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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04533802
Other study ID # PHT/2019/63
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 26, 2020
Est. completion date September 30, 2022

Study information

Verified date January 2023
Source Portsmouth Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To examine whether variation in 'risk-taking' personality and linked genetic variants predicts susceptibility to, and resilience against, stress-induced alcohol misuse.


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


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Portsmouth University Hospital Portsmouth Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Portsmouth Hospitals NHS Trust University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol misuse Measured using the alcohol use disorders identification test (AUDIT) (higher the score the worse the outcome) immediately after the procedure
Primary Recent stressors Measured using the 30 item Stress Overload Scale questionnaire (higher the score, the worse the outcome) Immediately after the study visit
Primary Life Events Measured using the Life Events Checklist Questionnaire (the higher the score the worse the outcome) Immediately after the study visit
Primary 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. Immediately after the study visit
Primary Risk taking behaviour Measured by the Stop Signal Reaction Time Task (computer task) which measures the ability to inhibit a planned response Immediately after the study visit
Primary Molecular Anaylsis Cheek swabs will be taken from all participant to carry out genomic DNA analysis Immediately after the study visit
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