Alcohol AbuseDrinks:RationNCT04494594
Drinks:Ration - Combat Stress Randomized Controlled Trial
A study testing Drinks:Ration app in people with Alcohol Abuse and Mental Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption and have a broad reach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Mental Disorder, Mental Health Issue
- What is being tested?
- Drinks:Ration app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 28 Mar 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be included if they have downloaded the app onto an iOS or Android device;
- Participants will be included if they are 18 years of age or older;
- Participants will be included if they live in the UK;
- Participants will be included if they consume fourteen units (approximately 140g of alcohol) of alcohol or more per week as measured using Time-Line Follow back for Alcohol Consumption at baseline (day 0);
- Participants will be included if they provide a mobile phone number; and
- Are a veteran of the UK Armed Forces.
Who cannot join
- Participants will be excluded if they are listed as being 'red' risk by Combat Stress, which is determined by the clinical team following an initial assessment and is based on a traffic light system to assess risk, where red indicates an immediate high risk to the individual and/or others. The application of 'red' risk is applied independently of the research team and is used only where participation in the study could impact clinical treatment. The exclusion will apply only during contact list data extraction.
- Participants will be excluded if they do not have a mobile phone; and
- Participants will be excluded if they have not given Combat Stress consent for contact for research purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of a Mobile App (Drinks:Ration) and Personalized Text and Push Messaging to Reduce Alcohol Consumption in a Veteran Population: Protocol for a Randomized Controlled Trial
Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption and have a broad reach. The main objective of this participant blinded (single-blinded) Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly self-reported alcohol consumption between baseline and 3-month follow-up among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting.
Methods: In a two-arm single-blinded Randomised Controlled Trial (RCT), a smartphone app which includes interactive features designed to enhance participant motivation and personalised messaging is compared to a smartphone app which only provides Government guidance on alcohol consumption. The trial will be conducted in a veteran population who have sought help through Combat Stress; a UK veteran's mental health charity. Recruitment, consent and data collection is performed automatically through the Drinks:Ration platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption; secondary outcome measures include 1) change in baseline to 3-month follow-up (day 84) Alcohol Use Disorder Identification Test score, and 2) change in baseline to 3-month follow-up (day 84) World Health Organisation Quality of Life-BREF score to assess Quality of Adjusted Life Years. Process evaluation measures include 1) app usage, and 2) usability ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary outcomes will also be re-assessed at 6-month follow-up (day 168) to assess the longer-term benefits of the intervention and reported as a secondary outcome. The study will begin recruitment in September 2020 and is expected to require 12 months to complete. Study results should be published in 2022.
Read the detailed description
Alcohol misuse is common in the United Kingdom (UK) Armed Forces (AF), with the prevalence rates higher in the AF than the general population. Research indicates that the trend continues after personnel leave service ('veteran' or 'ex-serving' are used interchangeably in the UK). It has been estimated that more than 50% of those who have left the AF meet the criteria for hazardous alcohol use, a score of eight or above on the Alcohol Use Disorders Identification Test (AUDIT).
The last two decades has seen a proliferation in the use of digital technologies to support brief intervention management and treatment of alcohol misuse in the general public, yet little attention has focused forwards the AF community. In the late 1990's interventions were commonly delivered via a computer using CD-ROM-based programmes, but with the advent of the World Wide Web many new opportunities arose to harness increase reach, provide real-time monitoring, and offer personalised treatment. This includes the use of Short Message Service (SMS) which have been shown to be effective in encouraging people to change their behaviour.
The aim of this Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing self-reported weekly alcohol consumption between baseline and 3 months (day 84) among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting.
- Conditions
- Alcohol Abuse, Mental Disorder, Mental Health Issue
- Being tested
- Drinks:Ration app
- Keywords
- alcohol, mobile health, sms text message, push notifications
- Medical subject headings
- Alcoholism, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinks:Ration appBehavioural
Drinks:Ration (www.drinksration.app; formerly called InDEx) app has been developed following the Medical Research Council Complex Intervention Guidelines and using co-design methodology by the King's Centre for Military Health Research (at King's College London) and the University of Liverpool, supported by experts in smartphone app development, epidemiology, addiction psychiatry, and military mental health. The app is designed to support veterans drinking at a hazardous or harmful level by providing detailed advice and support over a minimum of 28-day period. The app is theoretically underpinned to enhance participants motivation and self-efficacy in modifying their alcohol consumption by means of Behaviour Change Theory in the content displayed, and the messaging sent to participants.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Not described Receives: Behavioral: Drinks:Ration app |
| Intervention | Active comparator | Not described Receives: Behavioral: Drinks:Ration app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption change
The primary outcome measure is change between self-reported alcohol consumption as measured by the 7-day timeline to Followback over the previous seven days between baseline (day 0) and 3-month follow-up (day 84)
Measured: 3 months
Secondary outcomes (2)
Change in Alcohol Use Disorder Identification Test score
Exploring the change in baseline (day 0) to follow-up (day 84) Alcohol Use Disorder Identification Test score (range between 0-40; 8 or more indicates increased risk)
Measured: 3 months
Change in Quality of Adjusted Life Years
Exploring change in baseline (day 0) to follow-up (day 84) in World Health Organization Quality of Life-BREF questionnaire to assess Quality of Adjusted Life Years (unit measure: life years)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2021
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm participant blinded (single-blinded) RCT, comparing a smartphone app (control arm) which includes feedback on baseline self-reported alcohol consumption, with a smartphone app (intervention arm) that includes individualised normative feedback, plus features designed to enhance participant motivation, app interactive feedback and self-efficacy in modifying their alcohol consumption. In this study, both the control and intervention arms will be delivered via one smartphone app known as Drinks:Ration. Participants in the control arm are given access only to alcohol consumption feedback based on publicly available health guidance and reminder messaging to consult the feedback. Those in the intervention arm are given full access to the app which includes all theoretically driven components and messaging (discussed further in Intervention section). Both arms will be asked to use the app for 28-days.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, British Army, Combat Stress
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494594
- Sponsor's protocol ID
- HR-19/20-17438
- Acronym
- Drinks:Ration
- Status last verified
- Jun 2021
- First submitted
- 23 Jul 2020
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To promote open science, consent will be sought from participants to share their data anonymously for research purposes. This data will be released upon completion of the study. Only questionnaire response, remote measurement technology data and alcohol consumption statistics will be shared. All data will be de-identified, and no personal data will be released.
Publications
Leightley D, Rona RJ, Shearer J, Williamson C, Gunasinghe C, Simms A, Fear NT, Goodwin L, Murphy D. Evaluating the Efficacy of a Mobile App (Drinks:Ration) and Personalized Text and Push Messaging to Reduce Alcohol Consumption in a Veteran Population: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Oct 2;9(10):e19720. doi: 10.2196/19720.
PubMed 33006569Williamson C, White K, Rona RJ, Simms A, Fear NT, Goodwin L, Murphy D, Leightley D. Smartphone-based alcohol interventions: A systematic review on the role of notifications in changing behaviors toward alcohol. Subst Abus. 2022;43(1):1231-1244. doi: 10.1080/08897077.2022.2074595.
PubMed 35670777Puddephatt JA, Leightley D, Palmer L, Jones N, Mahmoodi T, Drummond C, Rona RJ, Fear NT, Field M, Goodwin L. A Qualitative Evaluation of the Acceptability of a Tailored Smartphone Alcohol Intervention for a Military Population: Information About Drinking for Ex-Serving Personnel (InDEx) App. JMIR Mhealth Uhealth. 2019 May 24;7(5):e12267. doi: 10.2196/12267.
PubMed 31127726Leightley D, Puddephatt JA, Jones N, Mahmoodi T, Chui Z, Field M, Drummond C, Rona RJ, Fear NT, Goodwin L. A Smartphone App and Personalized Text Messaging Framework (InDEx) to Monitor and Reduce Alcohol Use in Ex-Serving Personnel: Development and Feasibility Study. JMIR Mhealth Uhealth. 2018 Sep 11;6(9):e10074. doi: 10.2196/10074.
PubMed 30206054Leightley D, Puddephatt JA, Goodwin L, Rona R, Fear NT. InDEx: Open Source iOS and Android Software for Self-Reporting and Monitoring of Alcohol Consumption. J Open Res Softw. 2018 Mar 23;6:13. doi: 10.5334/jors.207.
PubMed 29795769Leightley D, Williamson C, Rona RJ, Carr E, Shearer J, Davis JP, Simms A, Fear NT, Goodwin L, Murphy D. Evaluating the Efficacy of the Drinks:Ration Mobile App to Reduce Alcohol Consumption in a Help-Seeking Military Veteran Population: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jun 20;10(6):e38991. doi: 10.2196/38991.
PubMed 35724966Trompeter N, Williamson C, Rona RJ, Carr E, Simms A, Agwuna J, Fear NT, Goodwin L, Murphy D, Shearer J, Leightley D. Shorter communications: Exploring the impact of a brief smartphone-based alcohol intervention app (DrinksRation) on the quality of life of UK military veterans. Behav Res Ther. 2024 Jun;177:104540. doi: 10.1016/j.brat.2024.104540. Epub 2024 Apr 6.
PubMed 38598898
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a Mobile App (Drinks:Ration) and Personalized Text and Push Messaging to Reduce Alcohol Consumption in a Veteran Population: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04494594
- Acronym / sponsor ID
- Drinks:Ration / HR-19/20-17438
- Conditions
- Alcohol Abuse, Mental Disorder, Mental Health Issue
- Keywords
- alcohol, mobile health, sms text message, push notifications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Liverpool, British Army, Combat Stress
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 31 Jul 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.
Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption and have a broad reach. The main objective of this participant blinded (single-blinded) Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly self-reported alcohol consumption between baseline and 3-month follow-up among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting.
Methods: In a two-arm single-blinded Randomised Controlled Trial (RCT), a smartphone app which includes interactive features designed to enhance participant motivation and personalised messaging is compared to a smartphone app which only provides Government guidance on alcohol consumption. The trial will be conducted in a veteran population who have sought help through Combat Stress; a UK veteran's mental health charity. Recruitment, consent and data collection is performed automatically through the Drinks:Ration platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption; secondary outcome measures include 1) change in baseline to 3-month follow-up (day 84) Alcohol Use Disorder Identification Test score, and 2) change in baseline to 3-month follow-up (day 84) World Health Organisation Quality of Life-BREF score to assess Quality of Adjusted Life Years. Process evaluation measures include 1) app usage, and 2) usability ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary outcomes will also be re-assessed at 6-month follow-up (day 168) to assess the longer-term benefits of the intervention and reported as a secondary outcome. The study will begin recruitment in September 2020 and is expected to require 12 months to complete. Study results should be published in 2022.
Detailed description
Alcohol misuse is common in the United Kingdom (UK) Armed Forces (AF), with the prevalence rates higher in the AF than the general population. Research indicates that the trend continues after personnel leave service ('veteran' or 'ex-serving' are used interchangeably in the UK). It has been estimated that more than 50% of those who have left the AF meet the criteria for hazardous alcohol use, a score of eight or above on the Alcohol Use Disorders Identification Test (AUDIT).
The last two decades has seen a proliferation in the use of digital technologies to support brief intervention management and treatment of alcohol misuse in the general public, yet little attention has focused forwards the AF community. In the late 1990's interventions were commonly delivered via a computer using CD-ROM-based programmes, but with the advent of the World Wide Web many new opportunities arose to harness increase reach, provide real-time monitoring, and offer personalised treatment. This includes the use of Short Message Service (SMS) which have been shown to be effective in encouraging people to change their behaviour.
The aim of this Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing self-reported weekly alcohol consumption between baseline and 3 months (day 84) among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This is a two-arm participant blinded (single-blinded) RCT, comparing a smartphone app (control arm) which includes feedback on baseline self-reported alcohol consumption, with a smartphone app (intervention arm) that includes individualised normative feedback, plus features designed to enhance participant motivation, app interactive feedback and self-efficacy in modifying their alcohol consumption. In this study, both the control and intervention arms will be delivered via one smartphone app known as Drinks:Ration. Participants in the control arm are given access only to alcohol consumption feedback based on publicly available health guidance and reminder messaging to consult the feedback. Those in the intervention arm are given full access to the app which includes all theoretically driven components and messaging (discussed further in Intervention section). Both arms will be asked to use the app for 28-days.
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Behavioral: Drinks:Ration app |
| Intervention | Active comparator | Behavioral: Drinks:Ration app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants will be included if they have downloaded the app onto an iOS or Android device;
- Participants will be included if they are 18 years of age or older;
- Participants will be included if they live in the UK;
- Participants will be included if they consume fourteen units (approximately 140g of alcohol) of alcohol or more per week as measured using Time-Line Follow back for Alcohol Consumption at baseline (day 0);
- Participants will be included if they provide a mobile phone number; and
Key exclusion criteria (3 listed)
- Participants will be excluded if they are listed as being 'red' risk by Combat Stress, which is determined by the clinical team following an initial assessment and is based on a traffic light system to assess risk, where red indicates an immediate high risk to the individual and/or others. The application of 'red' risk is applied independently of the research team and is used only where participation in the study could impact clinical treatment. The exclusion will apply only during contact list data extraction.
- Participants will be excluded if they do not have a mobile phone; and
- Participants will be excluded if they have not given Combat Stress consent for contact for research purposes.
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 |
|---|---|---|
| Drinks:Ration appDrinks:Ration (www.drinksration.app; formerly called InDEx) app has been developed following the Medical Research Council Complex Intervention Guidelines and using co-design methodology by the King's Centre for Military Health Research (at King's College London) and the University of Liverpool, supported by experts in smartphone app development, epidemiology, addiction psychiatry, and military mental health. The app is designed to support veterans drinking at a hazardous or harmful level by providing detailed advice and support over a minimum of 28-day period. The app is theoretically underpinned to enhance participants motivation and self-efficacy in modifying their alcohol consumption by means of Behaviour Change Theory in the content displayed, and the messaging sent to participants. | Behavioural | Control, Intervention |
Primary outcome
Alcohol consumption change
Time frame: 3 months
The primary outcome measure is change between self-reported alcohol consumption as measured by the 7-day timeline to Followback over the previous seven days between baseline (day 0) and 3-month follow-up (day 84)
2 secondary outcomes
Change in Alcohol Use Disorder Identification Test score
Time frame: 3 months
Change in Quality of Adjusted Life Years
Time frame: 3 months
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 14 Oct 2022.
- Background: PubMed 33006569Leightley D, Rona RJ, Shearer J, Williamson C, Gunasinghe C, Simms A, Fear NT, Goodwin L, Murphy D. Evaluating the Efficacy of a Mobile App (Drinks:Ration) and Personalized Text and Push Messaging to Reduce Alcohol Consumption in a Veteran Population: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Oct 2;9(10):e19720. doi: 10.2196/19720.
- Background: PubMed 35670777Williamson C, White K, Rona RJ, Simms A, Fear NT, Goodwin L, Murphy D, Leightley D. Smartphone-based alcohol interventions: A systematic review on the role of notifications in changing behaviors toward alcohol. Subst Abus. 2022;43(1):1231-1244. doi: 10.1080/08897077.2022.2074595.
- Results publication: PubMed 31127726Puddephatt JA, Leightley D, Palmer L, Jones N, Mahmoodi T, Drummond C, Rona RJ, Fear NT, Field M, Goodwin L. A Qualitative Evaluation of the Acceptability of a Tailored Smartphone Alcohol Intervention for a Military Population: Information About Drinking for Ex-Serving Personnel (InDEx) App. JMIR Mhealth Uhealth. 2019 May 24;7(5):e12267. doi: 10.2196/12267.
- Results publication: PubMed 30206054Leightley D, Puddephatt JA, Jones N, Mahmoodi T, Chui Z, Field M, Drummond C, Rona RJ, Fear NT, Goodwin L. A Smartphone App and Personalized Text Messaging Framework (InDEx) to Monitor and Reduce Alcohol Use in Ex-Serving Personnel: Development and Feasibility Study. JMIR Mhealth Uhealth. 2018 Sep 11;6(9):e10074. doi: 10.2196/10074.
- Results publication: PubMed 29795769Leightley D, Puddephatt JA, Goodwin L, Rona R, Fear NT. InDEx: Open Source iOS and Android Software for Self-Reporting and Monitoring of Alcohol Consumption. J Open Res Softw. 2018 Mar 23;6:13. doi: 10.5334/jors.207.
- Results publication: PubMed 35724966Leightley D, Williamson C, Rona RJ, Carr E, Shearer J, Davis JP, Simms A, Fear NT, Goodwin L, Murphy D. Evaluating the Efficacy of the Drinks:Ration Mobile App to Reduce Alcohol Consumption in a Help-Seeking Military Veteran Population: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jun 20;10(6):e38991. doi: 10.2196/38991.
- Derived from this study: PubMed 38598898Trompeter N, Williamson C, Rona RJ, Carr E, Simms A, Agwuna J, Fear NT, Goodwin L, Murphy D, Shearer J, Leightley D. Shorter communications: Exploring the impact of a brief smartphone-based alcohol intervention app (DrinksRation) on the quality of life of UK military veterans. Behav Res Ther. 2024 Jun;177:104540. doi: 10.1016/j.brat.2024.104540. Epub 2024 Apr 6.
- Drinks:Ration websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. To promote open science, consent will be sought from participants to share their data anonymously for research purposes. This data will be released upon completion of the study. Only questionnaire response, remote measurement technology data and alcohol consumption statistics will be shared. All data will be de-identified, and no personal data will be released.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drinks:Ration app in people with Alcohol Abuse and Mental Disorder, run by King's College London 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 6 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: finished, as of the sponsor's last update on 14 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Alcohol consumption change (time frame: 3 months). 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 NCT04494594, which also lists 7 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 14 Oct 2022.