Alcohol AddictionNCT02374905
Testing Interventions to Reduce Alcohol Consumption Among Outpatients in a Dental Setting
A study testing Drinksmeter and Brief Advice of Alcohol Use in people with Alcohol Addiction and Mouth Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The investigators wish to investigate the feasibility of using a web based drinking app (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient clinic in a dental setting. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Addiction, Mouth Diseases
- What is being tested?
- Drinksmeter and Brief Advice of Alcohol Use
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Aug 2018
- Phase
- Interventional
- 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 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient attending the Department of Oral Medicine at King's College Hospital and consuming alcohol over recommended guidance (European Code Against Cancer)
Who cannot join
- Patient which cannot understand English
- Complete lack of IT literacy
- Patient in contact with a specialized alcohol service
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic
The investigators wish to investigate the feasibility of using a web based drinking app (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient clinic in a dental setting.
Read the detailed description
Any intervention on alcohol use is relevant to patients attending an oral medicine clinic, as alcohol can contribute to/or worsen mouth disorders. For example, research confirms that white and red patches of the lining of the mouth in regular tobacco and alcohol users can change to mouth cancer. Many people do not know that drinking alcohol would increase their mouth cancer risk.
Any new or follow-up patients attending our clinic and reporting drinking over the recommended guidelines (as given by European Code Against Cancer) will be eligible to participate. The study will start on the first visit to the clinic and/or at their follow-up visit. For each volunteer the study will last 3 months. Participants will be allocated to two groups, those receiving routine brief counselling on the day of their visit and those to whom a web-based electronic tool to self-assess is introduced. They will be motivated to use it in the following weeks to reduce consumption . The study will evaluate alcohol consumption levels using tested questionnaires at base-line and exit.
The investigators will assess the feasibility of the use of an electronic tool in our study population, whether it provided better outcomes compared to standard care.
- Conditions
- Alcohol Addiction, Mouth Diseases
- Being tested
- Drinksmeter, Brief Advice of Alcohol Use
- Keywords
- drinksmeter, alcohol counselling
- Medical subject headings
- Alcoholism, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrinksmeterDevice
Web-based application delivering Identification and Brief Advice of Alcohol Use
Brief Advice of Alcohol UseBehavioural
Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician
| Study group | Role | What they receive |
|---|---|---|
| Drinksmeter | Experimental | Web-based application delivering Identification and Brief Advice of Alcohol Use Receives: Device: Drinksmeter; Behavioral: Brief Advice of Alcohol Use |
| Brief Advice of Alcohol Use | Active comparator | Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician Receives: Behavioral: Brief Advice of Alcohol Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mean number of alcohol units consumed per week
Number of weekly alcohol units will be recorded before intervention and 3-6 months after intervention
Measured: 6-12 months
Secondary outcomes (1)
Improvement of AUDIT-10 (Alcohol Use Disorders Identification Test) Questionnaire Score
AUDIT-10 questionnaire given before and after intervention. A total score is given for the questionnaire based on the answers given. This total score will be compared before and after.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: Staff changes and retirement of the primary investigator during the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AddictionStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Principal investigator, Saman Warnakulasuriya, King's College Hospital NHS Trust
- Investigators
- Saman Warnakulasuriya, BDS,PhD,DSc, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374905
- Sponsor's protocol ID
- KCH 14-158
- Status last verified
- Sep 2019
- First submitted
- 16 Feb 2015
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic
- ClinicalTrials.gov ID
- NCT02374905
- Acronym / sponsor ID
- KCH 14-158
- Conditions
- Alcohol Addiction, Mouth Diseases
- Keywords
- drinksmeter, alcohol counselling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staff changes and retirement of the primary investigator during the study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- Oct 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 Mar 2015 (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.
The investigators wish to investigate the feasibility of using a web based drinking app (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient clinic in a dental setting.
Detailed description
Any intervention on alcohol use is relevant to patients attending an oral medicine clinic, as alcohol can contribute to/or worsen mouth disorders. For example, research confirms that white and red patches of the lining of the mouth in regular tobacco and alcohol users can change to mouth cancer. Many people do not know that drinking alcohol would increase their mouth cancer risk.
Any new or follow-up patients attending our clinic and reporting drinking over the recommended guidelines (as given by European Code Against Cancer) will be eligible to participate. The study will start on the first visit to the clinic and/or at their follow-up visit. For each volunteer the study will last 3 months. Participants will be allocated to two groups, those receiving routine brief counselling on the day of their visit and those to whom a web-based electronic tool to self-assess is introduced. They will be motivated to use it in the following weeks to reduce consumption . The study will evaluate alcohol consumption levels using tested questionnaires at base-line and exit.
The investigators will assess the feasibility of the use of an electronic tool in our study population, whether it provided better outcomes compared to standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drinksmeter | Experimental | Device: Drinksmeter, Behavioral: Brief Advice of Alcohol UseWeb-based application delivering Identification and Brief Advice of Alcohol Use |
| Brief Advice of Alcohol Use | Active comparator | Behavioral: Brief Advice of Alcohol UseLifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient attending the Department of Oral Medicine at King's College Hospital and consuming alcohol over recommended guidance (European Code Against Cancer)
Key exclusion criteria (3 listed)
- Patient which cannot understand English
- Complete lack of IT literacy
- Patient in contact with a specialized alcohol service
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 |
|---|---|---|
| DrinksmeterWeb-based application delivering Identification and Brief Advice of Alcohol Use | Device | Drinksmeter |
| Brief Advice of Alcohol UseLifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician | Behavioural | Brief Advice of Alcohol Use, Drinksmeter |
Primary outcome
Reduction in mean number of alcohol units consumed per week
Time frame: 6-12 months
Number of weekly alcohol units will be recorded before intervention and 3-6 months after intervention
1 secondary outcome
Improvement of AUDIT-10 (Alcohol Use Disorders Identification Test) Questionnaire Score
Time frame: 6-12 months
Results and safety
The study was stopped early (reason given: Staff changes and retirement of the primary investigator during the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Saman Warnakulasuriya, BDS,PhD,DSc study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drinksmeter and Brief Advice of Alcohol Use in people with Alcohol Addiction and Mouth Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 3 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 11 Sep 2019. 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 United Kingdom. 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 was stopped early (reason given: Staff changes and retirement of the primary investigator during the 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?
Reduction in mean number of alcohol units consumed per week (time frame: 6-12 months). 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 11 Sep 2019; AzTrials last refreshed its copy on 2 Nov 2026.