Alcohol AbusePhase 3ITBCHIRNCT01348113
Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery
A Phase 3 study testing Brief Alcohol intervention in people with Alcohol Abuse and Alcohol Problem, run by Rennes University Hospital at 1 site in France.
Trial summary
Excessive alcohol consumption is a worldwide major public health problem. Brief interventions have shown to be an efficient treatment modality for problem drinkers, but have never been tested in scheduled surgery. Patients will be recruited in various surgery units in 7 hospital in France. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Problem, AOD Misuse
- What is being tested?
- Brief Alcohol intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Nov 2012
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman
- Aged 30 to 75 years old
- With a scheduled surgery
- Presenting an Alcohol Use Disorders Identification Test score between 7 and 12 (included) during the routine visit with the anaesthesist prior to hospitalisation
- Being capable of understanding the information note
- Who gave a written informed consent
Show all 18Show fewer
- Affiliated to a medical insurance
- Non inclusion Criteria:
- Surgery in relation to alcohol consumption (chronic pancreatitis, oropharyngeal cancer for example) or modifying alcohol consumption (liver transplantation for example),
- No telephone number
- Dependence to alcohol (Alcohol Use Disorders Identification Test score ≥ 13)
- History of alcohol weaning complications
- History of addiction care
- Life expectancy less than 5 years
- Decompensated psychiatric disease
- Usual consumption (more than three times a week) of illicit products
- Person deprived of freedom or under guardianship
- Participation or intent to participate in another biomedical research
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou
Rennes, 35033
About this study
Official title: Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial
Excessive alcohol consumption is a worldwide major public health problem. Brief interventions have shown to be an efficient treatment modality for problem drinkers, but have never been tested in scheduled surgery.
Patients will be recruited in various surgery units in 7 hospital in France. All patients attending a scheduled surgery will be screened during the visit with the anaesthesist by the Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between 7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study and randomized between a brief intervention by a trained nurse during the post-surgery hospitalisation and no intervention. Twelve months after the surgery, a research technician will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last month.
Read the detailed description
Excessive alcohol consumption is a worldwide major public health problem. Persons who drink more than 2-3 drinks per day are at risk for numerous medical, psychological and social problems. Brief interventions have shown to be an efficient treatment modality for problem drinkers in settings such as primary care, emergencies or psychiatric hospitals by numerous randomized studies. Brief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included. Brief interventions seem to be particularly effective in patients with alcohol problem without dependence.
Screening for alcohol problem is best done using standardized questionnaires, as the Alcohol Use Disorders Identification Test (AUDIT), developed by WHO and translated in many languages. The AUDIT allows distinguishing between normal alcohol use, harmful or at risk use and dependence and is easy to use.
No study on brief intervention has been conducted in scheduled surgery. This seems to be a promising situation, since there is first a visit with the anaesthetist, during which screening for alcohol problem should occur, then a hospitalisation, during which the intervention could be made. It is possible that patients are more concerned by their health when they come to hospital for a surgery.
The aim of this controlled, randomized study is to test the hypothesis that a brief intervention, consisting in a visit with a trained nurse, followed by a telephone call three months later, in patients with at risk or harmful alcohol use, undergoing a scheduled surgery, could be efficient to promote the decrease of alcohol consumption.
Patients will be screened during the visit with the anaesthetist with AUDIT. Patients with AUDIT between 7 and 12 will be proposed to enter the study, and randomised between Brief Intervention and no intervention. A research technician will interview patients 12 months after the surgery, with assessment of the AUDIT and alcohol consumption. CDT and GGT will be measured prior to surgery, then at 12 months after surgery.
- Conditions
- Alcohol Abuse, Alcohol Problem, AOD Misuse
- Being tested
- Brief Alcohol intervention
- Keywords
- Alcohol Use Disorders Identification Test, alcohol dependence, Alcohol problem
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Alcohol interventionOther
Also called BAI
Brief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included.
| Study group | Role | What they receive |
|---|---|---|
| Brief Alcohol Intervention | Experimental | Not described Receives: Other: Brief Alcohol intervention |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7
Measured: 1 year
Secondary outcomes (8)
Evolution of the Alcohol Use Disorders Identification Test score
Measured: 1 year
Alcohol consumption in the month preceding the final evaluation at 1 year
Measured: 1 year
Gamma-GT and CDT evolution
Measured: 1 year
Frequency of normalization of gamma-GT and CDT measures
Measured: 1 year
Rate of patients in the Brief Alcohol Intervention group getting back to an Alcohol Use Disorders Identification Test score <7, with stratification on the Prochaska score
Measured: 1 year
Feeling of the patients towards the Brief Alcohol Intervention
recollection, acceptability, relevance, recollection of the recall at 3 months, acceptability of the recall at 3 months
Measured: 1 year
Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation
Measured: 6 months
Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Romain MOIRAND, MD, PhD, Principal investigator, Rennes University HospitalJean-Michel REYMANN, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348113
- Sponsor's protocol ID
- RCB 2009-A00591-56
- Other IDs
- PHRC/09-09
- Acronym
- ITBCHIR
- Status last verified
- Apr 2014
- First submitted
- 2 Jul 2010
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01348113
- Acronym / sponsor ID
- ITBCHIR / RCB 2009-A00591-56
- Conditions
- Alcohol Abuse, Alcohol Problem, AOD Misuse
- Keywords
- Alcohol Use Disorders Identification Test, alcohol dependence, Alcohol problem
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- 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.
Excessive alcohol consumption is a worldwide major public health problem. Brief interventions have shown to be an efficient treatment modality for problem drinkers, but have never been tested in scheduled surgery.
Patients will be recruited in various surgery units in 7 hospital in France. All patients attending a scheduled surgery will be screened during the visit with the anaesthesist by the Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between 7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study and randomized between a brief intervention by a trained nurse during the post-surgery hospitalisation and no intervention. Twelve months after the surgery, a research technician will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last month.
Detailed description
Excessive alcohol consumption is a worldwide major public health problem. Persons who drink more than 2-3 drinks per day are at risk for numerous medical, psychological and social problems. Brief interventions have shown to be an efficient treatment modality for problem drinkers in settings such as primary care, emergencies or psychiatric hospitals by numerous randomized studies. Brief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included. Brief interventions seem to be particularly effective in patients with alcohol problem without dependence.
Screening for alcohol problem is best done using standardized questionnaires, as the Alcohol Use Disorders Identification Test (AUDIT), developed by WHO and translated in many languages. The AUDIT allows distinguishing between normal alcohol use, harmful or at risk use and dependence and is easy to use.
No study on brief intervention has been conducted in scheduled surgery. This seems to be a promising situation, since there is first a visit with the anaesthetist, during which screening for alcohol problem should occur, then a hospitalisation, during which the intervention could be made. It is possible that patients are more concerned by their health when they come to hospital for a surgery.
The aim of this controlled, randomized study is to test the hypothesis that a brief intervention, consisting in a visit with a trained nurse, followed by a telephone call three months later, in patients with at risk or harmful alcohol use, undergoing a scheduled surgery, could be efficient to promote the decrease of alcohol consumption.
Patients will be screened during the visit with the anaesthetist with AUDIT. Patients with AUDIT between 7 and 12 will be proposed to enter the study, and randomised between Brief Intervention and no intervention. A research technician will interview patients 12 months after the surgery, with assessment of the AUDIT and alcohol consumption. CDT and GGT will be measured prior to surgery, then at 12 months after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Alcohol Intervention | Experimental | Other: Brief Alcohol intervention |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Man or woman
- Aged 30 to 75 years old
- With a scheduled surgery
- Presenting an Alcohol Use Disorders Identification Test score between 7 and 12 (included) during the routine visit with the anaesthesist prior to hospitalisation
- Being capable of understanding the information note
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Brief Alcohol interventionAlso: BAIBrief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included. | Other | Brief Alcohol Intervention |
Primary outcome
Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7
Time frame: 1 year
8 secondary outcomes
Evolution of the Alcohol Use Disorders Identification Test score
Time frame: 1 year
Alcohol consumption in the month preceding the final evaluation at 1 year
Time frame: 1 year
Gamma-GT and CDT evolution
Time frame: 1 year
Frequency of normalization of gamma-GT and CDT measures
Time frame: 1 year
Rate of patients in the Brief Alcohol Intervention group getting back to an Alcohol Use Disorders Identification Test score <7, with stratification on the Prochaska score
Time frame: 1 year
Feeling of the patients towards the Brief Alcohol Intervention
Time frame: 1 year
Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation
Time frame: 6 months
Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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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.
Romain MOIRAND, MD, PhD principal investigator
Rennes University Hospital
Jean-Michel REYMANN, PhD study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief Alcohol intervention in people with Alcohol Abuse and Alcohol Problem, run by Rennes University Hospital 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 18 inclusion and 0 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: stopped early, as of the sponsor's last update on 1 May 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7 (time frame: 1 year). 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 1 May 2014.