- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533802
Risk Factors for Stress-induced Alcohol Misuse: Genetic Predictors and Mediation by Personality Type (RISK)
March 30, 2023 updated by: Portsmouth Hospitals NHS Trust
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO63LY
- Portsmouth University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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).
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediately after the study visit
|
Molecular Anaylsis
Time Frame: Immediately after the study visit
|
Cheek swabs will be taken from all participant to carry out genomic DNA analysis
|
Immediately after the study visit
|
Alcohol misuse
Time Frame: immediately after the procedure
|
Measured using the alcohol use disorders identification test (AUDIT) (higher the score the worse the outcome)
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immediately after the procedure
|
Recent stressors
Time Frame: Immediately after the study visit
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Measured using the 30 item Stress Overload Scale questionnaire (higher the score, the worse the outcome)
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Immediately after the study visit
|
Life Events
Time Frame: Immediately after the study visit
|
Measured using the Life Events Checklist Questionnaire (the higher the score the worse the outcome)
|
Immediately after the study visit
|
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.
|
Immediately after the study visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2020
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
September 1, 2020
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHT/2019/63
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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