Alcohol Use, UnspecifiedRISKNCT04533802
Risk Factors for Stress-induced Alcohol Misuse: Genetic Predictors and Mediation by Personality Type
An observational study of Alcohol Use, Unspecified, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
To examine whether variation in 'risk-taking' personality and linked genetic variants predicts susceptibility to, and resilience against, stress-induced alcohol misuse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use, Unspecified
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Aug 2020to 30 Sep 2022
- 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
- All sexes
- Adult, Older adult
Study population: Participants will be patients attending Portsmouth Hospitals University Trust following alcohol-related illness/injury and an AUDIT score of greater than 15 (suggesting high risk of dependence and alcohol misuse). They will be adults (>18 years).
Who may be able to join
- Male or Female, aged (min) 18 years
- Attended Portsmouth Hospitals University Trust following illness/injury related to alcohol use
- Has a maximum AUDIT score of 15
- Is willing and able to comply with study procedures
- Willing and able to give informed consent for participation in the study.
- Must be recruited within 24 hrs of ASNS referral, and able to be tested within 48 hours of referral
Who cannot join
- ny reported/suspected intellectual/learning disabilities (e.g., Down's Syndrome), neurodevelopmental disorders (e.g., Autism, Asperger's) or acquired brain injury
- Has previously participated in this study
- Should not be under the influence of alcohol during the study (12hrs previous to taking part) - to be determined via breathalyser.
- Any history of advanced liver disease (clinical diagnosis of cirrhosis, jaundice, encephalopathy, ascites, variceal haemorrhage)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth University Hospital
Portsmouth, Hampshire, PO63LY
About this study
Official title: Personality and Genotypic Markers That Predict Individual Differences in Susceptibility to Stress-induced Alcohol Misuse: a Feasibility Study.
To examine whether variation in 'risk-taking' personality and linked genetic variants predicts susceptibility to, and resilience against, stress-induced alcohol misuse.
Read the detailed description
Alcohol misuse is a global health issue responsible for over 1 million hospital admissions per annum in the UK with a combined cost of approximately £21 billion. Chronic alcohol misuse in patients who attend hospital for alcohol-related illness/injury is common, with relapse and recidivism almost ubiquitous. Patients often report that 'stress' was a catalyst for their drinking episodes, but we do not know exactly who is most at risk, how stress leads to drinking, or the genetic basis for this risk. This research aims to seek to identify patients at higher risk of stress-induced alcohol misuse, or who are more resilient to stress in this context, using a combination of analyses ranging from genetic variants to personality tests and clinical follow-up. The ultimate goal is that patients engaging with alcohol services can receive personalised and focussed treatment and enhance recovery
- Conditions
- Alcohol Use, Unspecified
- Medical subject headings
- Alcohol Drinking
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol misuse
Measured using the alcohol use disorders identification test (AUDIT) (higher the score the worse the outcome)
Measured: immediately after the procedure
Recent stressors
Measured using the 30 item Stress Overload Scale questionnaire (higher the score, the worse the outcome)
Measured: Immediately after the study visit
Life Events
Measured using the Life Events Checklist Questionnaire (the higher the score the worse the outcome)
Measured: Immediately after the study visit
Impulse Behaviour
Measured using the the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale (UPPS-P) higher values indicate more impulsive behavior.
Measured: Immediately after the study visit
Risk taking behaviour
Measured by the Stop Signal Reaction Time Task (computer task) which measures the ability to inhibit a planned response
Measured: Immediately after the study visit
Molecular Anaylsis
Cheek swabs will be taken from all participant to carry out genomic DNA analysis
Measured: Immediately after the study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start26 Aug 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use, UnspecifiedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533802
- Sponsor's protocol ID
- PHT/2019/63
- Acronym
- RISK
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality and Genotypic Markers That Predict Individual Differences in Susceptibility to Stress-induced Alcohol Misuse: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT04533802
- Acronym / sponsor ID
- RISK / PHT/2019/63
- Conditions
- Alcohol Use, Unspecified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Portsmouth
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Sep 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.
To examine whether variation in 'risk-taking' personality and linked genetic variants predicts susceptibility to, and resilience against, stress-induced alcohol misuse.
Detailed description
Alcohol misuse is a global health issue responsible for over 1 million hospital admissions per annum in the UK with a combined cost of approximately £21 billion. Chronic alcohol misuse in patients who attend hospital for alcohol-related illness/injury is common, with relapse and recidivism almost ubiquitous. Patients often report that 'stress' was a catalyst for their drinking episodes, but we do not know exactly who is most at risk, how stress leads to drinking, or the genetic basis for this risk. This research aims to seek to identify patients at higher risk of stress-induced alcohol misuse, or who are more resilient to stress in this context, using a combination of analyses ranging from genetic variants to personality tests and clinical follow-up. The ultimate goal is that patients engaging with alcohol services can receive personalised and focussed treatment and enhance recovery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients attending Portsmouth Hospitals University Trust following alcohol-related illness/injury and an AUDIT score of greater than 15 (suggesting high risk of dependence and alcohol misuse). They will be adults (>18 years).
Key inclusion criteria (6 listed)
- Male or Female, aged (min) 18 years
- Attended Portsmouth Hospitals University Trust following illness/injury related to alcohol use
- Has a maximum AUDIT score of 15
- Is willing and able to comply with study procedures
- Willing and able to give informed consent for participation in the study.
Key exclusion criteria (4 listed)
- ny reported/suspected intellectual/learning disabilities (e.g., Down's Syndrome), neurodevelopmental disorders (e.g., Autism, Asperger's) or acquired brain injury
- Has previously participated in this study
- Should not be under the influence of alcohol during the study (12hrs previous to taking part) - to be determined via breathalyser.
- Any history of advanced liver disease (clinical diagnosis of cirrhosis, jaundice, encephalopathy, ascites, variceal haemorrhage)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alcohol misuse
Time frame: immediately after the procedure
Measured using the alcohol use disorders identification test (AUDIT) (higher the score the worse the outcome)
Recent stressors
Time frame: Immediately after the study visit
Measured using the 30 item Stress Overload Scale questionnaire (higher the score, the worse the outcome)
Life Events
Time frame: Immediately after the study visit
Measured using the Life Events Checklist Questionnaire (the higher the score the worse the outcome)
Impulse Behaviour
Time frame: Immediately after the study visit
Measured using the the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale (UPPS-P) higher values indicate more impulsive behavior.
Risk taking behaviour
Time frame: Immediately after the study visit
Measured by the Stop Signal Reaction Time Task (computer task) which measures the ability to inhibit a planned response
Molecular Anaylsis
Time frame: Immediately after the study visit
Cheek swabs will be taken from all participant to carry out genomic DNA analysis
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 3 Apr 2023.
- 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.
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?
An observational study of Alcohol Use, Unspecified, run by Portsmouth Hospitals 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 6 inclusion and 4 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 3 Apr 2023. 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 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 misuse (time frame: immediately after the procedure). The study lists 6 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 3 Apr 2023.