other substance use disorders (past 12 months and past)

    Measured: 6 months (M6)

  19. Utility dimension of viability - disorders

    Presence of alcohol and other substance use disorders (past 12 months and past)

    Measured: 9 months (M9)

  20. Utility dimension of viability - disorders

    Presence of alcohol and other substance use disorders (past 12 months and past)

    Measured: 12 months (M12)

  21. Utility dimension of viability - Other substances

    Number of days of use of other substances/behaviours in the past 30 days

    Measured: Baseline (M0)

  22. Utility dimension of viability - Other substances

    Number of days of use of other substances/behaviours in the past 30 days

    Measured: 3 months (M3)

  23. Utility dimension of viability - Other substances

    Number of days of use of other substances/behaviours in the past 30 days

    Measured: 6 months (M6)

  24. Utility dimension of viability - Other substances

    Number of days of use of other substances/behaviours in the past 30 days

    Measured: 9 months (M9)

  25. Utility dimension of viability - Other substances

    Number of days of use of other substances/behaviours in the past 30 days

    Measured: 12 months (M12)

  26. Utility dimension of viability - Inventory

    Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days

    Measured: Baseline (M0)

  27. Utility dimension of viability - Inventory

    Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days

    Measured: 3 months (M3)

  28. Utility dimension of viability - Inventory

    Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days

    Measured: 6 months (M6)

  29. Utility dimension of viability - Inventory

    Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days

    Measured: 9 months (M9)

  30. Utility dimension of viability - Inventory

    Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days

    Measured: 12 months (M12)

  31. Utility dimension of viability - QoL

    Quality of life

    Measured: Baseline (M0)

  32. Utility dimension of viability - QoL

    Quality of life

    Measured: 3 months (M3)

  33. Utility dimension of viability - QoL

    Quality of life

    Measured: 6 months (M6)

  34. Utility dimension of viability - QoL

    Quality of life

    Measured: 9 months (M9)

  35. Utility dimension of viability - QoL

    Quality of life

    Measured: 12 months (M12)

  36. 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)

  37. 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)

  38. 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)

  39. 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)

  40. 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)

  41. 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)

  42. Viability and acceptability

    Acceptability of IACA! by professionals and beneficiaries

    Measured: 6 to 12 months (M6 to M12)

  43. Feasibility study capacity

    The centres' capacity for inclusion (eligibility, recruitment rate, refusal rate)

    Measured: 12 months (M12)

  44. Feasibility study complicance

    The compliance rates; understanding, acceptability and feasibility of study questionnaires and data collection tools;

    Measured: 12 months (M12)

  45. 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.

  1. First posted16 Jun 2021
  2. Study start16 Apr 2021
  3. Primary completionApr 2022 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

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)
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 31146768
  • Cambon 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 22747988
  • Martin-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

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.

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