Addiction DisordersPAPRICANCT06580756
Problematic Use and Addiction in Primary Care
An observational study of Addiction Disorders and Primary Care, run by University Hospital, Tours at 3 sites in France.
Trial summary
The morbi-mortality and social cost of addictive disorders led the French authorities to set up a government plan in 2018 to combat drugs and addictive behavior (Interministerial mission to combat drugs and addictive behaviour - (MILDECA)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction Disorders, Primary Care
- What is being tested?
- Short training program
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2025to Aug 2028
- Phase
- Observational
- 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
Study population: Primary care ambulatory professional
Who may be able to join
- be a primary care professional (physiotherapists, nurses, midwives, dentists, pharmacists, General practitioner)
- in ambulatory practice. Recruitment will be carried out with the help of territorial professional health communities, to include practitioners practicing in conditions representative of the diversity of primary care practice.
- GPs agreeing to take part will be divided into a control group and an intervention group, by drawing lots.
Who cannot join
- Refusal to participate.
- The same participant may not be included in more than one stage.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
CPTS Lanmeur
Lanmeur, 29620
Jean Yves LE RESTE, lereste@univ-brest.fr
CPTS Sud Lochois
Ligueil, 37240
Maxime PAUTRAT, maxime.pautrat@univ-tours.fr
CPTS du Vendomois
Vendôme, 41100
Alain AUMARECHAL, alain.aumarechal@univ-tours.fr
About this study
Official title: Development and Validation of a Short Training Course to Help Primary Care Healthcare Professionals Identify Addictive Disorders
The morbi-mortality and social cost of addictive disorders led the French authorities to set up a government plan in 2018 to combat drugs and addictive behavior (Interministerial mission to combat drugs and addictive behaviour - (MILDECA)). In particular, it encourages early detection, which is the first stage in a validated global approach to the management of addictive disorders. Improving early identification of addictive disorders in primary care would reduce morbidity and mortality and improve quality of life for patients with addictive disorders. The identification of use disorders should be systematic in primary care and was the subject of a recommendation in 2015. Numerous tests are cited in these recommendations, but few have actually been validated in primary care, and none has been shown to be feasible. For example, only 23% of GPs claim to systematically identify alcohol consumption.
Other primary care professionals (physiotherapists, nurses, midwives, dentists, pharmacists) also have a role to play in identifying addictive disorders. The evolution of their respective professions (delegation of tasks, creation of the profession of advanced practice nurse, medical assistants) and the recent reorganization of the practice framework, both in terms of practice structures and professional community organizations, involve them in a global multidisciplinary collaboration on patient care, particularly in the early identification of addictive disorders.
Read more
The hypothesis is that the difficulties in implementing tests to identify addictive disorders in primary care are linked to the lack of specific consideration of the needs of primary care patients and caregivers.
The overall aim of the study is to improve the early detection of addictive disorders through brief training for primary care healthcare professionals.
Read the detailed description
The project comprises three successive stages:
- Design a training program with content tailored to primary care professionals;
- Evaluate the feasibility and acceptability of the training;
- Evaluate the implementation of this training program by comparing the incidence of addiction disorder detection by primary care professionals between a trained and an untrained group.
- Conditions
- Addiction Disorders, Primary Care
- Being tested
- Short training program
- Keywords
- short training program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short training programOther
Training in the early identification of addictive disorders in primary care
| Study group | Role | What they receive |
|---|---|---|
| group intervention | Group with a brief training Receives: Other: Short training program | |
| group control | Group without a brief training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who received information about the addictive disorders from the primary care professional
The main aim of the study was to measure the effect of brief training in the identification of addictive disorders on the rate of patients who actually received the information from the primary care professional.
Measured: 24 months
number of patients identified with an addictive disorder from the primary care professional
The main aim of the study was to measure the effect of brief training in the identification of addictive disorders on the rate of patients who actually received the information from the primary care professional.
Measured: 24 months
Secondary outcomes (2)
prevalence of addictive disorders in primary care
Measure the prevalence
Measured: 24 months
types of addictive disorders
List of addictive disorders identified in patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startSep 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction DisordersStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime PAUTRAT, Principal investigator, Tours university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580756
- Sponsor's protocol ID
- DR230127-PAPRICA
- Acronym
- PAPRICA
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2024
- Last updated
- 9 Dec 2024
- 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Short Training Course to Help Primary Care Healthcare Professionals Identify Addictive Disorders
- ClinicalTrials.gov ID
- NCT06580756
- Acronym / sponsor ID
- PAPRICA / DR230127-PAPRICA
- Conditions
- Addiction Disorders, Primary Care
- Keywords
- short training program
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Aug 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 morbi-mortality and social cost of addictive disorders led the French authorities to set up a government plan in 2018 to combat drugs and addictive behavior (Interministerial mission to combat drugs and addictive behaviour - (MILDECA)). In particular, it encourages early detection, which is the first stage in a validated global approach to the management of addictive disorders. Improving early identification of addictive disorders in primary care would reduce morbidity and mortality and improve quality of life for patients with addictive disorders. The identification of use disorders should be systematic in primary care and was the subject of a recommendation in 2015. Numerous tests are cited in these recommendations, but few have actually been validated in primary care, and none has been shown to be feasible. For example, only 23% of GPs claim to systematically identify alcohol consumption.
Other primary care professionals (physiotherapists, nurses, midwives, dentists, pharmacists) also have a role to play in identifying addictive disorders. The evolution of their respective professions (delegation of tasks, creation of the profession of advanced practice nurse, medical assistants) and the recent reorganization of the practice framework, both in terms of practice structures and professional community organizations, involve them in a global multidisciplinary collaboration on patient care, particularly in the early identification of addictive disorders.
The hypothesis is that the difficulties in implementing tests to identify addictive disorders in primary care are linked to the lack of specific consideration of the needs of primary care patients and caregivers.
The overall aim of the study is to improve the early detection of addictive disorders through brief training for primary care healthcare professionals.
Detailed description
The project comprises three successive stages:
- Design a training program with content tailored to primary care professionals;
- Evaluate the feasibility and acceptability of the training;
- Evaluate the implementation of this training program by comparing the incidence of addiction disorder detection by primary care professionals between a trained and an untrained group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group intervention | – | Other: Short training programGroup with a brief training |
| group control | – | –Group without a brief training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care ambulatory professional
Key inclusion criteria (3 listed)
- be a primary care professional (physiotherapists, nurses, midwives, dentists, pharmacists, General practitioner)
- in ambulatory practice. Recruitment will be carried out with the help of territorial professional health communities, to include practitioners practicing in conditions representative of the diversity of primary care practice.
- GPs agreeing to take part will be divided into a control group and an intervention group, by drawing lots.
Key exclusion criteria (2 listed)
- Refusal to participate.
- The same participant may not be included in more than one stage.
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 |
|---|---|---|
| Short training programTraining in the early identification of addictive disorders in primary care | Other | group intervention |
Primary outcome
Number of patients who received information about the addictive disorders from the primary care professional
Time frame: 24 months
The main aim of the study was to measure the effect of brief training in the identification of addictive disorders on the rate of patients who actually received the information from the primary care professional.
number of patients identified with an addictive disorder from the primary care professional
Time frame: 24 months
The main aim of the study was to measure the effect of brief training in the identification of addictive disorders on the rate of patients who actually received the information from the primary care professional.
2 secondary outcomes
prevalence of addictive disorders in primary care
Time frame: 24 months
types of addictive disorders
Time frame: 24 months
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 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Addiction Disorders
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
Recruiting
Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music
Substance Use Disorder (SUD)
Not yet recruiting
Evaluation of Interventions to Promote Work-Life Balance Among Students at Gaming Schools
Internet Gaming Disorder
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.
Maxime PAUTRAT principal investigator
Tours university
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 Addiction Disorders and Primary Care, run by University Hospital, Tours 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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Dec 2024. 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?
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 Maxime PAUTRAT (02 47 59 61 52 ext. +33, maxime.pautrat@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who received information about the addictive disorders from the primary care professional (time frame: 24 months). The study lists 2 primary outcomes in all. 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 9 Dec 2024.