AlcoholismNCT04647565
Alcohol and Women : Screening in General
An observational study of Alcoholism, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alcoholism
- What is being tested?
- interviews
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 30 Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Over 18 years old alcoholic womens, medical caring in consultation with addictologist or in hospitalisation for withdrawal.
Who may be able to join
- over 18 years old alcoholic women, with one or several addiction, from all social class.
Who cannot join
- not being able to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alcohol and Women : Screening in General Medicine.
The alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. Finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (AUD) in general medicine.
Read the detailed description
To improve the screening of women with AUD in general médicine, from their perceptions and experiences, and to create a screening tool to general practitioners.
The chosen method is a qualtitative study through semi-structured interview with women with AUD.
A qualitative assessment of these individual interviews could show various topics.
- Conditions
- Alcoholism
- Being tested
- interviews
- Keywords
- women reporting alcohol abuse and/or dependence, women recruted during hospitalisation and/or consultation, Alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewsOther
interviews (human and social sciences)
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of women's opinion on an alcoholism screening by general practitioners.
Assessment of women's opinion on an alcoholism screening by general practitioners : Qualitative study based on semi-structured interview with women with AUD.
Measured: 1 year
Creation of a screening tool dedicated to general practitioners
Creation of a screening tool dedicated to general practitioners : Built of a screening tool based both on litterature review about alcohol \& women and a qualitative study on women's opinion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire MONTADE, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647565
- Sponsor's protocol ID
- RECHMPL20_0611
- Status last verified
- Oct 2021
- First submitted
- 23 Nov 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Women : Screening in General Medicine.
- ClinicalTrials.gov ID
- NCT04647565
- Acronym / sponsor ID
- RECHMPL20_0611
- Conditions
- Alcoholism
- Keywords
- women reporting alcohol abuse and/or dependence, women recruted during hospitalisation and/or consultation, Alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 1 Dec 2020 (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 alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. Finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (AUD) in general medicine.
Detailed description
To improve the screening of women with AUD in general médicine, from their perceptions and experiences, and to create a screening tool to general practitioners.
The chosen method is a qualtitative study through semi-structured interview with women with AUD.
A qualitative assessment of these individual interviews could show various topics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 years old alcoholic womens, medical caring in consultation with addictologist or in hospitalisation for withdrawal.
Key inclusion criteria (1 listed)
- over 18 years old alcoholic women, with one or several addiction, from all social class.
Key exclusion criteria (1 listed)
- not being able to answer the questionnaire
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 |
|---|---|---|
| interviewsinterviews (human and social sciences) | Other | – |
Primary outcome
Assessment of women's opinion on an alcoholism screening by general practitioners.
Time frame: 1 year
Assessment of women's opinion on an alcoholism screening by general practitioners : Qualitative study based on semi-structured interview with women with AUD.
Creation of a screening tool dedicated to general practitioners
Time frame: 1 year
Creation of a screening tool dedicated to general practitioners : Built of a screening tool based both on litterature review about alcohol \& women and a qualitative study on women's opinion.
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 25 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Claire MONTADE principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism, 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 1 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: finished, as of the sponsor's last update on 25 Oct 2021. 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?
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?
Assessment of women's opinion on an alcoholism screening by general practitioners. (time frame: 1 year). 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 25 Oct 2021.